From 89df64945b38fbd581dc2b8254d87232df28ee73 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Wed, 31 May 2023 16:24:06 -0500 Subject: [PATCH 01/50] Updated to newer version of 4 --- sushi-config.yaml | 1 + 1 file changed, 1 insertion(+) diff --git a/sushi-config.yaml b/sushi-config.yaml index 35730235..abd8aa90 100755 --- a/sushi-config.yaml +++ b/sushi-config.yaml @@ -11,6 +11,7 @@ status: draft license: CC0-1.0 version: 0.2.0 fhirVersion: 4.0.1 +#fhirVersion: 4.3.0 copyrightYear: 2021+ releaseLabel: ci-build publisher: From b33673efe62d64f60b51f001bf25549f7f016321 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Wed, 31 May 2023 16:26:05 -0500 Subject: [PATCH 02/50] Switched Study Participant code to NCIT for convenience --- input/fsh/CodeSystem-NCIt.fsh | 1 + input/fsh/Profile-StudyGroup.fsh | 2 +- 2 files changed, 2 insertions(+), 1 deletion(-) diff --git a/input/fsh/CodeSystem-NCIt.fsh b/input/fsh/CodeSystem-NCIt.fsh index f8e0b798..ea03eb7c 100644 --- a/input/fsh/CodeSystem-NCIt.fsh +++ b/input/fsh/CodeSystem-NCIt.fsh @@ -11,3 +11,4 @@ Description: "NCI Thesaurus (NCIt) provides reference terminology for many NCI a * #C3270 "Neuroblastoma" * #C5437 "Extracranial Neuroblastoma" * #C84505 "Tetralogy of Fallot" +* #C142710 "Study Participant" diff --git a/input/fsh/Profile-StudyGroup.fsh b/input/fsh/Profile-StudyGroup.fsh index a5c54d54..e7ac7471 100644 --- a/input/fsh/Profile-StudyGroup.fsh +++ b/input/fsh/Profile-StudyGroup.fsh @@ -5,7 +5,7 @@ Title: "NCPI Study Group" Description: "Grouping subject participation within a research study is helpful to provide definitive lists of participants that fit a specific criteria such as *All Participants* or *Participants From a Particular Consent Group*, etc. " * ^version = "0.0.1" * ^status = #draft -* code = $sct#44807982 "Participant in research study" +* code = $ncit#C142710 "Study Participant" * quantity 1..1 * actual = true * type = #person From a49d9a5ecb81f42d027d50b873456214a5d25b02 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Wed, 31 May 2023 16:27:25 -0500 Subject: [PATCH 03/50] Added Consortium Profile --- input/fsh/Example-RawQuestionnaire.fsh | 2 +- input/fsh/Example-ResearchStudy.fsh | 10 ++++++++++ input/fsh/Profile-NCPI-ResearchStudy.fsh | 1 + input/fsh/Profile-ResearchConsortium.fsh | 9 +++++++++ ...ructureDefinition-ncpi-research-consortium-intro.md | 7 +++++++ ...ructureDefinition-ncpi-research-consortium-notes.md | 1 + input/pagecontent/research_study.md | 5 +++++ input/pagecontent/use_case_tabular_data.md | 2 +- 8 files changed, 35 insertions(+), 2 deletions(-) create mode 100644 input/fsh/Profile-ResearchConsortium.fsh create mode 100644 input/pagecontent/StructureDefinition-ncpi-research-consortium-intro.md create mode 100644 input/pagecontent/StructureDefinition-ncpi-research-consortium-notes.md diff --git a/input/fsh/Example-RawQuestionnaire.fsh b/input/fsh/Example-RawQuestionnaire.fsh index 3474e478..9b5098e8 100644 --- a/input/fsh/Example-RawQuestionnaire.fsh +++ b/input/fsh/Example-RawQuestionnaire.fsh @@ -62,7 +62,7 @@ Title: "Example of a QuestionnaireResponse to Represent Raw Data" Description: "A Single row of data represented in FHIR as a QuestionnaireResponse" * questionnaire = "https://nih-ncpi.github.io/ncpi-fhir-ig/data-dictionary/study-name/demographics" * status = #completed -* subject = Reference(example-sum-patient-1) +* subject = Reference(ncpi-research-study-01-patient-01) * item * linkId = "subjectid" * text = "Subject ID" diff --git a/input/fsh/Example-ResearchStudy.fsh b/input/fsh/Example-ResearchStudy.fsh index b9c2358d..4c48c037 100644 --- a/input/fsh/Example-ResearchStudy.fsh +++ b/input/fsh/Example-ResearchStudy.fsh @@ -7,6 +7,16 @@ * Examples for ResearchSubjects * Examples of Patients */ +Instance: ncpi-research-consortium-01 +InstanceOf: ResearchConsortium +Usage: #example +Description: "Example Consortium" +* name = "Example Consortium" +* alias[0] = "ExCNS" +* telecom + * system = #url + * value = "www.consortium-home.org" + /** * The Research Study diff --git a/input/fsh/Profile-NCPI-ResearchStudy.fsh b/input/fsh/Profile-NCPI-ResearchStudy.fsh index e5535d7c..0fe1cfcd 100644 --- a/input/fsh/Profile-NCPI-ResearchStudy.fsh +++ b/input/fsh/Profile-NCPI-ResearchStudy.fsh @@ -8,3 +8,4 @@ Description: "The NCPI Research Study is based upon the core FHIR ResearchStudy * category.coding = $ncpi#StudyCohort "Study Cohort" * enrollment 1..* * enrollment only Reference(StudyGroup) +* sponsor only Reference(ResearchConsortium) diff --git a/input/fsh/Profile-ResearchConsortium.fsh b/input/fsh/Profile-ResearchConsortium.fsh new file mode 100644 index 00000000..a4755a72 --- /dev/null +++ b/input/fsh/Profile-ResearchConsortium.fsh @@ -0,0 +1,9 @@ +Profile: ResearchConsortium +Parent: Organization +Id: ncpi-research-consortium +Title: "Research Consortium" +Description: "A FHIR Organization representing a single consortium of which one or more NCPI Research Studies is a member" +* ^version = "0.1.0" +* ^status = #draft +* name 1..1 + diff --git a/input/pagecontent/StructureDefinition-ncpi-research-consortium-intro.md b/input/pagecontent/StructureDefinition-ncpi-research-consortium-intro.md new file mode 100644 index 00000000..96a8eea5 --- /dev/null +++ b/input/pagecontent/StructureDefinition-ncpi-research-consortium-intro.md @@ -0,0 +1,7 @@ +### Added Profile Restrictions +Each Consortium __must__ have: +* a **meaningful name**. + +It is strongly recommended: +* **common IDs** and **acronyms** be provided as **aliases**. +* The **telecom** property can be used to provide a URL pointing to the consortium's website. \ No newline at end of file diff --git a/input/pagecontent/StructureDefinition-ncpi-research-consortium-notes.md b/input/pagecontent/StructureDefinition-ncpi-research-consortium-notes.md new file mode 100644 index 00000000..04fe2328 --- /dev/null +++ b/input/pagecontent/StructureDefinition-ncpi-research-consortium-notes.md @@ -0,0 +1 @@ +The ResearchConsortium provides a clean organizational component to represent studies' participation in a Consortium through the study's __sponsor__ property. This permits consortium member studies to be more easily found via standard FHIR searches. diff --git a/input/pagecontent/research_study.md b/input/pagecontent/research_study.md index 77aa2a24..b5d9afee 100644 --- a/input/pagecontent/research_study.md +++ b/input/pagecontent/research_study.md @@ -6,6 +6,9 @@ The [NCPI ResearchStudy](StructureDefinition-ncpi-research-study.html) profile i Patient resources are associated with the study by way of the ResearchSubject resource as well as membership in one or more of the StudyGroup resources. +#### ResearchConsortium +When capturing studies that are a part of a consortium, the [NCPI ResearchConsortium](StructureDefinition-research-consortium.html) profile should be defined and referenced from the participating studies via the studies' __sponsor__ property. + ### Conventions For each NCPI Research Study resource, there **must** be at least one [StudyGroup](StructureDefinition-study-group.html). @@ -23,6 +26,8 @@ In addition to a more comprehensive Study Group, Research Studies that exist alo * One or more StudyGroup resources as references in the enrollment property. * Study URLs can be attached via the relatedArtifact property. +* [ResearchConsortium](StructureDefinition-research-consortium.html) can be used to represent studies' participation within a consortium. Using ResearchConsortium provides the ability to search for participating studies using the ResearchStudy's sponsor search parameter. + * [StudyGroup](StructureDefinition-study-group.html) provides information about the study as the number of subjects (quantity) as well as an explicit listing of the Patients as references in the group's member property when the Study resource is present in a server with row-level data. The can be more than one StudyGroup associated with a given Study. * [ResearchSubject](https://hl7.org/fhir/researchsubject.html) provides the linkage between a Patient and a ResearchStudy. diff --git a/input/pagecontent/use_case_tabular_data.md b/input/pagecontent/use_case_tabular_data.md index d04a7005..50813ba5 100644 --- a/input/pagecontent/use_case_tabular_data.md +++ b/input/pagecontent/use_case_tabular_data.md @@ -58,4 +58,4 @@ Each Questionnaire must have a unique URL. ##### QuestionnaireResponse Each response represents a single row from the table their corresponding Questionnaire represents. The response refers back to the questionnaire by way of providing the property, *questionnaire*, the value from the corresponding Questionnaire's *url* property. -Each item must have a linkId that matches one of the linkIds from the Questionnaire and their valueX must correspond to the type specified by the item's *type* definition. This will fail during FHIR validation if the data type is not what the Questionnaire specified it should be. \ No newline at end of file +Each item must have a linkId that matches one of the linkIds from the Questionnaire and their valueX must correspond to the type specified by the item's *type* definition. This will fail during FHIR validation if the data type is not what the Questionnaire specified it should be. From fcc8ea1048858a1bb3abd41d3866c233d3db86f4 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Fri, 9 Jun 2023 16:51:15 -0500 Subject: [PATCH 04/50] Further refinements to research study with better examples --- input/fsh/Alias.fsh | 2 + input/fsh/CodeSystem-Mondo.fsh | 2 + input/fsh/CodeSystem-NcpiStudyType.fsh | 21 + input/fsh/CodeSystem-NihConsentCodes.fsh | 16 + input/fsh/Example-CMG-ResearchStudy.fsh | 139 ++ input/fsh/Example-ResearchStudy.fsh | 41 + input/fsh/Profile-NCPI-ResearchStudy.fsh | 2 +- input/fsh/Profile-ResearchConsent.fsh | 36 + input/fsh/Profile-ResearchConsortium.fsh | 3 +- input/fsh/Profile-ResearchStudySubject.fsh | 15 + input/fsh/ValueSet-NcpiConsentCodes.fsh | 6 + ...tureDefinition-research-study-consent.json | 2217 +++++++++++++++++ 12 files changed, 2497 insertions(+), 3 deletions(-) create mode 100644 input/fsh/CodeSystem-NcpiStudyType.fsh create mode 100644 input/fsh/CodeSystem-NihConsentCodes.fsh create mode 100644 input/fsh/Example-CMG-ResearchStudy.fsh create mode 100644 input/fsh/Profile-ResearchConsent.fsh create mode 100644 input/fsh/Profile-ResearchStudySubject.fsh create mode 100644 input/fsh/ValueSet-NcpiConsentCodes.fsh create mode 100644 input/resources/StructureDefinition-research-study-consent.json diff --git a/input/fsh/Alias.fsh b/input/fsh/Alias.fsh index e3fe20f0..3649652a 100755 --- a/input/fsh/Alias.fsh +++ b/input/fsh/Alias.fsh @@ -36,6 +36,7 @@ Alias: $observation-category = http://terminology.hl7.org/CodeSystem/observation Alias: $refseq = http://www.ncbi.nlm.nih.gov/refseq Alias: $varnomen = http://varnomen.hgvs.org Alias: $umls = https://uts.nlm.nih.gov/uts/umls +Alias: $nihcc = https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/nih-consent // ValueSet Alias: $v3-FamilyMember = http://terminology.hl7.org/ValueSet/v3-FamilyMember @@ -67,4 +68,5 @@ Alias: $condition-interitanc-codes = http://fhir.ncpi-project-forge.io/ValueSet/ // NCPI Observations Alias: $ncpi = https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/ncpi Alias: $ncpi_datatypes = https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/ncpi-data-types +Alias: $ncpi-study-types = https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/ncpi-study-types Alias: $ucum = http://unitsofmeasure.org diff --git a/input/fsh/CodeSystem-Mondo.fsh b/input/fsh/CodeSystem-Mondo.fsh index bdb2f7d1..c3a298a1 100644 --- a/input/fsh/CodeSystem-Mondo.fsh +++ b/input/fsh/CodeSystem-Mondo.fsh @@ -11,3 +11,5 @@ Description: "The Mondo Disease Ontology (Mondo) aims to harmonize disease defin * #MONDO:0005072 "neuroblastoma" * #MONDO:0002749 "extracranial neuroblastoma" * #MONDO:0008542 "tetralogy of fallot" +* #MONDO:0016054 "cerebral malformation" +* #MONDO:0016033 "Cornelia de Lange syndrome" diff --git a/input/fsh/CodeSystem-NcpiStudyType.fsh b/input/fsh/CodeSystem-NcpiStudyType.fsh new file mode 100644 index 00000000..9eed3b90 --- /dev/null +++ b/input/fsh/CodeSystem-NcpiStudyType.fsh @@ -0,0 +1,21 @@ +CodeSystem: NcpiStudyType +Id: ncpi-study-type +Title: "NCPI Study Type" +Description: "Enumerated List of Research Study Types used in NCPI Funded studies." +* ^url = $ncpi-study-types +* ^version = "0.1.0" +* ^status = #active +* ^experimental = false +* ^publisher = "NCPI FHIR Works" +* ^content = #fragment +* #Family "Family" +* #Cohort "Cohort" +* #Mixed "Mixed" +* #Repository "Repository" +* #RNA-Sequencing "RNA Sequencing" +* #Parent-Offspring-Trios "Parent-Offspring Trios" +* #Cross-Sectional "Cross-Sectional" +* #Control-Set "Control Set" +* #Tumor-vs-Matched-Normal "Tumor vs. Matched-Normal" +* #Observational "Observational" +* #Longitudinal "Longitudinal" diff --git a/input/fsh/CodeSystem-NihConsentCodes.fsh b/input/fsh/CodeSystem-NihConsentCodes.fsh new file mode 100644 index 00000000..03f52568 --- /dev/null +++ b/input/fsh/CodeSystem-NihConsentCodes.fsh @@ -0,0 +1,16 @@ +CodeSystem: NihConsentCodes +Id: nih-consent +Title: "NIH Consent Codes" +Description: "A set of terms describing the data use limitations associated with a given consent group." +* ^version = "0.1.0" +* ^status = #active +* ^url = $nihcc +* #GRU "General Research Use" +* #HMB "Health/Medical/Biomedical" +* #DS "Disease-Specific (Disease/Trait/Exposure)" +* #IRB "IRB approval required" +* #PUB "Publication required" +* #COL "Collaboration Required" +* #NPU "Not-for-profit use only" +* #MDS "Methods" +* #GSO "Genetic studies only" diff --git a/input/fsh/Example-CMG-ResearchStudy.fsh b/input/fsh/Example-CMG-ResearchStudy.fsh new file mode 100644 index 00000000..48c8441a --- /dev/null +++ b/input/fsh/Example-CMG-ResearchStudy.fsh @@ -0,0 +1,139 @@ +// We'll use the Baylor Hopkins CMG DbGAP resources to build this example +// which will conform to the current NCPI Research Study model. +// +// https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000711.v7.p2 +// +// This particular study has sufficient complexity to show the most +// important aspects of the current model's design without being too cumbersome +// to fully represent. + +// The Consortium resource provides a single point of reference to link +// together research studies that exist under the single umbrella. +Instance: cmg-research-consortium +InstanceOf: ResearchConsortium +Title: "The Center for Mendelian Genomics Consortium (CMG) Consortium" +Usage: #example +Description: "The Center for Mendelian Genomics Consortium." +* name = "Center for Mendelian Genomics Consortium" +* alias[0] = "CMG" +* telecom + * system = #url + * value = "http://mendelian.org/" + +Instance: cmg-research-study-bhcmg +InstanceOf: NcpiResearchStudy +Title: "Baylor Hopkins Center for Mendelian Genomics (BH CMG)" +Usage: #example +Description: "The Centers for Mendelian Genomics project uses next-generation sequencing and computational approaches to discover the genes and variants that underlie Mendelian conditions. By discovering genes that cause Mendelian conditions, we will expand our understanding of their biology to facilitate diagnosis and new treatments." +// Notice that we can use the DbGaP study ID for easier searching +* identifier[0] + * system = "http://mendelian.org/fhir" + * value = "BH-CMG" +* identifier[1] + * system = "https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=" + * value = "phs000711" +* title = "Baylor Hopkins Center for Mendelian Genomics (BH CMG)" +* description = "The Centers for Mendelian Genomics project uses next-generation sequencing and computational approaches to discover the genes and variants that underlie Mendelian conditions. By discovering genes that cause Mendelian conditions, we will expand our understanding of their biology to facilitate diagnosis and new treatments." +* status = #completed +* sponsor = Reference(cmg-research-consortium) +* category + * coding + * system = $ncpi + * code = #StudyCohort + * display = "Study Cohort" +* primaryPurposeType = $ncpi-study-types#Mixed "Mixed" +* focus[+] = $mondo#MONDO:0016054 "cerebral malformation" +* focus[+] = $hpo#HP:0030853 "Heterotaxy" +* focus[+] = $mondo#MONDO:0016033 "Cornelia de Lange syndrome" +// This particular study doesn't have a specific +* relatedArtifact[0] + * type = #derived-from + * label = "DbGaP" + * url = "phs000711" +* relatedArtifact[+] + * type = #documentation + * label = "Citation" + * citation = "Gonzaga-Jauregui C, Lupski JR, Gibbs RA. Human genome sequencing in health and disease. Annu Rev Med. 2012;63:35-61. doi: 10.1146/annurev-med-051010-162644. PMID: 22248320; PMCID: PMC3656720." + * url = "https://pubmed.ncbi.nlm.nih.gov/22248320/" +* enrollment = Reference(cmg-research-study-bhcmg-group) + + +Instance: cmg-research-study-bhcmg-group +InstanceOf: StudyGroup +Title: "BH CMG Study Participants" +Usage: #example +Description: "BH-CMG study's entire population" +* name = "BH-CMG Study Participants" +* quantity = 2445 +* actual = true +* type = #person + +Instance: hmb-npu-consent +InstanceOf: ResearchStudyConsent +Title: "HMB-NPU Consent" +Usage: #example +Description: "Consented with Health/Medical/Biomedical + Not for profit use" +* status = #draft +* scope = #research +* category.coding[0] = $nihcc#HMB +* category.coding[1] = $nihcc#NPU +* category.text = "HMB-NPU" + +Instance: cmg-research-study-subject-cmg-hmb-npu +InstanceOf: ResearchStudySubject +Title: "Participants consented under HMB-NPU" +Usage: #example +Description: "CMG Consent Group, Health/Medical/Biomedical + Not for profit use" +* title = "BH-CMG HMB-NPU Consent Study Subject" +* description = "CMG Consent Group, Health/Medical/Biomedical + Not for profit use" +* status = #completed +* partOf = Reference(cmg-research-study-bhcmg) +* extension[consent].valueReference = Reference(hmb-npu-consent) +* enrollment = Reference(cmg-research-study-bhcmg-consent-group-hmb-npu) +// Do we want to link these back to the consortium? +* sponsor = Reference(cmg-research-consortium) + +Instance: cmg-research-study-bhcmg-consent-group-hmb-npu +InstanceOf: StudyGroup +Title: "Participants consented under HMB-NPU" +Usage: #example +Description: "BH-CMG study's population consented under Health/Medical/Biomedical + Not for profit use" +* name = "BM-CMG Study HMB-NPU Participants" +* quantity = 1665 +* actual = true +* type = #person + +Instance: hmb-irb-npu-consent +InstanceOf: ResearchStudyConsent +Title: "HMB-IRB-NPU Consent" +Usage: #example +Description: "Consented with Health/Medical/Biomedical + IRB Required + Not for profit use" +* status = #draft +* scope = #research +* category.coding[0] = $nihcc#HMB +* category.coding[1] = $nihcc#IRB +* category.coding[2] = $nihcc#NPU +* category.text = "HMB-IRB-NPU" + +Instance: cmg-research-study-subject-cmg-hmb-irb-npu +InstanceOf: ResearchStudySubject +Title: "Participants consented under HMB-IRB-NPU" +Usage: #example +Description: "CMG Consent Group, HMB-IRB-NPU" +* title = "BH-CMG HMB-IRB-NPU Consent Study Subject" +* status = #completed +* partOf = Reference(cmg-research-study-bhcmg) +* extension[consent].valueReference = Reference(hmb-irb-npu-consent) +* enrollment = Reference(cmg-research-study-bhcmg-group-hmb-irb-npu) + +Instance: cmg-research-study-bhcmg-group-hmb-irb-npu +InstanceOf: StudyGroup +Title: "Participants consented under HMB-IRB-NPU" +Usage: #example +Description: "BH-CMG study's population consented under Health/Medical/Biomedical + IRB Approval Required + Not for profit use" +* name = "BM-CMG Study HMB-IRB-NPU Participants" +* quantity = 780 +* actual = true +* type = #person + + diff --git a/input/fsh/Example-ResearchStudy.fsh b/input/fsh/Example-ResearchStudy.fsh index 4c48c037..993d7648 100644 --- a/input/fsh/Example-ResearchStudy.fsh +++ b/input/fsh/Example-ResearchStudy.fsh @@ -35,6 +35,34 @@ Description: "An example research study" * display = "Study Cohort" * enrollment = Reference(ncpi-research-study-01-group-01-main) +Instance: gru-consent +InstanceOf: ResearchStudyConsent +Usage: #example +Description: "Example Consent resource" +* status = #draft +* scope = #research +* category = $nihcc#GRU + +Instance: ds-bav-consent +InstanceOf: ResearchStudyConsent +Usage: #example +Description: "Example of Disease Specific Consent resource" +* status = #draft +* scope = #research +* category = $nihcc#DS +* extension[diseaseAbbreviation].valueString = "DS-BAV" + + +Instance: ncpi-research-study-subject-01 +InstanceOf: ResearchStudySubject +Usage: #example +Description: "An example of an R4 Research Study Subject which connects subjects to a research study and their consent" +* title = "Example research study subject" +* status = #completed +* partOf = Reference(ncpi-research-study-01) +* extension[consent].valueReference = Reference(gru-consent) +* enrollment = Reference(ncpi-research-study-01-conset-group-01-main) + Instance: ncpi-research-study-01-group-01-main InstanceOf: StudyGroup Usage: #example @@ -46,6 +74,19 @@ Description: "Study 01's complete enrollment" * member[0].entity = Reference(ncpi-research-study-01-patient-01) * member[+].entity = Reference(ncpi-research-study-01-patient-02) +Instance: ncpi-research-study-01-conset-group-01-main +InstanceOf: StudyGroup +Usage: #example +Description: "Study 01's Group consented under GRU" +* name = "Study 01's consented participants" +* quantity = 2 +* actual = true +* type = #person +* member[0].entity = Reference(ncpi-research-study-01-patient-01) +* member[+].entity = Reference(ncpi-research-study-01-patient-02) + + + Instance: ncpi-research-study-01-patient-01 InstanceOf: Patient Usage: #example diff --git a/input/fsh/Profile-NCPI-ResearchStudy.fsh b/input/fsh/Profile-NCPI-ResearchStudy.fsh index 0fe1cfcd..d2370821 100644 --- a/input/fsh/Profile-NCPI-ResearchStudy.fsh +++ b/input/fsh/Profile-NCPI-ResearchStudy.fsh @@ -6,6 +6,6 @@ Description: "The NCPI Research Study is based upon the core FHIR ResearchStudy * ^version = "0.0.1" * ^status = #draft * category.coding = $ncpi#StudyCohort "Study Cohort" -* enrollment 1..* +* enrollment 1..1 * enrollment only Reference(StudyGroup) * sponsor only Reference(ResearchConsortium) diff --git a/input/fsh/Profile-ResearchConsent.fsh b/input/fsh/Profile-ResearchConsent.fsh new file mode 100644 index 00000000..45ed9fbf --- /dev/null +++ b/input/fsh/Profile-ResearchConsent.fsh @@ -0,0 +1,36 @@ +Invariant: disease-specific-consent-code +Description: "Disease Specific components reflect the content that appears after the DS- portion of the NIH style consent code." +Expression: "valueString.matches('DS-[A-Z]+')" +Severity: #error + +//https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-consent-disease-abbreviation +Invariant: completed-conset-code +Description: "If category is DS then there must be a ResearchConsentDiseaseAbbreviation" +Expression: "!category.where(coding.where(system&'|'&code = 'https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/nih-consent|DS').exists()).exists() or extension.where(url=https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-consent-disease-abbreviation).exists()" +Severity: #error + +Extension: ResearchConsentDiseaseAbbreviation +Id: research-consent-disease-abbreviation +Title: "Research Consent Disease Abbreviation" +Description: "Full code string for disease specific consent abbreviations" +* value[x] only string +* obeys disease-specific-consent-code + +// The current version of SMILES CDR that we are using doesn't support +// version 4.3.0 resources, and when generating Consent based profiles with +// version 4.0.1 resource, sushi generates invalid profiles. +// +// This profile exists in the resources directory until we have migrated all +// R4 servers to a more recent version of HAPI. +// +// Profile: ResearchStudyConsent +// Parent: Consent +// Id: research-study-consent +// Title: "Research Study Consent" +// Description: "A ResearchStudyConsent represents the core NIH Consent properties as they apply when consenting subjects to a research study" +// * ^version = "0.1.0" +// * ^status = #draft +// * category from nih-consent-codes (extensible) +// * extension contains ResearchConsentDiseaseAbbreviation named diseaseAbbreviation 0..1 +// * extension[diseaseAbbreviation] ^short = "Consent Code Disease Abbreviation" +// * extension[diseaseAbbreviation].value[x] only string diff --git a/input/fsh/Profile-ResearchConsortium.fsh b/input/fsh/Profile-ResearchConsortium.fsh index a4755a72..7a2b0acb 100644 --- a/input/fsh/Profile-ResearchConsortium.fsh +++ b/input/fsh/Profile-ResearchConsortium.fsh @@ -5,5 +5,4 @@ Title: "Research Consortium" Description: "A FHIR Organization representing a single consortium of which one or more NCPI Research Studies is a member" * ^version = "0.1.0" * ^status = #draft -* name 1..1 - +* name 1..1 \ No newline at end of file diff --git a/input/fsh/Profile-ResearchStudySubject.fsh b/input/fsh/Profile-ResearchStudySubject.fsh new file mode 100644 index 00000000..07594d50 --- /dev/null +++ b/input/fsh/Profile-ResearchStudySubject.fsh @@ -0,0 +1,15 @@ +Extension: ResearchStudySubjectConsent +Id: research-study-subject-consent +Title: "Research Study Subject Consent" +Description: "ResearchStudySubjectConsent provides link to a consent through which participants were enrolled." +* value[x] only Reference(ResearchStudyConsent) + +Profile: ResearchStudySubject +Parent: NcpiResearchStudy +Id: research-study-subject +Title: "Research Study Subject" +Description: "A ResearchStudySubject is representative of a group of participants whose consent and data use is governed by the same restrictions." +* ^version = "0.1.0" +* ^status = #draft +* partOf 1..1 +* extension contains ResearchStudySubjectConsent named consent 1..1 \ No newline at end of file diff --git a/input/fsh/ValueSet-NcpiConsentCodes.fsh b/input/fsh/ValueSet-NcpiConsentCodes.fsh new file mode 100644 index 00000000..8ae1c022 --- /dev/null +++ b/input/fsh/ValueSet-NcpiConsentCodes.fsh @@ -0,0 +1,6 @@ +ValueSet: NihConsentCodes +Id: nih-consent-codes +Title: "NIH Consent Code ValueSet" +Description: "List of Abbreviations and titles associated with core NIH Consent types" +* ^status = #draft +* include codes from system $nihcc diff --git a/input/resources/StructureDefinition-research-study-consent.json b/input/resources/StructureDefinition-research-study-consent.json new file mode 100644 index 00000000..68bb4c26 --- /dev/null +++ b/input/resources/StructureDefinition-research-study-consent.json @@ -0,0 +1,2217 @@ +{ + "resourceType" : "StructureDefinition", + "id" : "research-study-consent", + "text" : { + "status" : "extensions", + "div" : "
\r\n\r\n\r\n\r\n
NameFlagsCard.TypeDescription & Constraints\"doco\"
\".\"\".\" Consent 0..*ConsentA healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time
\".\"\".\"\".\" Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
\".\"\".\"\".\" diseaseAbbreviation 0..1stringConsent Code Disease Abbreviation
URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-consent-disease-abbreviation
\".\"\".\"\".\" category 1..*CodeableConceptClassification of the consent statement - for indexing/retrieval
Binding: NIH Consent Code ValueSet (extensible)

\"doco\" Documentation for this format
" + }, + "url" : "https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-consent", + "version" : "0.2.0", + "name" : "ResearchStudyConsent", + "title" : "Research Study Consent", + "status" : "draft", + "date" : "2023-06-09T12:35:36-05:00", + "publisher" : "NCPI FHIR Working Group", + "contact" : [{ + "name" : "NCPI FHIR Working Group", + "telecom" : [{ + "system" : "url", + "value" : "https://github.com/nih-ncpi" + }] + }, + { + "name" : "Meen Chul Kim", + "telecom" : [{ + "system" : "email", + "value" : "meenchul@d3b.center", + "use" : "work" + }] + }], + "description" : "A ResearchStudyConsent represents the core NIH Consent properties as they apply when consenting subjects to a research study", + "fhirVersion" : "4.0.1", + "mapping" : [{ + "identity" : "workflow", + "uri" : "http://hl7.org/fhir/workflow", + "name" : "Workflow Pattern" + }, + { + "identity" : "v2", + "uri" : "http://hl7.org/v2", + "name" : "HL7 v2 Mapping" + }, + { + "identity" : "rim", + "uri" : "http://hl7.org/v3", + "name" : "RIM Mapping" + }, + { + "identity" : "w5", + "uri" : "http://hl7.org/fhir/fivews", + "name" : "FiveWs Pattern Mapping" + }], + "kind" : "resource", + "abstract" : false, + "type" : "Consent", + "baseDefinition" : "http://hl7.org/fhir/StructureDefinition/Consent", + "derivation" : "constraint", + "snapshot" : { + "element" : [{ + "id" : "Consent", + "path" : "Consent", + "short" : "A healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time", + "definition" : "A record of a healthcare consumer’s choices, which permits or denies identified recipient(s) or recipient role(s) to perform one or more actions within a given policy context, for specific purposes and periods of time.", + "comment" : "Broadly, there are 3 key areas of consent for patients: Consent around sharing information (aka Privacy Consent Directive - Authorization to Collect, Use, or Disclose information), consent for specific treatment, or kinds of treatment, and general advance care directives.", + "min" : 0, + "max" : "*", + "base" : { + "path" : "Consent", + "min" : 0, + "max" : "*" + }, + "constraint" : [{ + "key" : "dom-2", + "severity" : "error", + "human" : "If the resource is contained in another resource, it SHALL NOT contain nested Resources", + "expression" : "contained.contained.empty()", + "xpath" : "not(parent::f:contained and f:contained)", + "source" : "http://hl7.org/fhir/StructureDefinition/DomainResource" + }, + { + "key" : "dom-3", + "severity" : "error", + "human" : "If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource", + "expression" : "contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()", + "xpath" : "not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))", + "source" : "http://hl7.org/fhir/StructureDefinition/DomainResource" + }, + { + "key" : "dom-4", + "severity" : "error", + "human" : "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated", + "expression" : "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()", + "xpath" : "not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))", + "source" : "http://hl7.org/fhir/StructureDefinition/DomainResource" + }, + { + "key" : "dom-5", + "severity" : "error", + "human" : "If a resource is contained in another resource, it SHALL NOT have a security label", + "expression" : "contained.meta.security.empty()", + "xpath" : "not(exists(f:contained/*/f:meta/f:security))", + "source" : "http://hl7.org/fhir/StructureDefinition/DomainResource" + }, + { + "extension" : [{ + "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice", + "valueBoolean" : true + }, + { + "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation", + "valueMarkdown" : "When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time." + }], + "key" : "dom-6", + "severity" : "warning", + "human" : "A resource should have narrative for robust management", + "expression" : "text.`div`.exists()", + "xpath" : "exists(f:text/h:div)", + "source" : "http://hl7.org/fhir/StructureDefinition/DomainResource" + }, + { + "key" : "ppc-1", + "severity" : "error", + "human" : "Either a Policy or PolicyRule", + "expression" : "policy.exists() or policyRule.exists()", + "xpath" : "exists(f:policy) or exists(f:policyRule)", + "source" : "http://hl7.org/fhir/StructureDefinition/Consent" + }, + { + "key" : "ppc-2", + "severity" : "error", + "human" : "IF Scope=privacy, there must be a patient", + "expression" : "patient.exists() or scope.coding.where(system='something' and code='patient-privacy').exists().not()", + "xpath" : "exists(f:patient) or not(exists(f:scope/f:coding[f:system/@value='something' and f:code/@value='patient-privacy'])))", + "source" : "http://hl7.org/fhir/StructureDefinition/Consent" + }, + { + "key" : "ppc-3", + "severity" : "error", + "human" : "IF Scope=research, there must be a patient", + "expression" : "patient.exists() or scope.coding.where(system='something' and code='research').exists().not()", + "xpath" : "exists(f:patient) or not(exists(f:scope/f:coding[f:system/@value='something' and f:code/@value='research'])))", + "source" : "http://hl7.org/fhir/StructureDefinition/Consent" + }, + { + "key" : "ppc-4", + "severity" : "error", + "human" : "IF Scope=adr, there must be a patient", + "expression" : "patient.exists() or scope.coding.where(system='something' and code='adr').exists().not()", + "xpath" : "exists(f:patient) or not(exists(f:scope/f:coding[f:system/@value='something' and f:code/@value='adr'])))", + "source" : "http://hl7.org/fhir/StructureDefinition/Consent" + }, + { + "key" : "ppc-5", + "severity" : "error", + "human" : "IF Scope=treatment, there must be a patient", + "expression" : "patient.exists() or scope.coding.where(system='something' and code='treatment').exists().not()", + "xpath" : "exists(f:patient) or not(exists(f:scope/f:coding[f:system/@value='something' and f:code/@value='treatment'])))", + "source" : "http://hl7.org/fhir/StructureDefinition/Consent" + }], + "isModifier" : false, + "isSummary" : false, + "mapping" : [{ + "identity" : "rim", + "map" : "Entity. Role, or Act" + }, + { + "identity" : "workflow", + "map" : "Event" + }, + { + "identity" : "v2", + "map" : "CON" + }, + { + "identity" : "rim", + "map" : "FinancialConsent" + }] + }, + { + "id" : "Consent.id", + "path" : "Consent.id", + "short" : "Logical id of this artifact", + "definition" : "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.", + "comment" : "The only time that a resource does not have an id is when it is being submitted to the server using a create operation.", + "min" : 0, + "max" : "1", + "base" : { + "path" : "Resource.id", + "min" : 0, + "max" : "1" + }, + "type" : [{ + "extension" : [{ + "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", + "valueUrl" : "id" + }], + "code" : "http://hl7.org/fhirpath/System.String" + }], + "isModifier" : false, + "isSummary" : true + }, + { + "id" : "Consent.meta", + "path" : "Consent.meta", + "short" : "Metadata about the resource", + "definition" : "The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.", + "min" : 0, + "max" : "1", + "base" : { + "path" : "Resource.meta", + "min" : 0, + "max" : "1" + }, + "type" : [{ + "code" : "Meta" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : true + }, + { + "id" : "Consent.implicitRules", + "path" : "Consent.implicitRules", + "short" : "A set of rules under which this content was created", + "definition" : "A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.", + "comment" : "Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.", + "min" : 0, + "max" : "1", + "base" : { + "path" : "Resource.implicitRules", + "min" : 0, + "max" : "1" + }, + "type" : [{ + "code" : "uri" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : true, + "isModifierReason" : "This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation", + "isSummary" : true + }, + { + "id" : "Consent.language", + "path" : "Consent.language", + "short" : "Language of the resource content", + "definition" : "The base language in which the resource is written.", + "comment" : "Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).", + "min" : 0, + "max" : "1", + "base" : { + "path" : "Resource.language", + "min" : 0, + "max" : "1" + }, + "type" : [{ + "code" : "code" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : false, + "binding" : { + "extension" : [{ + "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet", + "valueCanonical" : "http://hl7.org/fhir/ValueSet/all-languages" + }, + { + "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", + "valueString" : "Language" + }, + { + "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding", + "valueBoolean" : true + }], + "strength" : "preferred", + "description" : "A human language.", + "valueSet" : "http://hl7.org/fhir/ValueSet/languages" + } + }, + { + "id" : "Consent.text", + "path" : "Consent.text", + "short" : "Text summary of the resource, for human interpretation", + "definition" : "A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.", + "comment" : "Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a \"text blob\" or where text is additionally entered raw or narrated and encoded information is added later.", + "alias" : ["narrative", + "html", + "xhtml", + "display"], + "min" : 0, + "max" : "1", + "base" : { + "path" : "DomainResource.text", + "min" : 0, + "max" : "1" + }, + "type" : [{ + "code" : "Narrative" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : false, + "mapping" : [{ + "identity" : "rim", + "map" : "Act.text?" + }] + }, + { + "id" : "Consent.contained", + "path" : "Consent.contained", + "short" : "Contained, inline Resources", + "definition" : "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.", + "comment" : "This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.", + "alias" : ["inline resources", + "anonymous resources", + "contained resources"], + "min" : 0, + "max" : "*", + "base" : { + "path" : "DomainResource.contained", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "Resource" + }], + "isModifier" : false, + "isSummary" : false, + "mapping" : [{ + "identity" : "rim", + "map" : "N/A" + }] + }, + { + "id" : "Consent.extension", + "path" : "Consent.extension", + "slicing" : { + "discriminator" : [{ + "type" : "value", + "path" : "url" + }], + "ordered" : false, + "rules" : "open" + }, + "short" : "Extension", + "definition" : "An Extension", + "min" : 0, + "max" : "*", + "base" : { + "path" : "DomainResource.extension", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "Extension" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }, + { + "key" : "ext-1", + "severity" : "error", + "human" : "Must have either extensions or value[x], not both", + "expression" : "extension.exists() != value.exists()", + "xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])", + "source" : "http://hl7.org/fhir/StructureDefinition/Extension" + }], + "isModifier" : false, + "isSummary" : false + }, + { + "id" : "Consent.extension:diseaseAbbreviation", + "path" : "Consent.extension", + "sliceName" : "diseaseAbbreviation", + "short" : "Consent Code Disease Abbreviation", + "definition" : "Full code string for disease specific consent abbreviations", + "min" : 0, + "max" : "1", + "base" : { + "path" : "DomainResource.extension", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "Extension", + "profile" : ["https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-consent-disease-abbreviation"] + }], + "condition" : ["ele-1"], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }, + { + "key" : "ext-1", + "severity" : "error", + "human" : "Must have either extensions or value[x], not both", + "expression" : "extension.exists() != value.exists()", + "xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])", + "source" : "http://hl7.org/fhir/StructureDefinition/Extension" + }, + { + "key" : "disease-specific-consent-code", + "severity" : "error", + "human" : "Disease Specific components reflect the content that appears after the DS- portion of the NIH style consent code.", + "expression" : "valueString.matches('DS-[A-Z]+')", + "source" : "https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-consent-disease-abbreviation" + }], + "isModifier" : false + }, + { + "id" : "Consent.modifierExtension", + "path" : "Consent.modifierExtension", + "short" : "Extensions that cannot be ignored", + "definition" : "May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", + "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", + "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).", + "alias" : ["extensions", + "user content"], + "min" : 0, + "max" : "*", + "base" : { + "path" : "DomainResource.modifierExtension", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "Extension" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }, + { + "key" : "ext-1", + "severity" : "error", + "human" : "Must have either extensions or value[x], not both", + "expression" : "extension.exists() != value.exists()", + "xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])", + "source" : "http://hl7.org/fhir/StructureDefinition/Extension" + }], + "isModifier" : true, + "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them", + "isSummary" : false, + "mapping" : [{ + "identity" : "rim", + "map" : "N/A" + }] + }, + { + "id" : "Consent.identifier", + "path" : "Consent.identifier", + "short" : "Identifier for this record (external references)", + "definition" : "Unique identifier for this copy of the Consent Statement.", + "comment" : "This identifier identifies this copy of the consent. Where this identifier is also used elsewhere as the identifier for a consent record (e.g. a CDA consent document) then the consent details are expected to be the same.", + "min" : 0, + "max" : "*", + "base" : { + "path" : "Consent.identifier", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "Identifier" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : true, + "mapping" : [{ + "identity" : "workflow", + "map" : "Event.identifier" + }, + { + "identity" : "w5", + "map" : "FiveWs.identifier" + }, + { + "identity" : "rim", + "map" : ".id" + }] + }, + { + "id" : "Consent.status", + "path" : "Consent.status", + "short" : "draft | proposed | active | rejected | inactive | entered-in-error", + "definition" : "Indicates the current state of this consent.", + "comment" : "This element is labeled as a modifier because the status contains the codes rejected and entered-in-error that mark the Consent as not currently valid.", + "requirements" : "The Consent Directive that is pointed to might be in various lifecycle states, e.g., a revoked Consent Directive.", + "min" : 1, + "max" : "1", + "base" : { + "path" : "Consent.status", + "min" : 1, + "max" : "1" + }, + "type" : [{ + "code" : "code" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : true, + "isModifierReason" : "This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid", + "isSummary" : true, + "binding" : { + "extension" : [{ + "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", + "valueString" : "ConsentState" + }], + "strength" : "required", + "description" : "Indicates the state of the consent.", + "valueSet" : "http://hl7.org/fhir/ValueSet/consent-state-codes|4.0.1" + }, + "mapping" : [{ + "identity" : "workflow", + "map" : "Event.status" + }, + { + "identity" : "w5", + "map" : "FiveWs.status" + }, + { + "identity" : "v2", + "map" : "HL7 Table 0498 - Consent Status" + }, + { + "identity" : "rim", + "map" : ".statusCode" + }] + }, + { + "id" : "Consent.scope", + "path" : "Consent.scope", + "short" : "Which of the four areas this resource covers (extensible)", + "definition" : "A selector of the type of consent being presented: ADR, Privacy, Treatment, Research. This list is now extensible.", + "min" : 1, + "max" : "1", + "base" : { + "path" : "Consent.scope", + "min" : 1, + "max" : "1" + }, + "type" : [{ + "code" : "CodeableConcept" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : true, + "isModifierReason" : "Allows changes to codes based on scope selection", + "isSummary" : true, + "binding" : { + "extension" : [{ + "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", + "valueString" : "ConsentScope" + }], + "strength" : "extensible", + "description" : "The four anticipated uses for the Consent Resource.", + "valueSet" : "http://hl7.org/fhir/ValueSet/consent-scope" + } + }, + { + "id" : "Consent.category", + "path" : "Consent.category", + "short" : "Classification of the consent statement - for indexing/retrieval", + "definition" : "A classification of the type of consents found in the statement. This element supports indexing and retrieval of consent statements.", + "min" : 1, + "max" : "*", + "base" : { + "path" : "Consent.category", + "min" : 1, + "max" : "*" + }, + "type" : [{ + "code" : "CodeableConcept" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : true, + "binding" : { + "strength" : "extensible", + "valueSet" : "https://nih-ncpi.github.io/ncpi-fhir-ig/ValueSet/nih-consent-codes" + }, + "mapping" : [{ + "identity" : "workflow", + "map" : "Event.code" + }, + { + "identity" : "w5", + "map" : "FiveWs.class" + }, + { + "identity" : "v2", + "map" : "HL7 Table 0497 - Consent Type" + }, + { + "identity" : "rim", + "map" : "CNTRCT" + }] + }, + { + "id" : "Consent.patient", + "path" : "Consent.patient", + "short" : "Who the consent applies to", + "definition" : "The patient/healthcare consumer to whom this consent applies.", + "comment" : "Commonly, the patient the consent pertains to is the author, but for young and old people, it may be some other person.", + "min" : 0, + "max" : "1", + "base" : { + "path" : "Consent.patient", + "min" : 0, + "max" : "1" + }, + "type" : [{ + "code" : "Reference", + "targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Patient"] + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : true, + "mapping" : [{ + "identity" : "workflow", + "map" : "Event.subject" + }, + { + "identity" : "w5", + "map" : "FiveWs.subject[x]" + }, + { + "identity" : "rim", + "map" : "Role" + }, + { + "identity" : "w5", + "map" : "FiveWs.subject" + }] + }, + { + "id" : "Consent.dateTime", + "path" : "Consent.dateTime", + "short" : "When this Consent was created or indexed", + "definition" : "When this Consent was issued / created / indexed.", + "comment" : "This is not the time of the original consent, but the time that this statement was made or derived.", + "min" : 0, + "max" : "1", + "base" : { + "path" : "Consent.dateTime", + "min" : 0, + "max" : "1" + }, + "type" : [{ + "code" : "dateTime" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : true, + "mapping" : [{ + "identity" : "workflow", + "map" : "Event.occurrence[x]" + }, + { + "identity" : "w5", + "map" : "FiveWs.recorded" + }, + { + "identity" : "v2", + "map" : "Field 13/ Consent Decision Date" + }, + { + "identity" : "rim", + "map" : "FinancialConsent effectiveTime" + }] + }, + { + "id" : "Consent.performer", + "path" : "Consent.performer", + "short" : "Who is agreeing to the policy and rules", + "definition" : "Either the Grantor, which is the entity responsible for granting the rights listed in a Consent Directive or the Grantee, which is the entity responsible for complying with the Consent Directive, including any obligations or limitations on authorizations and enforcement of prohibitions.", + "comment" : "Commonly, the patient the consent pertains to is the consentor, but particularly for young and old people, it may be some other person - e.g. a legal guardian.", + "alias" : ["consentor"], + "min" : 0, + "max" : "*", + "base" : { + "path" : "Consent.performer", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "Reference", + "targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Organization", + "http://hl7.org/fhir/StructureDefinition/Patient", + "http://hl7.org/fhir/StructureDefinition/Practitioner", + "http://hl7.org/fhir/StructureDefinition/RelatedPerson", + "http://hl7.org/fhir/StructureDefinition/PractitionerRole"] + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : true, + "mapping" : [{ + "identity" : "workflow", + "map" : "Event.performer" + }, + { + "identity" : "w5", + "map" : "FiveWs.actor" + }, + { + "identity" : "v2", + "map" : "Field 24/ ConsenterID" + }] + }, + { + "id" : "Consent.organization", + "path" : "Consent.organization", + "short" : "Custodian of the consent", + "definition" : "The organization that manages the consent, and the framework within which it is executed.", + "alias" : ["custodian"], + "min" : 0, + "max" : "*", + "base" : { + "path" : "Consent.organization", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "Reference", + "targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Organization"] + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : true, + "mapping" : [{ + "identity" : "workflow", + "map" : "Event.performer" + }, + { + "identity" : "w5", + "map" : "FiveWs.witness" + }] + }, + { + "id" : "Consent.source[x]", + "path" : "Consent.source[x]", + "short" : "Source from which this consent is taken", + "definition" : "The source on which this consent statement is based. The source might be a scanned original paper form, or a reference to a consent that links back to such a source, a reference to a document repository (e.g. XDS) that stores the original consent document.", + "comment" : "The source can be contained inline (Attachment), referenced directly (Consent), referenced in a consent repository (DocumentReference), or simply by an identifier (Identifier), e.g. a CDA document id.", + "min" : 0, + "max" : "1", + "base" : { + "path" : "Consent.source[x]", + "min" : 0, + "max" : "1" + }, + "type" : [{ + "code" : "Attachment" + }, + { + "code" : "Reference", + "targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Consent", + "http://hl7.org/fhir/StructureDefinition/DocumentReference", + "http://hl7.org/fhir/StructureDefinition/Contract", + "http://hl7.org/fhir/StructureDefinition/QuestionnaireResponse"] + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : true, + "mapping" : [{ + "identity" : "v2", + "map" : "Field 19 Informational Material Supplied Indicator" + }] + }, + { + "id" : "Consent.policy", + "path" : "Consent.policy", + "short" : "Policies covered by this consent", + "definition" : "The references to the policies that are included in this consent scope. Policies may be organizational, but are often defined jurisdictionally, or in law.", + "min" : 0, + "max" : "*", + "base" : { + "path" : "Consent.policy", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "BackboneElement" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : false + }, + { + "id" : "Consent.policy.id", + "path" : "Consent.policy.id", + "representation" : ["xmlAttr"], + "short" : "Unique id for inter-element referencing", + "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", + "min" : 0, + "max" : "1", + "base" : { + "path" : "Element.id", + "min" : 0, + "max" : "1" + }, + "type" : [{ + "extension" : [{ + "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", + "valueUrl" : "string" + }], + "code" : "http://hl7.org/fhirpath/System.String" + }], + "isModifier" : false, + "isSummary" : false, + "mapping" : [{ + "identity" : "rim", + "map" : "n/a" + }] + }, + { + "id" : "Consent.policy.extension", + "path" : "Consent.policy.extension", + "short" : "Additional content defined by implementations", + "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", + "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", + "alias" : ["extensions", + "user content"], + "min" : 0, + "max" : "*", + "base" : { + "path" : "Element.extension", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "Extension" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }, + { + "key" : "ext-1", + "severity" : "error", + "human" : "Must have either extensions or value[x], not both", + "expression" : "extension.exists() != value.exists()", + "xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])", + "source" : "http://hl7.org/fhir/StructureDefinition/Extension" + }], + "isModifier" : false, + "isSummary" : false, + "mapping" : [{ + "identity" : "rim", + "map" : "n/a" + }] + }, + { + "id" : "Consent.policy.modifierExtension", + "path" : "Consent.policy.modifierExtension", + "short" : "Extensions that cannot be ignored even if unrecognized", + "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", + "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", + "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).", + "alias" : ["extensions", + "user content", + "modifiers"], + "min" : 0, + "max" : "*", + "base" : { + "path" : "BackboneElement.modifierExtension", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "Extension" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }, + { + "key" : "ext-1", + "severity" : "error", + "human" : "Must have either extensions or value[x], not both", + "expression" : "extension.exists() != value.exists()", + "xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])", + "source" : "http://hl7.org/fhir/StructureDefinition/Extension" + }], + "isModifier" : true, + "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", + "isSummary" : true, + "mapping" : [{ + "identity" : "rim", + "map" : "N/A" + }] + }, + { + "id" : "Consent.policy.authority", + "path" : "Consent.policy.authority", + "short" : "Enforcement source for policy", + "definition" : "Entity or Organization having regulatory jurisdiction or accountability for enforcing policies pertaining to Consent Directives.", + "min" : 0, + "max" : "1", + "base" : { + "path" : "Consent.policy.authority", + "min" : 0, + "max" : "1" + }, + "type" : [{ + "code" : "uri" + }], + "condition" : ["ppc-1"], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : false + }, + { + "id" : "Consent.policy.uri", + "path" : "Consent.policy.uri", + "short" : "Specific policy covered by this consent", + "definition" : "The references to the policies that are included in this consent scope. Policies may be organizational, but are often defined jurisdictionally, or in law.", + "comment" : "This element is for discoverability / documentation and does not modify or qualify the policy rules.", + "min" : 0, + "max" : "1", + "base" : { + "path" : "Consent.policy.uri", + "min" : 0, + "max" : "1" + }, + "type" : [{ + "code" : "uri" + }], + "condition" : ["ppc-1"], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : false + }, + { + "id" : "Consent.policyRule", + "path" : "Consent.policyRule", + "short" : "Regulation that this consents to", + "definition" : "A reference to the specific base computable regulation or policy.", + "comment" : "If the policyRule is absent, computable consent would need to be constructed from the elements of the Consent resource.", + "requirements" : "Might be a unique identifier of a policy set in XACML, or other rules engine.", + "min" : 0, + "max" : "1", + "base" : { + "path" : "Consent.policyRule", + "min" : 0, + "max" : "1" + }, + "type" : [{ + "code" : "CodeableConcept" + }], + "condition" : ["ppc-1"], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : true, + "binding" : { + "extension" : [{ + "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", + "valueString" : "ConsentPolicyRule" + }], + "strength" : "extensible", + "description" : "Regulatory policy examples.", + "valueSet" : "http://hl7.org/fhir/ValueSet/consent-policy" + } + }, + { + "id" : "Consent.verification", + "path" : "Consent.verification", + "short" : "Consent Verified by patient or family", + "definition" : "Whether a treatment instruction (e.g. artificial respiration yes or no) was verified with the patient, his/her family or another authorized person.", + "min" : 0, + "max" : "*", + "base" : { + "path" : "Consent.verification", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "BackboneElement" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : true + }, + { + "id" : "Consent.verification.id", + "path" : "Consent.verification.id", + "representation" : ["xmlAttr"], + "short" : "Unique id for inter-element referencing", + "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", + "min" : 0, + "max" : "1", + "base" : { + "path" : "Element.id", + "min" : 0, + "max" : "1" + }, + "type" : [{ + "extension" : [{ + "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", + "valueUrl" : "string" + }], + "code" : "http://hl7.org/fhirpath/System.String" + }], + "isModifier" : false, + "isSummary" : false, + "mapping" : [{ + "identity" : "rim", + "map" : "n/a" + }] + }, + { + "id" : "Consent.verification.extension", + "path" : "Consent.verification.extension", + "short" : "Additional content defined by implementations", + "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", + "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", + "alias" : ["extensions", + "user content"], + "min" : 0, + "max" : "*", + "base" : { + "path" : "Element.extension", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "Extension" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }, + { + "key" : "ext-1", + "severity" : "error", + "human" : "Must have either extensions or value[x], not both", + "expression" : "extension.exists() != value.exists()", + "xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])", + "source" : "http://hl7.org/fhir/StructureDefinition/Extension" + }], + "isModifier" : false, + "isSummary" : false, + "mapping" : [{ + "identity" : "rim", + "map" : "n/a" + }] + }, + { + "id" : "Consent.verification.modifierExtension", + "path" : "Consent.verification.modifierExtension", + "short" : "Extensions that cannot be ignored even if unrecognized", + "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", + "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", + "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).", + "alias" : ["extensions", + "user content", + "modifiers"], + "min" : 0, + "max" : "*", + "base" : { + "path" : "BackboneElement.modifierExtension", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "Extension" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }, + { + "key" : "ext-1", + "severity" : "error", + "human" : "Must have either extensions or value[x], not both", + "expression" : "extension.exists() != value.exists()", + "xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])", + "source" : "http://hl7.org/fhir/StructureDefinition/Extension" + }], + "isModifier" : true, + "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", + "isSummary" : true, + "mapping" : [{ + "identity" : "rim", + "map" : "N/A" + }] + }, + { + "id" : "Consent.verification.verified", + "path" : "Consent.verification.verified", + "short" : "Has been verified", + "definition" : "Has the instruction been verified.", + "min" : 1, + "max" : "1", + "base" : { + "path" : "Consent.verification.verified", + "min" : 1, + "max" : "1" + }, + "type" : [{ + "code" : "boolean" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : true + }, + { + "id" : "Consent.verification.verifiedWith", + "path" : "Consent.verification.verifiedWith", + "short" : "Person who verified", + "definition" : "Who verified the instruction (Patient, Relative or other Authorized Person).", + "min" : 0, + "max" : "1", + "base" : { + "path" : "Consent.verification.verifiedWith", + "min" : 0, + "max" : "1" + }, + "type" : [{ + "code" : "Reference", + "targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Patient", + "http://hl7.org/fhir/StructureDefinition/RelatedPerson"] + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : false + }, + { + "id" : "Consent.verification.verificationDate", + "path" : "Consent.verification.verificationDate", + "short" : "When consent verified", + "definition" : "Date verification was collected.", + "min" : 0, + "max" : "1", + "base" : { + "path" : "Consent.verification.verificationDate", + "min" : 0, + "max" : "1" + }, + "type" : [{ + "code" : "dateTime" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : false + }, + { + "id" : "Consent.provision", + "extension" : [{ + "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-explicit-type-name", + "valueString" : "provision" + }], + "path" : "Consent.provision", + "short" : "Constraints to the base Consent.policyRule", + "definition" : "An exception to the base policy of this consent. An exception can be an addition or removal of access permissions.", + "min" : 0, + "max" : "1", + "base" : { + "path" : "Consent.provision", + "min" : 0, + "max" : "1" + }, + "type" : [{ + "code" : "BackboneElement" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : true + }, + { + "id" : "Consent.provision.id", + "path" : "Consent.provision.id", + "representation" : ["xmlAttr"], + "short" : "Unique id for inter-element referencing", + "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", + "min" : 0, + "max" : "1", + "base" : { + "path" : "Element.id", + "min" : 0, + "max" : "1" + }, + "type" : [{ + "extension" : [{ + "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", + "valueUrl" : "string" + }], + "code" : "http://hl7.org/fhirpath/System.String" + }], + "isModifier" : false, + "isSummary" : false, + "mapping" : [{ + "identity" : "rim", + "map" : "n/a" + }] + }, + { + "id" : "Consent.provision.extension", + "path" : "Consent.provision.extension", + "short" : "Additional content defined by implementations", + "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", + "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", + "alias" : ["extensions", + "user content"], + "min" : 0, + "max" : "*", + "base" : { + "path" : "Element.extension", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "Extension" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }, + { + "key" : "ext-1", + "severity" : "error", + "human" : "Must have either extensions or value[x], not both", + "expression" : "extension.exists() != value.exists()", + "xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])", + "source" : "http://hl7.org/fhir/StructureDefinition/Extension" + }], + "isModifier" : false, + "isSummary" : false, + "mapping" : [{ + "identity" : "rim", + "map" : "n/a" + }] + }, + { + "id" : "Consent.provision.modifierExtension", + "path" : "Consent.provision.modifierExtension", + "short" : "Extensions that cannot be ignored even if unrecognized", + "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", + "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", + "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).", + "alias" : ["extensions", + "user content", + "modifiers"], + "min" : 0, + "max" : "*", + "base" : { + "path" : "BackboneElement.modifierExtension", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "Extension" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }, + { + "key" : "ext-1", + "severity" : "error", + "human" : "Must have either extensions or value[x], not both", + "expression" : "extension.exists() != value.exists()", + "xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])", + "source" : "http://hl7.org/fhir/StructureDefinition/Extension" + }], + "isModifier" : true, + "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", + "isSummary" : true, + "mapping" : [{ + "identity" : "rim", + "map" : "N/A" + }] + }, + { + "id" : "Consent.provision.type", + "path" : "Consent.provision.type", + "short" : "deny | permit", + "definition" : "Action to take - permit or deny - when the rule conditions are met. Not permitted in root rule, required in all nested rules.", + "min" : 0, + "max" : "1", + "base" : { + "path" : "Consent.provision.type", + "min" : 0, + "max" : "1" + }, + "type" : [{ + "code" : "code" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : true, + "binding" : { + "extension" : [{ + "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", + "valueString" : "ConsentProvisionType" + }], + "strength" : "required", + "description" : "How a rule statement is applied, such as adding additional consent or removing consent.", + "valueSet" : "http://hl7.org/fhir/ValueSet/consent-provision-type|4.0.1" + } + }, + { + "id" : "Consent.provision.period", + "path" : "Consent.provision.period", + "short" : "Timeframe for this rule", + "definition" : "The timeframe in this rule is valid.", + "min" : 0, + "max" : "1", + "base" : { + "path" : "Consent.provision.period", + "min" : 0, + "max" : "1" + }, + "type" : [{ + "code" : "Period" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : true + }, + { + "id" : "Consent.provision.actor", + "extension" : [{ + "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-explicit-type-name", + "valueString" : "provisionActor" + }], + "path" : "Consent.provision.actor", + "short" : "Who|what controlled by this rule (or group, by role)", + "definition" : "Who or what is controlled by this rule. Use group to identify a set of actors by some property they share (e.g. 'admitting officers').", + "min" : 0, + "max" : "*", + "base" : { + "path" : "Consent.provision.actor", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "BackboneElement" + }], + "meaningWhenMissing" : "There is no specific actor associated with the exception", + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : false + }, + { + "id" : "Consent.provision.actor.id", + "path" : "Consent.provision.actor.id", + "representation" : ["xmlAttr"], + "short" : "Unique id for inter-element referencing", + "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", + "min" : 0, + "max" : "1", + "base" : { + "path" : "Element.id", + "min" : 0, + "max" : "1" + }, + "type" : [{ + "extension" : [{ + "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", + "valueUrl" : "string" + }], + "code" : "http://hl7.org/fhirpath/System.String" + }], + "isModifier" : false, + "isSummary" : false, + "mapping" : [{ + "identity" : "rim", + "map" : "n/a" + }] + }, + { + "id" : "Consent.provision.actor.extension", + "path" : "Consent.provision.actor.extension", + "short" : "Additional content defined by implementations", + "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", + "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", + "alias" : ["extensions", + "user content"], + "min" : 0, + "max" : "*", + "base" : { + "path" : "Element.extension", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "Extension" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }, + { + "key" : "ext-1", + "severity" : "error", + "human" : "Must have either extensions or value[x], not both", + "expression" : "extension.exists() != value.exists()", + "xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])", + "source" : "http://hl7.org/fhir/StructureDefinition/Extension" + }], + "isModifier" : false, + "isSummary" : false, + "mapping" : [{ + "identity" : "rim", + "map" : "n/a" + }] + }, + { + "id" : "Consent.provision.actor.modifierExtension", + "path" : "Consent.provision.actor.modifierExtension", + "short" : "Extensions that cannot be ignored even if unrecognized", + "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", + "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", + "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).", + "alias" : ["extensions", + "user content", + "modifiers"], + "min" : 0, + "max" : "*", + "base" : { + "path" : "BackboneElement.modifierExtension", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "Extension" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }, + { + "key" : "ext-1", + "severity" : "error", + "human" : "Must have either extensions or value[x], not both", + "expression" : "extension.exists() != value.exists()", + "xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])", + "source" : "http://hl7.org/fhir/StructureDefinition/Extension" + }], + "isModifier" : true, + "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", + "isSummary" : true, + "mapping" : [{ + "identity" : "rim", + "map" : "N/A" + }] + }, + { + "id" : "Consent.provision.actor.role", + "path" : "Consent.provision.actor.role", + "short" : "How the actor is involved", + "definition" : "How the individual is involved in the resources content that is described in the exception.", + "min" : 1, + "max" : "1", + "base" : { + "path" : "Consent.provision.actor.role", + "min" : 1, + "max" : "1" + }, + "type" : [{ + "code" : "CodeableConcept" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : false, + "binding" : { + "extension" : [{ + "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", + "valueString" : "ConsentActorRole" + }], + "strength" : "extensible", + "description" : "How an actor is involved in the consent considerations.", + "valueSet" : "http://hl7.org/fhir/ValueSet/security-role-type" + } + }, + { + "id" : "Consent.provision.actor.reference", + "path" : "Consent.provision.actor.reference", + "short" : "Resource for the actor (or group, by role)", + "definition" : "The resource that identifies the actor. To identify actors by type, use group to identify a set of actors by some property they share (e.g. 'admitting officers').", + "min" : 1, + "max" : "1", + "base" : { + "path" : "Consent.provision.actor.reference", + "min" : 1, + "max" : "1" + }, + "type" : [{ + "code" : "Reference", + "targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Device", + "http://hl7.org/fhir/StructureDefinition/Group", + "http://hl7.org/fhir/StructureDefinition/CareTeam", + "http://hl7.org/fhir/StructureDefinition/Organization", + "http://hl7.org/fhir/StructureDefinition/Patient", + "http://hl7.org/fhir/StructureDefinition/Practitioner", + "http://hl7.org/fhir/StructureDefinition/RelatedPerson", + "http://hl7.org/fhir/StructureDefinition/PractitionerRole"] + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : false + }, + { + "id" : "Consent.provision.action", + "path" : "Consent.provision.action", + "short" : "Actions controlled by this rule", + "definition" : "Actions controlled by this Rule.", + "comment" : "Note that this is the direct action (not the grounds for the action covered in the purpose element). At present, the only action in the understood and tested scope of this resource is 'read'.", + "min" : 0, + "max" : "*", + "base" : { + "path" : "Consent.provision.action", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "CodeableConcept" + }], + "meaningWhenMissing" : "all actions", + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : true, + "binding" : { + "extension" : [{ + "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", + "valueString" : "ConsentAction" + }], + "strength" : "example", + "description" : "Detailed codes for the consent action.", + "valueSet" : "http://hl7.org/fhir/ValueSet/consent-action" + } + }, + { + "id" : "Consent.provision.securityLabel", + "path" : "Consent.provision.securityLabel", + "short" : "Security Labels that define affected resources", + "definition" : "A security label, comprised of 0..* security label fields (Privacy tags), which define which resources are controlled by this exception.", + "comment" : "If the consent specifies a security label of \"R\" then it applies to all resources that are labeled \"R\" or lower. E.g. for Confidentiality, it's a high water mark. For other kinds of security labels, subsumption logic applies. When the purpose of use tag is on the data, access request purpose of use shall not conflict.", + "min" : 0, + "max" : "*", + "base" : { + "path" : "Consent.provision.securityLabel", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "Coding" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : true, + "binding" : { + "extension" : [{ + "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", + "valueString" : "SecurityLabels" + }, + { + "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding", + "valueBoolean" : true + }], + "strength" : "extensible", + "description" : "Security Labels from the Healthcare Privacy and Security Classification System.", + "valueSet" : "http://hl7.org/fhir/ValueSet/security-labels" + } + }, + { + "id" : "Consent.provision.purpose", + "path" : "Consent.provision.purpose", + "short" : "Context of activities covered by this rule", + "definition" : "The context of the activities a user is taking - why the user is accessing the data - that are controlled by this rule.", + "comment" : "When the purpose of use tag is on the data, access request purpose of use shall not conflict.", + "min" : 0, + "max" : "*", + "base" : { + "path" : "Consent.provision.purpose", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "Coding" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : true, + "binding" : { + "extension" : [{ + "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", + "valueString" : "PurposeOfUse" + }], + "strength" : "extensible", + "description" : "What purposes of use are controlled by this exception. If more than one label is specified, operations must have all the specified labels.", + "valueSet" : "http://terminology.hl7.org/ValueSet/v3-PurposeOfUse" + } + }, + { + "id" : "Consent.provision.class", + "path" : "Consent.provision.class", + "short" : "e.g. Resource Type, Profile, CDA, etc.", + "definition" : "The class of information covered by this rule. The type can be a FHIR resource type, a profile on a type, or a CDA document, or some other type that indicates what sort of information the consent relates to.", + "comment" : "Multiple types are or'ed together. The intention of the contentType element is that the codes refer to profiles or document types defined in a standard or an implementation guide somewhere.", + "min" : 0, + "max" : "*", + "base" : { + "path" : "Consent.provision.class", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "Coding" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : true, + "binding" : { + "extension" : [{ + "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", + "valueString" : "ConsentContentClass" + }], + "strength" : "extensible", + "description" : "The class (type) of information a consent rule covers.", + "valueSet" : "http://hl7.org/fhir/ValueSet/consent-content-class" + } + }, + { + "id" : "Consent.provision.code", + "path" : "Consent.provision.code", + "short" : "e.g. LOINC or SNOMED CT code, etc. in the content", + "definition" : "If this code is found in an instance, then the rule applies.", + "comment" : "Typical use of this is a Document code with class = CDA.", + "min" : 0, + "max" : "*", + "base" : { + "path" : "Consent.provision.code", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "CodeableConcept" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : true, + "binding" : { + "extension" : [{ + "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", + "valueString" : "ConsentContentCode" + }], + "strength" : "example", + "description" : "If this code is found in an instance, then the exception applies.", + "valueSet" : "http://hl7.org/fhir/ValueSet/consent-content-code" + } + }, + { + "id" : "Consent.provision.dataPeriod", + "path" : "Consent.provision.dataPeriod", + "short" : "Timeframe for data controlled by this rule", + "definition" : "Clinical or Operational Relevant period of time that bounds the data controlled by this rule.", + "comment" : "This has a different sense to the Consent.period - that is when the consent agreement holds. This is the time period of the data that is controlled by the agreement.", + "min" : 0, + "max" : "1", + "base" : { + "path" : "Consent.provision.dataPeriod", + "min" : 0, + "max" : "1" + }, + "type" : [{ + "code" : "Period" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : true + }, + { + "id" : "Consent.provision.data", + "extension" : [{ + "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-explicit-type-name", + "valueString" : "provisionData" + }], + "path" : "Consent.provision.data", + "short" : "Data controlled by this rule", + "definition" : "The resources controlled by this rule if specific resources are referenced.", + "min" : 0, + "max" : "*", + "base" : { + "path" : "Consent.provision.data", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "BackboneElement" + }], + "meaningWhenMissing" : "all data", + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : true, + "mapping" : [{ + "identity" : "rim", + "map" : "Role" + }] + }, + { + "id" : "Consent.provision.data.id", + "path" : "Consent.provision.data.id", + "representation" : ["xmlAttr"], + "short" : "Unique id for inter-element referencing", + "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", + "min" : 0, + "max" : "1", + "base" : { + "path" : "Element.id", + "min" : 0, + "max" : "1" + }, + "type" : [{ + "extension" : [{ + "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", + "valueUrl" : "string" + }], + "code" : "http://hl7.org/fhirpath/System.String" + }], + "isModifier" : false, + "isSummary" : false, + "mapping" : [{ + "identity" : "rim", + "map" : "n/a" + }] + }, + { + "id" : "Consent.provision.data.extension", + "path" : "Consent.provision.data.extension", + "short" : "Additional content defined by implementations", + "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", + "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", + "alias" : ["extensions", + "user content"], + "min" : 0, + "max" : "*", + "base" : { + "path" : "Element.extension", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "Extension" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }, + { + "key" : "ext-1", + "severity" : "error", + "human" : "Must have either extensions or value[x], not both", + "expression" : "extension.exists() != value.exists()", + "xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])", + "source" : "http://hl7.org/fhir/StructureDefinition/Extension" + }], + "isModifier" : false, + "isSummary" : false, + "mapping" : [{ + "identity" : "rim", + "map" : "n/a" + }] + }, + { + "id" : "Consent.provision.data.modifierExtension", + "path" : "Consent.provision.data.modifierExtension", + "short" : "Extensions that cannot be ignored even if unrecognized", + "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", + "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", + "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).", + "alias" : ["extensions", + "user content", + "modifiers"], + "min" : 0, + "max" : "*", + "base" : { + "path" : "BackboneElement.modifierExtension", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "Extension" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }, + { + "key" : "ext-1", + "severity" : "error", + "human" : "Must have either extensions or value[x], not both", + "expression" : "extension.exists() != value.exists()", + "xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])", + "source" : "http://hl7.org/fhir/StructureDefinition/Extension" + }], + "isModifier" : true, + "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", + "isSummary" : true, + "mapping" : [{ + "identity" : "rim", + "map" : "N/A" + }] + }, + { + "id" : "Consent.provision.data.meaning", + "path" : "Consent.provision.data.meaning", + "short" : "instance | related | dependents | authoredby", + "definition" : "How the resource reference is interpreted when testing consent restrictions.", + "min" : 1, + "max" : "1", + "base" : { + "path" : "Consent.provision.data.meaning", + "min" : 1, + "max" : "1" + }, + "type" : [{ + "code" : "code" + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : true, + "binding" : { + "extension" : [{ + "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", + "valueString" : "ConsentDataMeaning" + }], + "strength" : "required", + "description" : "How a resource reference is interpreted when testing consent restrictions.", + "valueSet" : "http://hl7.org/fhir/ValueSet/consent-data-meaning|4.0.1" + } + }, + { + "id" : "Consent.provision.data.reference", + "path" : "Consent.provision.data.reference", + "short" : "The actual data reference", + "definition" : "A reference to a specific resource that defines which resources are covered by this consent.", + "min" : 1, + "max" : "1", + "base" : { + "path" : "Consent.provision.data.reference", + "min" : 1, + "max" : "1" + }, + "type" : [{ + "code" : "Reference", + "targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Resource"] + }], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : true + }, + { + "id" : "Consent.provision.provision", + "path" : "Consent.provision.provision", + "short" : "Nested Exception Rules", + "definition" : "Rules which provide exceptions to the base rule or subrules.", + "min" : 0, + "max" : "*", + "base" : { + "path" : "Consent.provision.provision", + "min" : 0, + "max" : "*" + }, + "contentReference" : "http://hl7.org/fhir/StructureDefinition/Consent#Consent.provision", + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }], + "isModifier" : false, + "isSummary" : false + }] + }, + "differential" : { + "element" : [{ + "id" : "Consent", + "path" : "Consent" + }, + { + "id" : "Consent.extension", + "path" : "Consent.extension", + "slicing" : { + "discriminator" : [{ + "type" : "value", + "path" : "url" + }], + "ordered" : false, + "rules" : "open" + } + }, + { + "id" : "Consent.extension:diseaseAbbreviation", + "path" : "Consent.extension", + "sliceName" : "diseaseAbbreviation", + "short" : "Consent Code Disease Abbreviation", + "min" : 0, + "max" : "1", + "type" : [{ + "code" : "Extension", + "profile" : ["https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-consent-disease-abbreviation"] + }] + }, + { + "id" : "Consent.category", + "path" : "Consent.category", + "binding" : { + "strength" : "extensible", + "valueSet" : "https://nih-ncpi.github.io/ncpi-fhir-ig/ValueSet/nih-consent-codes" + } + }] + } +} From 748f9a75b8f00bbce3ca4d5060edf9005ec0ecaa Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Fri, 9 Jun 2023 17:03:05 -0500 Subject: [PATCH 05/50] Update continuous_integration.yml --- .github/workflows/continuous_integration.yml | 2 +- 1 file changed, 1 insertion(+), 1 deletion(-) diff --git a/.github/workflows/continuous_integration.yml b/.github/workflows/continuous_integration.yml index ccd61590..dc798c57 100644 --- a/.github/workflows/continuous_integration.yml +++ b/.github/workflows/continuous_integration.yml @@ -11,7 +11,7 @@ jobs: runs-on: ubuntu-20.04 strategy: matrix: - node-version: [10, 12] + node-version: [10, 12, 14, 16] steps: - name: Check out branch uses: actions/checkout@v2 From 9a9b28a4144c268921b1a82d1785a94ccd2a12cf Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 12 Jun 2023 09:26:35 -0500 Subject: [PATCH 06/50] Update continuous_integration.yml node 12 seems to be deprecated --- .github/workflows/continuous_integration.yml | 2 +- 1 file changed, 1 insertion(+), 1 deletion(-) diff --git a/.github/workflows/continuous_integration.yml b/.github/workflows/continuous_integration.yml index dc798c57..7ce14efd 100644 --- a/.github/workflows/continuous_integration.yml +++ b/.github/workflows/continuous_integration.yml @@ -11,7 +11,7 @@ jobs: runs-on: ubuntu-20.04 strategy: matrix: - node-version: [10, 12, 14, 16] + node-version: [14, 16] steps: - name: Check out branch uses: actions/checkout@v2 From 90b0daff90940ccc4320e9526a7b77837dc64876 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 12 Jun 2023 09:31:36 -0500 Subject: [PATCH 07/50] Update continuous_integration.yml Attempting to update gems to prevent the jeckyll install error --- .github/workflows/continuous_integration.yml | 2 ++ 1 file changed, 2 insertions(+) diff --git a/.github/workflows/continuous_integration.yml b/.github/workflows/continuous_integration.yml index 7ce14efd..9e459c42 100644 --- a/.github/workflows/continuous_integration.yml +++ b/.github/workflows/continuous_integration.yml @@ -25,6 +25,8 @@ jobs: run: | sudo apt-get update sudo apt-get -y install ruby-full build-essential zlib1g-dev + sudo gem install sass-embedded -v 1.63.3 + gem update --system sudo gem install jekyll bundler - name: Set up Node.js ${{ matrix.node-version }} From e43b7c4f91371a5d60f057ad9b67cb56e3278816 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 12 Jun 2023 09:35:09 -0500 Subject: [PATCH 08/50] Update continuous_integration.yml Trying newer version of ubuntu to get around jeckyll install errors --- .github/workflows/continuous_integration.yml | 4 +--- 1 file changed, 1 insertion(+), 3 deletions(-) diff --git a/.github/workflows/continuous_integration.yml b/.github/workflows/continuous_integration.yml index 9e459c42..f7c5f9da 100644 --- a/.github/workflows/continuous_integration.yml +++ b/.github/workflows/continuous_integration.yml @@ -8,7 +8,7 @@ on: jobs: validate: name: Validate Implementation Guide - runs-on: ubuntu-20.04 + runs-on: ubuntu-22.04 strategy: matrix: node-version: [14, 16] @@ -25,8 +25,6 @@ jobs: run: | sudo apt-get update sudo apt-get -y install ruby-full build-essential zlib1g-dev - sudo gem install sass-embedded -v 1.63.3 - gem update --system sudo gem install jekyll bundler - name: Set up Node.js ${{ matrix.node-version }} From 97e937e931f0cab8546141f5941588dc13c3c183 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 12 Jun 2023 09:40:26 -0500 Subject: [PATCH 09/50] Update continuous_integration.yml Continuing to try and find a solution to the jeckyll install error --- .github/workflows/continuous_integration.yml | 2 ++ 1 file changed, 2 insertions(+) diff --git a/.github/workflows/continuous_integration.yml b/.github/workflows/continuous_integration.yml index f7c5f9da..1516258d 100644 --- a/.github/workflows/continuous_integration.yml +++ b/.github/workflows/continuous_integration.yml @@ -25,6 +25,8 @@ jobs: run: | sudo apt-get update sudo apt-get -y install ruby-full build-essential zlib1g-dev + sudo gem update --system + sudo gem install sass-embedded -v 1.63.3 sudo gem install jekyll bundler - name: Set up Node.js ${{ matrix.node-version }} From 883e8431865422782cf2b4904f3e6c2979b59408 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 12 Jun 2023 10:54:19 -0500 Subject: [PATCH 10/50] Added term to support examples --- input/fsh/CodeSystem-HPO.fsh | 1 + 1 file changed, 1 insertion(+) diff --git a/input/fsh/CodeSystem-HPO.fsh b/input/fsh/CodeSystem-HPO.fsh index ce2b3204..0d607f0a 100755 --- a/input/fsh/CodeSystem-HPO.fsh +++ b/input/fsh/CodeSystem-HPO.fsh @@ -1913,3 +1913,4 @@ Description: "The Human Phenotype Ontology (HPO) provides a standardized vocabul * #HP:0006808 "Cerebral hypomyelination" * #HP:0002926 "Abnormality of thyroid physiology" * #HP:0007970 "Congenital ptosis" +* #HP:0030853 "Heterotaxy" From e38c098705b33736e377b935d10c930bb7c6d94b Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 12 Jun 2023 10:54:56 -0500 Subject: [PATCH 11/50] Migrated to Ubuntu 22-04 and Java 11 to overcome jackyll errors --- .github/workflows/continuous_integration.yml | 4 ++-- .github/workflows/deploy_preview.yml | 4 ++-- .github/workflows/publish.yml | 4 ++-- .github/workflows/release.yml | 2 +- 4 files changed, 7 insertions(+), 7 deletions(-) diff --git a/.github/workflows/continuous_integration.yml b/.github/workflows/continuous_integration.yml index 1516258d..be5aebb1 100644 --- a/.github/workflows/continuous_integration.yml +++ b/.github/workflows/continuous_integration.yml @@ -11,7 +11,7 @@ jobs: runs-on: ubuntu-22.04 strategy: matrix: - node-version: [14, 16] + node-version: [10, 12] steps: - name: Check out branch uses: actions/checkout@v2 @@ -19,7 +19,7 @@ jobs: - name: Set up OpenJDK uses: actions/setup-java@v1 with: - java-version: 8 + java-version: 11 - name: Set up Jekyll run: | diff --git a/.github/workflows/deploy_preview.yml b/.github/workflows/deploy_preview.yml index c9229a65..76a81cfd 100644 --- a/.github/workflows/deploy_preview.yml +++ b/.github/workflows/deploy_preview.yml @@ -7,7 +7,7 @@ on: jobs: publish: name: 📝 Preview Implementation Guide - runs-on: ubuntu-20.04 + runs-on: ubuntu-22.04 steps: - name: 👩‍💻 Checkout code uses: actions/checkout@v3 @@ -15,7 +15,7 @@ jobs: - name: 🛠 Set up OpenJDK uses: actions/setup-java@v1 with: - java-version: 8 + java-version: 11 - name: 🛠 Set up Jekyll run: | diff --git a/.github/workflows/publish.yml b/.github/workflows/publish.yml index 2d5df27d..5be15656 100644 --- a/.github/workflows/publish.yml +++ b/.github/workflows/publish.yml @@ -10,7 +10,7 @@ on: jobs: publish: name: Publish Implementation Guide - runs-on: ubuntu-20.04 + runs-on: ubuntu-22.04 strategy: matrix: node-version: [10, 12] @@ -21,7 +21,7 @@ jobs: - name: Set up OpenJDK uses: actions/setup-java@v1 with: - java-version: 8 + java-version: 11 - name: Set up Jekyll run: | diff --git a/.github/workflows/release.yml b/.github/workflows/release.yml index f2d39753..348571ac 100644 --- a/.github/workflows/release.yml +++ b/.github/workflows/release.yml @@ -10,7 +10,7 @@ on: jobs: release: if: github.event.pull_request.merged && contains(github.event.pull_request.labels.*.name, 'release') - runs-on: ubuntu-20.04 + runs-on: ubuntu-22.04 steps: - name: Manual workaround for Github not having a runtime macro to check for the default branch id: gatekeeper From 79abb2ebe78f5ae1b37302f0c39f03903e985d04 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 12 Jun 2023 11:11:15 -0500 Subject: [PATCH 12/50] Remove bad test fix that prevented CI from working --- .github/workflows/continuous_integration.yml | 4 +--- 1 file changed, 1 insertion(+), 3 deletions(-) diff --git a/.github/workflows/continuous_integration.yml b/.github/workflows/continuous_integration.yml index be5aebb1..385c336e 100644 --- a/.github/workflows/continuous_integration.yml +++ b/.github/workflows/continuous_integration.yml @@ -25,9 +25,7 @@ jobs: run: | sudo apt-get update sudo apt-get -y install ruby-full build-essential zlib1g-dev - sudo gem update --system - sudo gem install sass-embedded -v 1.63.3 - sudo gem install jekyll bundler + sudo gem install jekyll --version="~> 4.2.0" bundler - name: Set up Node.js ${{ matrix.node-version }} uses: actions/setup-node@v2 From 7a8ae36706faf1b6d372cf44ea68d8bb2b5502c2 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 12 Jun 2023 11:25:15 -0500 Subject: [PATCH 13/50] Remove bad test fix that prevented CI from working --- .github/workflows/continuous_integration.yml | 2 +- 1 file changed, 1 insertion(+), 1 deletion(-) diff --git a/.github/workflows/continuous_integration.yml b/.github/workflows/continuous_integration.yml index 385c336e..73242d1f 100644 --- a/.github/workflows/continuous_integration.yml +++ b/.github/workflows/continuous_integration.yml @@ -25,7 +25,7 @@ jobs: run: | sudo apt-get update sudo apt-get -y install ruby-full build-essential zlib1g-dev - sudo gem install jekyll --version="~> 4.2.0" bundler + sudo gem install jekyll bundler - name: Set up Node.js ${{ matrix.node-version }} uses: actions/setup-node@v2 From 615724cc0e8881c26399a183cda105274fdb5865 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 12 Jun 2023 16:49:26 -0500 Subject: [PATCH 14/50] moved the consent codes to be separate codings --- input/fsh/Example-CMG-ResearchStudy.fsh | 10 +++++----- 1 file changed, 5 insertions(+), 5 deletions(-) diff --git a/input/fsh/Example-CMG-ResearchStudy.fsh b/input/fsh/Example-CMG-ResearchStudy.fsh index 48c8441a..821f4264 100644 --- a/input/fsh/Example-CMG-ResearchStudy.fsh +++ b/input/fsh/Example-CMG-ResearchStudy.fsh @@ -75,8 +75,8 @@ Usage: #example Description: "Consented with Health/Medical/Biomedical + Not for profit use" * status = #draft * scope = #research -* category.coding[0] = $nihcc#HMB -* category.coding[1] = $nihcc#NPU +* category[+].coding = $nihcc#HMB +* category[+].coding = $nihcc#NPU * category.text = "HMB-NPU" Instance: cmg-research-study-subject-cmg-hmb-npu @@ -110,9 +110,9 @@ Usage: #example Description: "Consented with Health/Medical/Biomedical + IRB Required + Not for profit use" * status = #draft * scope = #research -* category.coding[0] = $nihcc#HMB -* category.coding[1] = $nihcc#IRB -* category.coding[2] = $nihcc#NPU +* category[0].coding = $nihcc#HMB +* category[+].coding = $nihcc#IRB +* category[+].coding = $nihcc#NPU * category.text = "HMB-IRB-NPU" Instance: cmg-research-study-subject-cmg-hmb-irb-npu From 33b46d5f9aea27120a0a8cfe7f224ddeabc42a69 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 12 Jun 2023 16:50:01 -0500 Subject: [PATCH 15/50] Initial content for ResearchStudyConsent pages --- .../StructureDefinition-research-study-consent-intro.md | 3 +++ .../StructureDefinition-research-study-consent-notes.md | 0 2 files changed, 3 insertions(+) create mode 100644 input/pagecontent/StructureDefinition-research-study-consent-intro.md create mode 100644 input/pagecontent/StructureDefinition-research-study-consent-notes.md diff --git a/input/pagecontent/StructureDefinition-research-study-consent-intro.md b/input/pagecontent/StructureDefinition-research-study-consent-intro.md new file mode 100644 index 00000000..e0de3c87 --- /dev/null +++ b/input/pagecontent/StructureDefinition-research-study-consent-intro.md @@ -0,0 +1,3 @@ +The ResearchStudyConsent profile is designed to conform to the same guidelines as found in the DbGaP/NIH Consent model. In this model, the consent's category contains an array of codes for each of the restrictions specified in the given consent. For instance, [HMB-NPU Consent](consent-hmb-npu-consent.html), there would be two codings contained within the category: One for the HBM restriction and one for the NPU. Those restrictions must be selected from the CodeSystem, [NIH Consent](codesystem-nih-consent.html). For more disease specific restrictions, the code _DS_ is to be used along with a corresponding disease code, such as _DS-BAV_ is to be appended via the (Research Consent Disease Abbreviation)[Research Consent Disease Abbreviation](structuredefinition-research-consent-disease-abbreviation.html). Finally, the category's *text* property will contain the combined category code. In the example above, it would simply be *HMB-NPU*. + +Each ResearchStudyConsent resource is intended to be a singular resource that is used by all participants that were enrolled into the study under the particular consent agreement. As such, the model differs somewhat from the R4 Consent model. In this model, for each distinct consent agreement present in the study will be represented by a (ResearchStudySubject)(StructureDefinition-research-study-subject.html) which contains a single [Study Group](StructureDefinition-study-group.html) that may contain references to each participant consented by the relevant agreement. This ResearchStudySubject will contain a reference to the corresponding ResearchStudyConsent resource via the [Research Study Subject Consent](StructureDefinition-research-study-subject-consent.html). diff --git a/input/pagecontent/StructureDefinition-research-study-consent-notes.md b/input/pagecontent/StructureDefinition-research-study-consent-notes.md new file mode 100644 index 00000000..e69de29b From 8ed99f9ca2a77a2df8511b68f0ac874ea1dcd5f2 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 12 Jun 2023 16:50:34 -0500 Subject: [PATCH 16/50] Stubs for page content for ResearchStudySubject --- .../StructureDefinition-research-study-subject-intro.md | 1 + .../StructureDefinition-research-study-subject-notes.md | 0 2 files changed, 1 insertion(+) create mode 100644 input/pagecontent/StructureDefinition-research-study-subject-intro.md create mode 100644 input/pagecontent/StructureDefinition-research-study-subject-notes.md diff --git a/input/pagecontent/StructureDefinition-research-study-subject-intro.md b/input/pagecontent/StructureDefinition-research-study-subject-intro.md new file mode 100644 index 00000000..2f2f302e --- /dev/null +++ b/input/pagecontent/StructureDefinition-research-study-subject-intro.md @@ -0,0 +1 @@ +The ResearchStudySubject profile provides an R4 proxy for the more flexible R5 ResearchSubject. \ No newline at end of file diff --git a/input/pagecontent/StructureDefinition-research-study-subject-notes.md b/input/pagecontent/StructureDefinition-research-study-subject-notes.md new file mode 100644 index 00000000..e69de29b From e7eb5e818d10eeb04b7f0578bc179d521231af64 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 12 Jun 2023 17:11:42 -0500 Subject: [PATCH 17/50] A bit more information about the research study subject resource --- input/fsh/Profile-ResearchStudySubject.fsh | 2 +- .../StructureDefinition-research-study-subject-intro.md | 4 +++- 2 files changed, 4 insertions(+), 2 deletions(-) diff --git a/input/fsh/Profile-ResearchStudySubject.fsh b/input/fsh/Profile-ResearchStudySubject.fsh index 07594d50..7cea514f 100644 --- a/input/fsh/Profile-ResearchStudySubject.fsh +++ b/input/fsh/Profile-ResearchStudySubject.fsh @@ -8,7 +8,7 @@ Profile: ResearchStudySubject Parent: NcpiResearchStudy Id: research-study-subject Title: "Research Study Subject" -Description: "A ResearchStudySubject is representative of a group of participants whose consent and data use is governed by the same restrictions." +Description: "A ResearchStudySubject is representative of a group of participants whose consent and data use is governed by the same restrictions. This profile is an R4 proxy for the more flexible R5 ResearchSubject." * ^version = "0.1.0" * ^status = #draft * partOf 1..1 diff --git a/input/pagecontent/StructureDefinition-research-study-subject-intro.md b/input/pagecontent/StructureDefinition-research-study-subject-intro.md index 2f2f302e..d714e4d6 100644 --- a/input/pagecontent/StructureDefinition-research-study-subject-intro.md +++ b/input/pagecontent/StructureDefinition-research-study-subject-intro.md @@ -1 +1,3 @@ -The ResearchStudySubject profile provides an R4 proxy for the more flexible R5 ResearchSubject. \ No newline at end of file +Based on the [NCPI Research Study](StructureDefinition-ncpi-research-study.html) profile, this resource **must** have a _partOf_ property which points to the main NcpiResearchStudy resource. It **should** also use the [Research Study Subject Consent extension](StructureDefinition-research-study-subject-consent.html) to point to the corresponding consent resource. + +Because it is derived from the NCPI Research Study profile, the resource's enrollment must contain a single [Study Group](StructureDefinition-study-group.html). \ No newline at end of file From f0be3d4fd0da64bd6a9f4b9379547fef188cb489 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Tue, 13 Jun 2023 17:44:33 -0500 Subject: [PATCH 18/50] Refactor CMG Consent examples to use provision instead of category --- input/fsh/Example-CMG-ResearchStudy.fsh | 18 +++++++++++------- ...eDefinition-research-study-consent-intro.md | 2 +- 2 files changed, 12 insertions(+), 8 deletions(-) diff --git a/input/fsh/Example-CMG-ResearchStudy.fsh b/input/fsh/Example-CMG-ResearchStudy.fsh index 821f4264..4c65b312 100644 --- a/input/fsh/Example-CMG-ResearchStudy.fsh +++ b/input/fsh/Example-CMG-ResearchStudy.fsh @@ -75,9 +75,11 @@ Usage: #example Description: "Consented with Health/Medical/Biomedical + Not for profit use" * status = #draft * scope = #research -* category[+].coding = $nihcc#HMB -* category[+].coding = $nihcc#NPU -* category.text = "HMB-NPU" +* category.coding = http://terminology.hl7.org/CodeSystem/consentcategorycodes#research +* provision.type = http://hl7.org/fhir/consent-provision-type#permit +* provision.purpose[+] = $nihcc#HMB +* provision.purpose[+] = $nihcc#NPU +//* category.text = "HMB-NPU" Instance: cmg-research-study-subject-cmg-hmb-npu InstanceOf: ResearchStudySubject @@ -110,10 +112,12 @@ Usage: #example Description: "Consented with Health/Medical/Biomedical + IRB Required + Not for profit use" * status = #draft * scope = #research -* category[0].coding = $nihcc#HMB -* category[+].coding = $nihcc#IRB -* category[+].coding = $nihcc#NPU -* category.text = "HMB-IRB-NPU" +* category.coding = http://terminology.hl7.org/CodeSystem/consentcategorycodes#research +* provision.type = http://hl7.org/fhir/consent-provision-type#permit +* provision.purpose[+] = $nihcc#HMB +* provision.purpose[+] = $nihcc#IRB +* provision.purpose[+] = $nihcc#NPU +//* category.text = "HMB-IRB-NPU" Instance: cmg-research-study-subject-cmg-hmb-irb-npu InstanceOf: ResearchStudySubject diff --git a/input/pagecontent/StructureDefinition-research-study-consent-intro.md b/input/pagecontent/StructureDefinition-research-study-consent-intro.md index e0de3c87..fccf12f0 100644 --- a/input/pagecontent/StructureDefinition-research-study-consent-intro.md +++ b/input/pagecontent/StructureDefinition-research-study-consent-intro.md @@ -1,3 +1,3 @@ -The ResearchStudyConsent profile is designed to conform to the same guidelines as found in the DbGaP/NIH Consent model. In this model, the consent's category contains an array of codes for each of the restrictions specified in the given consent. For instance, [HMB-NPU Consent](consent-hmb-npu-consent.html), there would be two codings contained within the category: One for the HBM restriction and one for the NPU. Those restrictions must be selected from the CodeSystem, [NIH Consent](codesystem-nih-consent.html). For more disease specific restrictions, the code _DS_ is to be used along with a corresponding disease code, such as _DS-BAV_ is to be appended via the (Research Consent Disease Abbreviation)[Research Consent Disease Abbreviation](structuredefinition-research-consent-disease-abbreviation.html). Finally, the category's *text* property will contain the combined category code. In the example above, it would simply be *HMB-NPU*. +The ResearchStudyConsent profile is designed to conform to the same guidelines as found in the DbGaP/NIH Consent model. In this model, the consent's category contains an array of codes for each of the restrictions specified in the given consent. For instance, [HMB-NPU Consent](consent-hmb-npu-consent.html), there would be two codes added to the provision's purpose property: One for the HBM restriction and one for the NPU. Those restrictions must be selected from the CodeSystem, [NIH Consent](codesystem-nih-consent.html). For more disease specific restrictions, the code _DS_ is to be used along with a corresponding disease code(s) added via the[Research Consent Disease Restrictions](structuredefinition-research-consent-disease-restrictions.html). Each ResearchStudyConsent resource is intended to be a singular resource that is used by all participants that were enrolled into the study under the particular consent agreement. As such, the model differs somewhat from the R4 Consent model. In this model, for each distinct consent agreement present in the study will be represented by a (ResearchStudySubject)(StructureDefinition-research-study-subject.html) which contains a single [Study Group](StructureDefinition-study-group.html) that may contain references to each participant consented by the relevant agreement. This ResearchStudySubject will contain a reference to the corresponding ResearchStudyConsent resource via the [Research Study Subject Consent](StructureDefinition-research-study-subject-consent.html). From ba9298406f780ca10d79f6ebb3d09d6a82f8fd61 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 19 Jun 2023 13:05:39 -0500 Subject: [PATCH 19/50] Add the URN for Mesh as DbGAP has it --- input/fsh/Alias.fsh | 2 ++ 1 file changed, 2 insertions(+) diff --git a/input/fsh/Alias.fsh b/input/fsh/Alias.fsh index 3649652a..35c1e1f7 100755 --- a/input/fsh/Alias.fsh +++ b/input/fsh/Alias.fsh @@ -59,6 +59,8 @@ Alias: $hpo = http://purl.obolibrary.org/obo/hp.owl Alias: $omim = https://omim.org/ Alias: $mondo = http://purl.obolibrary.org/obo/mondo.owl +Alias: $mesh = urn:oid:2.16.840.1.113883.6.177 + // ValueSet Alias: $disease-codes = http://fhir.ncpi-project-forge.io/ValueSet/disease-codes Alias: $phenotype-codes = http://fhir.ncpi-project-forge.io/ValueSet/phenotype-codes From 7784b82553fd25947fa5c1f67154ab9f120ed6ea Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 19 Jun 2023 13:06:34 -0500 Subject: [PATCH 20/50] Add term used by one of the CMG disease restrictions --- input/fsh/CodeSystem-HPO.fsh | 1 + 1 file changed, 1 insertion(+) diff --git a/input/fsh/CodeSystem-HPO.fsh b/input/fsh/CodeSystem-HPO.fsh index 0d607f0a..405e41ad 100755 --- a/input/fsh/CodeSystem-HPO.fsh +++ b/input/fsh/CodeSystem-HPO.fsh @@ -1914,3 +1914,4 @@ Description: "The Human Phenotype Ontology (HPO) provides a standardized vocabul * #HP:0002926 "Abnormality of thyroid physiology" * #HP:0007970 "Congenital ptosis" * #HP:0030853 "Heterotaxy" +* #HP:0010772 "Anomalous pulmonary venous return" \ No newline at end of file From 3b8994c68cee440ce150fe77a3dc422de45637f7 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 19 Jun 2023 13:08:39 -0500 Subject: [PATCH 21/50] Fixed code systems to eliminate some errors in publisher's qa report --- input/fsh/CodeSystem-LoincAnswers.fsh | 2 +- input/fsh/Example-ConceptMap-DataDictionary.fsh | 4 ++-- input/fsh/Example-Dataset-DataDictionary.fsh | 4 ++-- input/fsh/ValueSet-LoincAnswers.fsh | 2 +- .../Observation-example-observation-data-row-1-intro.md | 2 +- .../Observation-example-study-summary-gender-intro.md | 2 +- ...stionnaire-example-questionnaire-demographics-1-intro.md | 2 +- input/pagecontent/example_raw_data.md | 6 +++--- 8 files changed, 12 insertions(+), 12 deletions(-) diff --git a/input/fsh/CodeSystem-LoincAnswers.fsh b/input/fsh/CodeSystem-LoincAnswers.fsh index 63053f0a..25c26651 100755 --- a/input/fsh/CodeSystem-LoincAnswers.fsh +++ b/input/fsh/CodeSystem-LoincAnswers.fsh @@ -2,7 +2,7 @@ CodeSystem: LoincAnswers Id: loinc-answers Title: "LOINC Answers" Description: "LOINC ANSWERS used by NCPI resources" -* ^url = "ncpi:loinc-answers" +* ^url = "https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/loinc-answers" * ^status = #draft * ^experimental = false * ^caseSensitive = true diff --git a/input/fsh/Example-ConceptMap-DataDictionary.fsh b/input/fsh/Example-ConceptMap-DataDictionary.fsh index f6c90f16..7d4d6de8 100644 --- a/input/fsh/Example-ConceptMap-DataDictionary.fsh +++ b/input/fsh/Example-ConceptMap-DataDictionary.fsh @@ -24,8 +24,8 @@ The codes used below were chosen purely for example's sake and are in no way an * $loinc#LP35925-4 "Body mass index (BMI)" * $umls#C0872128 "case control" * $hpo#HP:0010772 "Anomalous pulmonary venous return" -* $mondo#0017705 "congenital pulmonary venous return anomaly" -* $mondo#0007130 "congenital total pulmonary venous return anomaly" +* $mondo#MONDO:0017705 "congenital pulmonary venous return anomaly" +* $mondo#MONDO:0007130 "congenital total pulmonary venous return anomaly" Instance: example-study-data-dictionary-conceptmap-1 InstanceOf: StudyDataDictionaryHarmony diff --git a/input/fsh/Example-Dataset-DataDictionary.fsh b/input/fsh/Example-Dataset-DataDictionary.fsh index c0e07d2e..126c1608 100644 --- a/input/fsh/Example-Dataset-DataDictionary.fsh +++ b/input/fsh/Example-Dataset-DataDictionary.fsh @@ -23,7 +23,7 @@ Description: "Example CodeSystem for a data-dictionary dataset with only 1 table * ^url = $ExampleStudyDatasetCS * ^content = #complete * ^count = 1 -* #demographics +* #demographics "Demographics" CodeSystem: ExampleStudyDataDictionaryStudyTableCS1 Id: example-study-data-dictionary-datatable-codesystem-1 @@ -57,7 +57,7 @@ InstanceOf: StudyDataDictionaryTable Title: "Data-Dictionary Table" Description: "Example Study Data Dictionary Data Table definition" * status = #active -* code.coding = $ExampleStudyDatasetCS#demographics "Demographic data" +* code.coding = $ExampleStudyDatasetCS#demographics "Demographics" * topic.coding = $umls#C0035168 "Research" * observationResultRequirement[0] = Reference(example-study-data-dictionary-variable-1-1) * observationResultRequirement[1] = Reference(example-study-data-dictionary-variable-1-2) diff --git a/input/fsh/ValueSet-LoincAnswers.fsh b/input/fsh/ValueSet-LoincAnswers.fsh index a7ef7c20..ba1130e8 100755 --- a/input/fsh/ValueSet-LoincAnswers.fsh +++ b/input/fsh/ValueSet-LoincAnswers.fsh @@ -8,4 +8,4 @@ Description: "LOINC ANSWERS used by NCPI resources" * ^status = #draft * ^experimental = false * ^publisher = "NCPI Project Forge" -* include codes from system ncpi:loinc-answers +* include codes from system https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/loinc-answers diff --git a/input/pagecontent/Observation-example-observation-data-row-1-intro.md b/input/pagecontent/Observation-example-observation-data-row-1-intro.md index 217c5d2d..441ffc1f 100644 --- a/input/pagecontent/Observation-example-observation-data-row-1-intro.md +++ b/input/pagecontent/Observation-example-observation-data-row-1-intro.md @@ -1,3 +1,3 @@ In this example, we provide a single "row" of data as an Observation. The row's subject references the relevant Patient resource while the specimen resource references the the relevant Specimen resource (most, if not all rows, should provide a reference to the subject, but the specimen may only apply to rows from specific tables.) -Notice the use of codes from the study's data-dictionary code systems. For the Observation's code, we use the study's entry, [demographics](CodeSystem-example-study-dd-dataset-codesystem-1.html) from the dataset code system. For each of the variables, represented here as elements in the component array, the codes used are from the related variable's entry in the table's [CodeSystem](CodeSystem-example-study-dd-datatable-codesystem-1.html). +Notice the use of codes from the study's data-dictionary code systems. For the Observation's code, we use the study's entry, [demographics](CodeSystem-example-study-data-dictionary-dataset-codesystem-1.html) from the dataset code system. For each of the variables, represented here as elements in the component array, the codes used are from the related variable's entry in the table's [CodeSystem](CodeSystem-example-study-data-dictionary-datatable-codesystem-1.html). diff --git a/input/pagecontent/Observation-example-study-summary-gender-intro.md b/input/pagecontent/Observation-example-study-summary-gender-intro.md index b213b831..321ac966 100644 --- a/input/pagecontent/Observation-example-study-summary-gender-intro.md +++ b/input/pagecontent/Observation-example-study-summary-gender-intro.md @@ -1,4 +1,4 @@ -The following study variable summary highlights the basic format one can expect when producing as well as consuming these summaries. The code is set to a common code, C0242482 which indicates that the Observation is a Summary Report. The subject property is set the the population from which the summary data was collected, in this case the [Entire Study Population](Group-example-summary-group-1.html). The Focus references the [study itself](ResearchStudy-ncpi-research-study-01.html). For the value[X] portion of the resource, we have described the source of the summary data which happens to be the "gender" code from the [demographics-table](CodeSystem-example-study-dd-datatable-codesystem-1.html) along with a harmonized coding mapping that variable to the UMLS code for "Gender", C0079399. +The following study variable summary highlights the basic format one can expect when producing as well as consuming these summaries. The code is set to a common code, C0242482 which indicates that the Observation is a Summary Report. The subject property is set the the population from which the summary data was collected, in this case the [Entire Study Population](Group-example-summary-group-1.html). The Focus references the [study itself](ResearchStudy-ncpi-research-study-01.html). For the value[X] portion of the resource, we have described the source of the summary data which happens to be the "gender" code from the [demographics-table](CodeSystem-example-study-data-dictionary-dataset-codesystem-1.html) along with a harmonized coding mapping that variable to the UMLS code for "Gender", C0079399. Finally, we have the summary data listed as components. diff --git a/input/pagecontent/Questionnaire-example-questionnaire-demographics-1-intro.md b/input/pagecontent/Questionnaire-example-questionnaire-demographics-1-intro.md index 3eefd9d7..2b13b8e5 100644 --- a/input/pagecontent/Questionnaire-example-questionnaire-demographics-1-intro.md +++ b/input/pagecontent/Questionnaire-example-questionnaire-demographics-1-intro.md @@ -1,3 +1,3 @@ In order to represent data with QuestionnaireResponses, one must provide a Questionnaire to describe the data format. In this example we have a single table, Demographics, which has 5 fields, each of which are described as separate *items*. Each of the items has a type, and for "multiple choice" type values, a ValueSet URL is also provided. -Note that each of the items links back to the data-dictionary by way of their codes from the [Demographics CodeSystem](CodeSystem-example-study-dd-dataset-codesystem-1.html). \ No newline at end of file +Note that each of the items links back to the data-dictionary by way of their codes from the [Demographics CodeSystem](CodeSystem-example-study-data-dictionary-dataset-codesystem-1.html). \ No newline at end of file diff --git a/input/pagecontent/example_raw_data.md b/input/pagecontent/example_raw_data.md index 0cb3b2fb..21aea40b 100644 --- a/input/pagecontent/example_raw_data.md +++ b/input/pagecontent/example_raw_data.md @@ -7,20 +7,20 @@ An example of using an Observation to represent tabular data can be found [here. In order to use Observations to represent tabular data, we'll need to have previously defined our data dictionary, since those resources will be vital for clients to properly interpret the resource's contents. Each Observation resource represents a single row from one table. -The first thing to note is that we've set the Observation's code to the table's code from the study's [dataset CodeSystem](CodeSystem-example-study-dd-dataset-codesystem-1.html). In this case, it's the code, *demographics*. While not absolutely required, it is highly recommended that the subject be set to the corresponding Patient resource so that these observations can be easily found using basic FHIR queries. In this case, such a query might look like: *Observation?code=http://example.org/my-dataset/fhir/codesystem/dataset|demographics&subject=Patient/ncpi-research-study-01-patient-01*. +The first thing to note is that we've set the Observation's code to the table's code from the study's [dataset CodeSystem](CodeSystem-example-study-data-dictionary-dataset-codesystem-1.html). In this case, it's the code, *demographics*. While not absolutely required, it is highly recommended that the subject be set to the corresponding Patient resource so that these observations can be easily found using basic FHIR queries. In this case, such a query might look like: *Observation?code=http://example.org/my-dataset/fhir/codesystem/dataset|demographics&subject=Patient/ncpi-research-study-01-patient-01*. Observations do permit association to a specimen as well, which may make good since if the row is from a table that provides specimen details. Finally, each of the variables is captured as a component within the Observation's component array. Here, you will see that each of the components has a code that originates from the study's demographics table indicating which variable is being represented. Then, for each of those components, the appropriate value[X] provides the variable's value for that row. So, for the first component, the code indicates that is is the "subjectid" variable with a value of "SUB0001". -To provide context about a given variable's content, the data-dictionary resources should also be present in order to provide type information via the permittedDataType property as well as potential details about min/max, units and others that may have been provided in the Data Dictionary variable resources. For instance, [subjectid](ObservationDefinition-example-study-dd-variable-1-1.json.html) is formally defined to be of type, *string*. Whereas [gender](ObservationDefinition-example-study-dd-variable-1-2.json.html) is defined to be of type *CodeableConcept* with the possible values specified by this [ValueSet](http://hl7.org/fhir/ValueSet/administrative-gender). That information agrees with the contents of this example's resource's components. +To provide context about a given variable's content, the data-dictionary resources should also be present in order to provide type information via the permittedDataType property as well as potential details about min/max, units and others that may have been provided in the Data Dictionary variable resources. For instance, [subjectid](ObservationDefinition-example-study-data-dictionary-variable-1-1.json.html) is formally defined to be of type, *string*. Whereas [gender](ObservationDefinition-example-study-data-dictionary-variable-1-2.json.html) is defined to be of type *CodeableConcept* with the possible values specified by this [ValueSet](http://hl7.org/fhir/ValueSet/administrative-gender). That information agrees with the contents of this example's resource's components. One advantage of using Observations with components for tabular data is the fact that they should be searchable from any truly compliant FHIR server. So, if one were interested in all rows associated with *cases*, the following query should work: *Observation?code=http://example.org/my-dataset/fhir/codesystem/dataset|demographics&component-value-concept=https://uts.nlm.nih.gov/uts/umls|C99269* ### Tabular Data as Questionnaires and QuestionnaireResponses We provide the same example representing data using Questionnaires and QuestionnaireResponses. -The [Questionnaire](Questionnaire-example-questionnaire-demographics-1.html) defines the structure of how the responses are to be formatted, basically providing details about each of the variables that may be found within a response. The [QuestionnaireResponse](QuestionnaireResponse-example-questionnaire-demographics-response-1.html) simply provides the values for those variables. Similarly to the Observation approach, the code for the Questionnaire links back to the study's data dictionary code for the relevant table, in the case it's [demographics](CodeSystem-example-study-dd-dataset-codesystem-1.html). To tie each of the variables back to the appropriate table, their code entry is used for each of the Questionnaire's item's code. Thus, the code for bmi links back to the bmi entry in the study's demographics table's [CodeSystem](CodeSystem-example-study-dd-datatable-codesystem-1.html). +The [Questionnaire](Questionnaire-example-questionnaire-demographics-1.html) defines the structure of how the responses are to be formatted, basically providing details about each of the variables that may be found within a response. The [QuestionnaireResponse](QuestionnaireResponse-example-questionnaire-demographics-response-1.html) simply provides the values for those variables. Similarly to the Observation approach, the code for the Questionnaire links back to the study's data dictionary code for the relevant table, in the case it's [demographics](CodeSystem-example-study-data-dictionary-dataset-codesystem-1.html). To tie each of the variables back to the appropriate table, their code entry is used for each of the Questionnaire's item's code. Thus, the code for bmi links back to the bmi entry in the study's demographics table's [CodeSystem](CodeSystem-example-study-data-dictionary-dataset-codesystem-1.html). The QuestionnaireResponse's data links back to the relevant variable by way of a common linkId. So, the item associated with the linkId of "gender" is described by the Questionnaire's item with the same linkId. From 5fac62f77d20d183755ea0638f25c94388af0d42 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 19 Jun 2023 13:09:11 -0500 Subject: [PATCH 22/50] Add term used by one of the CMG disease restrictions --- input/fsh/CodeSystem-Mondo.fsh | 2 ++ 1 file changed, 2 insertions(+) diff --git a/input/fsh/CodeSystem-Mondo.fsh b/input/fsh/CodeSystem-Mondo.fsh index c3a298a1..6f966c23 100644 --- a/input/fsh/CodeSystem-Mondo.fsh +++ b/input/fsh/CodeSystem-Mondo.fsh @@ -13,3 +13,5 @@ Description: "The Mondo Disease Ontology (Mondo) aims to harmonize disease defin * #MONDO:0008542 "tetralogy of fallot" * #MONDO:0016054 "cerebral malformation" * #MONDO:0016033 "Cornelia de Lange syndrome" +* #MONDO:0007130 "congenital total pulmonary venous return anomaly" +* #MONDO:0017705 "congenital pulmonary venous return anomaly" From 407d71f29ef94107e6ef003b9f84fea1218b229c Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 19 Jun 2023 13:26:05 -0500 Subject: [PATCH 23/50] Refinements to include changing disease restrictions to codes --- input/fsh/Example-ResearchStudy.fsh | 7 +- input/fsh/Profile-ResearchConsent.fsh | 32 ++-- ...Definition-research-study-consent-intro.md | 4 +- input/pagecontent/research_study.md | 4 +- ...tureDefinition-research-study-consent.json | 173 ++++++++++-------- 5 files changed, 121 insertions(+), 99 deletions(-) diff --git a/input/fsh/Example-ResearchStudy.fsh b/input/fsh/Example-ResearchStudy.fsh index 993d7648..56030427 100644 --- a/input/fsh/Example-ResearchStudy.fsh +++ b/input/fsh/Example-ResearchStudy.fsh @@ -41,7 +41,7 @@ Usage: #example Description: "Example Consent resource" * status = #draft * scope = #research -* category = $nihcc#GRU +* provision.purpose[+] = $nihcc#GRU Instance: ds-bav-consent InstanceOf: ResearchStudyConsent @@ -49,8 +49,9 @@ Usage: #example Description: "Example of Disease Specific Consent resource" * status = #draft * scope = #research -* category = $nihcc#DS -* extension[diseaseAbbreviation].valueString = "DS-BAV" +* provision.purpose[+] = $nihcc#DS +* provision.extension[diseaseUseLimitation].valueCodeableConcept.coding = $mesh#D000082882 "Bicuspid Aortic Valve Disease" +//* extension[diseaseAbbreviation].valueString = "DS-BAV" Instance: ncpi-research-study-subject-01 diff --git a/input/fsh/Profile-ResearchConsent.fsh b/input/fsh/Profile-ResearchConsent.fsh index 45ed9fbf..951d8ace 100644 --- a/input/fsh/Profile-ResearchConsent.fsh +++ b/input/fsh/Profile-ResearchConsent.fsh @@ -16,6 +16,14 @@ Description: "Full code string for disease specific consent abbreviations" * value[x] only string * obeys disease-specific-consent-code +Extension: ResearchDiseaseUseLimitation +Id: research-disease-use-limitation +Title: "Research Usage Limitation Disease Code" +Description: "Coding associated with limitation on what research can be performed this data." +* value[x] only CodeableConcept +* valueCodeableConcept from mesh-terms (example) + + // The current version of SMILES CDR that we are using doesn't support // version 4.3.0 resources, and when generating Consent based profiles with // version 4.0.1 resource, sushi generates invalid profiles. @@ -23,14 +31,16 @@ Description: "Full code string for disease specific consent abbreviations" // This profile exists in the resources directory until we have migrated all // R4 servers to a more recent version of HAPI. // -// Profile: ResearchStudyConsent -// Parent: Consent -// Id: research-study-consent -// Title: "Research Study Consent" -// Description: "A ResearchStudyConsent represents the core NIH Consent properties as they apply when consenting subjects to a research study" -// * ^version = "0.1.0" -// * ^status = #draft -// * category from nih-consent-codes (extensible) -// * extension contains ResearchConsentDiseaseAbbreviation named diseaseAbbreviation 0..1 -// * extension[diseaseAbbreviation] ^short = "Consent Code Disease Abbreviation" -// * extension[diseaseAbbreviation].value[x] only string +//Profile: ResearchStudyConsent +//Parent: Consent +//Id: research-study-consent +//Title: "Research Study Consent" +//Description: "A ResearchStudyConsent represents the core NIH Consent properties as they apply when consenting subjects to a research study" +//* ^version = "0.1.0" +//* ^status = #draft +//* category = http://terminology.hl7.org/CodeSystem/consentcategorycodes#research "Research Information Access" +//* provision.purpose from nih-consent-codes (extensible) +//* provision.extension contains ResearchDiseaseUseLimitation named diseaseUseLimitation 0..1 +//* provision.extension[diseaseUseLimitation] ^short = "Consent Code Disease Abbreviation" + +//* extension[diseaseUseLimitation].value[x] only string diff --git a/input/pagecontent/StructureDefinition-research-study-consent-intro.md b/input/pagecontent/StructureDefinition-research-study-consent-intro.md index fccf12f0..06a48090 100644 --- a/input/pagecontent/StructureDefinition-research-study-consent-intro.md +++ b/input/pagecontent/StructureDefinition-research-study-consent-intro.md @@ -1,3 +1,3 @@ -The ResearchStudyConsent profile is designed to conform to the same guidelines as found in the DbGaP/NIH Consent model. In this model, the consent's category contains an array of codes for each of the restrictions specified in the given consent. For instance, [HMB-NPU Consent](consent-hmb-npu-consent.html), there would be two codes added to the provision's purpose property: One for the HBM restriction and one for the NPU. Those restrictions must be selected from the CodeSystem, [NIH Consent](codesystem-nih-consent.html). For more disease specific restrictions, the code _DS_ is to be used along with a corresponding disease code(s) added via the[Research Consent Disease Restrictions](structuredefinition-research-consent-disease-restrictions.html). +The ResearchStudyConsent profile is designed to conform to the same guidelines as found in the DbGaP/NIH Consent model. In this model, the consent's category contains an array of codes for each of the restrictions specified in the given consent. For instance, [HMB-NPU Consent](consent-hmb-npu-consent.html), there would be two codes added to the provision's purpose property: One for the HBM restriction and one for the NPU. Those restrictions must be selected from the CodeSystem, [NIH Consent](codesystem-nih-consent.html). For more disease specific restrictions, the code _DS_ is to be used along with a corresponding disease code(s) added via the [Research Disease Use Limitation](StructureDefinition-research-disease-use-limitation.html). -Each ResearchStudyConsent resource is intended to be a singular resource that is used by all participants that were enrolled into the study under the particular consent agreement. As such, the model differs somewhat from the R4 Consent model. In this model, for each distinct consent agreement present in the study will be represented by a (ResearchStudySubject)(StructureDefinition-research-study-subject.html) which contains a single [Study Group](StructureDefinition-study-group.html) that may contain references to each participant consented by the relevant agreement. This ResearchStudySubject will contain a reference to the corresponding ResearchStudyConsent resource via the [Research Study Subject Consent](StructureDefinition-research-study-subject-consent.html). +Each ResearchStudyConsent resource is intended to be a singular resource that is used by all participants that were enrolled into the study under the particular consent agreement. As such, the model differs somewhat from the R4 Consent model. In this model, for each distinct consent agreement present in the study will be represented by a (ResearchStudySubject)(StructureDefinition-research-study-subject.html) which contains a single [Study Group](StructureDefinition-study-group.html) that may contain references to each participant consented by the relevant agreement. This ResearchStudySubject will contain a reference to the corresponding ResearchStudyConsent resource via the [Research Disease Use Limitation](StructureDefinition-research-disease-use-limitation.html). diff --git a/input/pagecontent/research_study.md b/input/pagecontent/research_study.md index b5d9afee..00676b65 100644 --- a/input/pagecontent/research_study.md +++ b/input/pagecontent/research_study.md @@ -7,7 +7,7 @@ The [NCPI ResearchStudy](StructureDefinition-ncpi-research-study.html) profile i Patient resources are associated with the study by way of the ResearchSubject resource as well as membership in one or more of the StudyGroup resources. #### ResearchConsortium -When capturing studies that are a part of a consortium, the [NCPI ResearchConsortium](StructureDefinition-research-consortium.html) profile should be defined and referenced from the participating studies via the studies' __sponsor__ property. +When capturing studies that are a part of a consortium, the [NCPI ResearchConsortium](StructureDefinition-ncpi-research-consortium.html) profile should be defined and referenced from the participating studies via the studies' __sponsor__ property. ### Conventions For each NCPI Research Study resource, there **must** be at least one [StudyGroup](StructureDefinition-study-group.html). @@ -26,7 +26,7 @@ In addition to a more comprehensive Study Group, Research Studies that exist alo * One or more StudyGroup resources as references in the enrollment property. * Study URLs can be attached via the relatedArtifact property. -* [ResearchConsortium](StructureDefinition-research-consortium.html) can be used to represent studies' participation within a consortium. Using ResearchConsortium provides the ability to search for participating studies using the ResearchStudy's sponsor search parameter. +* [ResearchConsortium](StructureDefinition-ncpi-research-consortium.html) can be used to represent studies' participation within a consortium. Using ResearchConsortium provides the ability to search for participating studies using the ResearchStudy's sponsor search parameter. * [StudyGroup](StructureDefinition-study-group.html) provides information about the study as the number of subjects (quantity) as well as an explicit listing of the Patients as references in the group's member property when the Study resource is present in a server with row-level data. The can be more than one StudyGroup associated with a given Study. diff --git a/input/resources/StructureDefinition-research-study-consent.json b/input/resources/StructureDefinition-research-study-consent.json index 68bb4c26..ac7ceb75 100644 --- a/input/resources/StructureDefinition-research-study-consent.json +++ b/input/resources/StructureDefinition-research-study-consent.json @@ -3,14 +3,14 @@ "id" : "research-study-consent", "text" : { "status" : "extensions", - "div" : "
\r\n\r\n\r\n\r\n
NameFlagsCard.TypeDescription & Constraints\"doco\"
\".\"\".\" Consent 0..*ConsentA healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time
\".\"\".\"\".\" Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
\".\"\".\"\".\" diseaseAbbreviation 0..1stringConsent Code Disease Abbreviation
URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-consent-disease-abbreviation
\".\"\".\"\".\" category 1..*CodeableConceptClassification of the consent statement - for indexing/retrieval
Binding: NIH Consent Code ValueSet (extensible)

\"doco\" Documentation for this format
" + "div" : "
\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n
NameFlagsCard.TypeDescription & Constraints\"doco\"
\".\"\".\" Consent 0..*ConsentA healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time
\".\"\".\"\".\" category 1..*CodeableConceptClassification of the consent statement - for indexing/retrieval
Required Pattern: At least the following
\".\"\".\"\".\"\".\" coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
\".\"\".\"\".\"\".\"\".\" system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/consentcategorycodes
\".\"\".\"\".\"\".\"\".\" code1..1codeSymbol in syntax defined by the system
Fixed Value: research
\".\"\".\"\".\"\".\"\".\" display1..1stringRepresentation defined by the system
Fixed Value: Research Information Access
\".\"\".\"\".\" provision
\".\"\".\"\".\"\".\" Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
\".\"\".\"\".\"\".\" diseaseUseLimitation 0..1CodeableConceptConsent Code Disease Abbreviation
URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation
Binding: MeSH Terms (example)
\".\"\".\"\".\"\".\" purpose 0..*CodingContext of activities covered by this rule
Binding: NIH Consent Code ValueSet (extensible)

\"doco\" Documentation for this format
" }, "url" : "https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-consent", "version" : "0.2.0", "name" : "ResearchStudyConsent", "title" : "Research Study Consent", "status" : "draft", - "date" : "2023-06-09T12:35:36-05:00", + "date" : "2023-06-19T10:28:49-05:00", "publisher" : "NCPI FHIR Working Group", "contact" : [{ "name" : "NCPI FHIR Working Group", @@ -360,16 +360,11 @@ { "id" : "Consent.extension", "path" : "Consent.extension", - "slicing" : { - "discriminator" : [{ - "type" : "value", - "path" : "url" - }], - "ordered" : false, - "rules" : "open" - }, - "short" : "Extension", - "definition" : "An Extension", + "short" : "Additional content defined by implementations", + "definition" : "May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", + "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", + "alias" : ["extensions", + "user content"], "min" : 0, "max" : "*", "base" : { @@ -397,50 +392,11 @@ "source" : "http://hl7.org/fhir/StructureDefinition/Extension" }], "isModifier" : false, - "isSummary" : false - }, - { - "id" : "Consent.extension:diseaseAbbreviation", - "path" : "Consent.extension", - "sliceName" : "diseaseAbbreviation", - "short" : "Consent Code Disease Abbreviation", - "definition" : "Full code string for disease specific consent abbreviations", - "min" : 0, - "max" : "1", - "base" : { - "path" : "DomainResource.extension", - "min" : 0, - "max" : "*" - }, - "type" : [{ - "code" : "Extension", - "profile" : ["https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-consent-disease-abbreviation"] - }], - "condition" : ["ele-1"], - "constraint" : [{ - "key" : "ele-1", - "severity" : "error", - "human" : "All FHIR elements must have a @value or children", - "expression" : "hasValue() or (children().count() > id.count())", - "xpath" : "@value|f:*|h:div", - "source" : "http://hl7.org/fhir/StructureDefinition/Element" - }, - { - "key" : "ext-1", - "severity" : "error", - "human" : "Must have either extensions or value[x], not both", - "expression" : "extension.exists() != value.exists()", - "xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])", - "source" : "http://hl7.org/fhir/StructureDefinition/Extension" - }, - { - "key" : "disease-specific-consent-code", - "severity" : "error", - "human" : "Disease Specific components reflect the content that appears after the DS- portion of the NIH style consent code.", - "expression" : "valueString.matches('DS-[A-Z]+')", - "source" : "https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-consent-disease-abbreviation" - }], - "isModifier" : false + "isSummary" : false, + "mapping" : [{ + "identity" : "rim", + "map" : "N/A" + }] }, { "id" : "Consent.modifierExtension", @@ -629,6 +585,13 @@ "type" : [{ "code" : "CodeableConcept" }], + "patternCodeableConcept" : { + "coding" : [{ + "system" : "http://terminology.hl7.org/CodeSystem/consentcategorycodes", + "code" : "research", + "display" : "Research Information Access" + }] + }, "constraint" : [{ "key" : "ele-1", "severity" : "error", @@ -640,8 +603,13 @@ "isModifier" : false, "isSummary" : true, "binding" : { + "extension" : [{ + "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", + "valueString" : "ConsentCategory" + }], "strength" : "extensible", - "valueSet" : "https://nih-ncpi.github.io/ncpi-fhir-ig/ValueSet/nih-consent-codes" + "description" : "A classification of the type of consents found in a consent statement.", + "valueSet" : "http://hl7.org/fhir/ValueSet/consent-category" }, "mapping" : [{ "identity" : "workflow", @@ -1375,11 +1343,16 @@ { "id" : "Consent.provision.extension", "path" : "Consent.provision.extension", - "short" : "Additional content defined by implementations", - "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", - "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", - "alias" : ["extensions", - "user content"], + "slicing" : { + "discriminator" : [{ + "type" : "value", + "path" : "url" + }], + "ordered" : false, + "rules" : "open" + }, + "short" : "Extension", + "definition" : "An Extension", "min" : 0, "max" : "*", "base" : { @@ -1407,11 +1380,43 @@ "source" : "http://hl7.org/fhir/StructureDefinition/Extension" }], "isModifier" : false, - "isSummary" : false, - "mapping" : [{ - "identity" : "rim", - "map" : "n/a" - }] + "isSummary" : false + }, + { + "id" : "Consent.provision.extension:diseaseUseLimitation", + "path" : "Consent.provision.extension", + "sliceName" : "diseaseUseLimitation", + "short" : "Consent Code Disease Abbreviation", + "definition" : "Coding associated with limitation on what research can be performed this data.", + "min" : 0, + "max" : "1", + "base" : { + "path" : "Element.extension", + "min" : 0, + "max" : "*" + }, + "type" : [{ + "code" : "Extension", + "profile" : ["https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation"] + }], + "condition" : ["ele-1"], + "constraint" : [{ + "key" : "ele-1", + "severity" : "error", + "human" : "All FHIR elements must have a @value or children", + "expression" : "hasValue() or (children().count() > id.count())", + "xpath" : "@value|f:*|h:div", + "source" : "http://hl7.org/fhir/StructureDefinition/Element" + }, + { + "key" : "ext-1", + "severity" : "error", + "human" : "Must have either extensions or value[x], not both", + "expression" : "extension.exists() != value.exists()", + "xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])", + "source" : "http://hl7.org/fhir/StructureDefinition/Extension" + }], + "isModifier" : false }, { "id" : "Consent.provision.modifierExtension", @@ -1834,13 +1839,8 @@ "isModifier" : false, "isSummary" : true, "binding" : { - "extension" : [{ - "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", - "valueString" : "PurposeOfUse" - }], "strength" : "extensible", - "description" : "What purposes of use are controlled by this exception. If more than one label is specified, operations must have all the specified labels.", - "valueSet" : "http://terminology.hl7.org/ValueSet/v3-PurposeOfUse" + "valueSet" : "https://nih-ncpi.github.io/ncpi-fhir-ig/ValueSet/nih-consent-codes" } }, { @@ -2182,8 +2182,19 @@ "path" : "Consent" }, { - "id" : "Consent.extension", - "path" : "Consent.extension", + "id" : "Consent.category", + "path" : "Consent.category", + "patternCodeableConcept" : { + "coding" : [{ + "system" : "http://terminology.hl7.org/CodeSystem/consentcategorycodes", + "code" : "research", + "display" : "Research Information Access" + }] + } + }, + { + "id" : "Consent.provision.extension", + "path" : "Consent.provision.extension", "slicing" : { "discriminator" : [{ "type" : "value", @@ -2194,20 +2205,20 @@ } }, { - "id" : "Consent.extension:diseaseAbbreviation", - "path" : "Consent.extension", - "sliceName" : "diseaseAbbreviation", + "id" : "Consent.provision.extension:diseaseUseLimitation", + "path" : "Consent.provision.extension", + "sliceName" : "diseaseUseLimitation", "short" : "Consent Code Disease Abbreviation", "min" : 0, "max" : "1", "type" : [{ "code" : "Extension", - "profile" : ["https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-consent-disease-abbreviation"] + "profile" : ["https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation"] }] }, { - "id" : "Consent.category", - "path" : "Consent.category", + "id" : "Consent.provision.purpose", + "path" : "Consent.provision.purpose", "binding" : { "strength" : "extensible", "valueSet" : "https://nih-ncpi.github.io/ncpi-fhir-ig/ValueSet/nih-consent-codes" From baa0bd35194f6295b695677142797e3fb1e0c0dd Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 19 Jun 2023 13:27:39 -0500 Subject: [PATCH 24/50] Study VS needed for example in the disease use limitation extension --- input/fsh/ValueSet-Mesh.fsh | 8 ++++++++ 1 file changed, 8 insertions(+) create mode 100644 input/fsh/ValueSet-Mesh.fsh diff --git a/input/fsh/ValueSet-Mesh.fsh b/input/fsh/ValueSet-Mesh.fsh new file mode 100644 index 00000000..468642ea --- /dev/null +++ b/input/fsh/ValueSet-Mesh.fsh @@ -0,0 +1,8 @@ +ValueSet: MeshTerms +Id: mesh-terms +Title: "MeSH Terms" +Description: "Example terms from Medical Subject Headings (MeSH) Ontology" +* ^version = "0.1.0" +* ^status = #draft +* ^experimental = false +* include codes from system $mesh From 60170e2154adcdd8e56ce1f4da74b5ef0722a972 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 19 Jun 2023 13:28:07 -0500 Subject: [PATCH 25/50] Rename to eliminate some publisher.jar errors --- ...CodeSystem-NcpiStudyType.fsh => CodeSystem-NcpiStudyTypes.fsh} | 0 1 file changed, 0 insertions(+), 0 deletions(-) rename input/fsh/{CodeSystem-NcpiStudyType.fsh => CodeSystem-NcpiStudyTypes.fsh} (100%) diff --git a/input/fsh/CodeSystem-NcpiStudyType.fsh b/input/fsh/CodeSystem-NcpiStudyTypes.fsh similarity index 100% rename from input/fsh/CodeSystem-NcpiStudyType.fsh rename to input/fsh/CodeSystem-NcpiStudyTypes.fsh From d4ffd481ca0ca49a7f79785369fe4edd04b4aef0 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 26 Jun 2023 10:41:20 -0500 Subject: [PATCH 26/50] Added note about R4/R5 versions that can be later expanded to include actual differences --- input/fsh/Profile-ResearchConsent.fsh | 22 +++++++++++----------- input/pagecontent/fhir_version.md | 1 + sushi-config.yaml | 1 + 3 files changed, 13 insertions(+), 11 deletions(-) create mode 100644 input/pagecontent/fhir_version.md diff --git a/input/fsh/Profile-ResearchConsent.fsh b/input/fsh/Profile-ResearchConsent.fsh index 951d8ace..09cba41b 100644 --- a/input/fsh/Profile-ResearchConsent.fsh +++ b/input/fsh/Profile-ResearchConsent.fsh @@ -31,16 +31,16 @@ Description: "Coding associated with limitation on what research can be performe // This profile exists in the resources directory until we have migrated all // R4 servers to a more recent version of HAPI. // -//Profile: ResearchStudyConsent -//Parent: Consent -//Id: research-study-consent -//Title: "Research Study Consent" -//Description: "A ResearchStudyConsent represents the core NIH Consent properties as they apply when consenting subjects to a research study" -//* ^version = "0.1.0" -//* ^status = #draft -//* category = http://terminology.hl7.org/CodeSystem/consentcategorycodes#research "Research Information Access" -//* provision.purpose from nih-consent-codes (extensible) -//* provision.extension contains ResearchDiseaseUseLimitation named diseaseUseLimitation 0..1 -//* provision.extension[diseaseUseLimitation] ^short = "Consent Code Disease Abbreviation" +// Profile: ResearchStudyConsent +// Parent: Consent +// Id: research-study-consent +// Title: "Research Study Consent" +// Description: "A ResearchStudyConsent represents the core NIH Consent properties as they apply when consenting subjects to a research study" +// * ^version = "0.1.0" +// * ^status = #draft +// * category = http://terminology.hl7.org/CodeSystem/consentcategorycodes#research "Research Information Access" +// * provision.purpose from nih-consent-codes (extensible) +// * provision.extension contains ResearchDiseaseUseLimitation named diseaseUseLimitation 0..1 +// * provision.extension[diseaseUseLimitation] ^short = "Consent Code Disease Abbreviation" //* extension[diseaseUseLimitation].value[x] only string diff --git a/input/pagecontent/fhir_version.md b/input/pagecontent/fhir_version.md new file mode 100644 index 00000000..1d223bed --- /dev/null +++ b/input/pagecontent/fhir_version.md @@ -0,0 +1 @@ +At this time we are focussing the majority of our efforts on mapping the research study components to R4, with the release of R5 in February 2023 we are including them in this iteration but on an experimental basis. Please see the research study documentation for in-depth mappings on a R5 version as well as a R4 version and the necessary extensions needed to ensure interoperability. We are not recommending or mandating an upgrade of your local FHIR instance at this point, if this changes we will communicate the next steps and rationale to all stakeholders. diff --git a/sushi-config.yaml b/sushi-config.yaml index abd8aa90..38711c3d 100755 --- a/sushi-config.yaml +++ b/sushi-config.yaml @@ -58,5 +58,6 @@ menu: Metadata Examples: example_study_metadata.html Raw Data Examples: example_raw_data.html Support: + FHIR Versions: fhir_version.html FHIR Spec: http://hl7.org/fhir/R4/index.html Downloads: downloads.html From bb67cf06c88c7628d85b6a18da94f015af772378 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 26 Jun 2023 17:07:46 -0500 Subject: [PATCH 27/50] Cleanup and light revision --- input/fsh/Profile-ResearchConsent.fsh | 2 +- ...tureDefinition-ncpi-research-consortium-intro.md | 8 ++++++-- ...uctureDefinition-research-study-consent-intro.md | 13 ++++++++++++- ...uctureDefinition-research-study-subject-intro.md | 10 ++++++++-- .../StructureDefinition-study-group-intro.md | 3 ++- .../StructureDefinition-research-study-consent.json | 2 +- 6 files changed, 30 insertions(+), 8 deletions(-) diff --git a/input/fsh/Profile-ResearchConsent.fsh b/input/fsh/Profile-ResearchConsent.fsh index 09cba41b..4021198c 100644 --- a/input/fsh/Profile-ResearchConsent.fsh +++ b/input/fsh/Profile-ResearchConsent.fsh @@ -35,7 +35,7 @@ Description: "Coding associated with limitation on what research can be performe // Parent: Consent // Id: research-study-consent // Title: "Research Study Consent" -// Description: "A ResearchStudyConsent represents the core NIH Consent properties as they apply when consenting subjects to a research study" +// Description: "A ResearchStudyConsent represents the core NIH Consent properties as they apply when consenting subjects to a research study." // * ^version = "0.1.0" // * ^status = #draft // * category = http://terminology.hl7.org/CodeSystem/consentcategorycodes#research "Research Information Access" diff --git a/input/pagecontent/StructureDefinition-ncpi-research-consortium-intro.md b/input/pagecontent/StructureDefinition-ncpi-research-consortium-intro.md index 96a8eea5..610813ab 100644 --- a/input/pagecontent/StructureDefinition-ncpi-research-consortium-intro.md +++ b/input/pagecontent/StructureDefinition-ncpi-research-consortium-intro.md @@ -1,7 +1,11 @@ -### Added Profile Restrictions +### Key Guidelines +For those studies which are a part of a research consortium, a single NCPI Research Consortium resource should be used to represent the consortium and all related studies should point to the consortium using the **sponsor** property. + +#### Added Profile Restrictions Each Consortium __must__ have: * a **meaningful name**. -It is strongly recommended: + +#### Recommended Practice * **common IDs** and **acronyms** be provided as **aliases**. * The **telecom** property can be used to provide a URL pointing to the consortium's website. \ No newline at end of file diff --git a/input/pagecontent/StructureDefinition-research-study-consent-intro.md b/input/pagecontent/StructureDefinition-research-study-consent-intro.md index 06a48090..74e0e3cf 100644 --- a/input/pagecontent/StructureDefinition-research-study-consent-intro.md +++ b/input/pagecontent/StructureDefinition-research-study-consent-intro.md @@ -1,3 +1,14 @@ -The ResearchStudyConsent profile is designed to conform to the same guidelines as found in the DbGaP/NIH Consent model. In this model, the consent's category contains an array of codes for each of the restrictions specified in the given consent. For instance, [HMB-NPU Consent](consent-hmb-npu-consent.html), there would be two codes added to the provision's purpose property: One for the HBM restriction and one for the NPU. Those restrictions must be selected from the CodeSystem, [NIH Consent](codesystem-nih-consent.html). For more disease specific restrictions, the code _DS_ is to be used along with a corresponding disease code(s) added via the [Research Disease Use Limitation](StructureDefinition-research-disease-use-limitation.html). +### Key Guidelines +The ResearchStudyConsent profile is designed to conform to the same guidelines as found in the DbGaP/NIH Consent model and is intended to be a singular resource that represents the consent signed by a group of participants in a research study. + +#### Added Profile Restrictions +* The consent's **category** *MUST* be set to the code, **research** from the system, http://terminology.hl7.org/CodeSystem/consentcategorycodes. +* All distinct consent restrictions should be added to the consent's provision.purpose as a separate coding from the [NIH Consent CodeSystem](codesystem-nih-consent.html). +* For disease specific restrictions, the code *DS* must be present in the purpose described above along with appropriate code(s) added via the [Research Disease Use Limitation Extension](StructureDefinition-research-disease-use-limitation.html). + +#### Recommended Practice +*This should go within the regular page content, but I want to wait until I have Katie's verbiage before working it in.* + +In this model, the consent's category contains an array of codes for each of the restrictions specified in the given consent. For instance, [HMB-NPU Consent](consent-hmb-npu-consent.html), there would be two codes added to the provision's purpose property: One for the HBM restriction and one for the NPU. Those restrictions must be selected from the CodeSystem, [NIH Consent](codesystem-nih-consent.html). For more disease specific restrictions, the code _DS_ is to be used along with a corresponding disease code(s) added via the [Research Disease Use Limitation](StructureDefinition-research-disease-use-limitation.html). Each ResearchStudyConsent resource is intended to be a singular resource that is used by all participants that were enrolled into the study under the particular consent agreement. As such, the model differs somewhat from the R4 Consent model. In this model, for each distinct consent agreement present in the study will be represented by a (ResearchStudySubject)(StructureDefinition-research-study-subject.html) which contains a single [Study Group](StructureDefinition-study-group.html) that may contain references to each participant consented by the relevant agreement. This ResearchStudySubject will contain a reference to the corresponding ResearchStudyConsent resource via the [Research Disease Use Limitation](StructureDefinition-research-disease-use-limitation.html). diff --git a/input/pagecontent/StructureDefinition-research-study-subject-intro.md b/input/pagecontent/StructureDefinition-research-study-subject-intro.md index d714e4d6..861b14e8 100644 --- a/input/pagecontent/StructureDefinition-research-study-subject-intro.md +++ b/input/pagecontent/StructureDefinition-research-study-subject-intro.md @@ -1,3 +1,9 @@ -Based on the [NCPI Research Study](StructureDefinition-ncpi-research-study.html) profile, this resource **must** have a _partOf_ property which points to the main NcpiResearchStudy resource. It **should** also use the [Research Study Subject Consent extension](StructureDefinition-research-study-subject-consent.html) to point to the corresponding consent resource. +### Key Guidelines +The NCPI ResearchStudySubject profile represents the different access control restrictions that may be found within a given study. This profile links the consent usage restrictions with the related list of participants together within the study in which the participants are enrolled. -Because it is derived from the NCPI Research Study profile, the resource's enrollment must contain a single [Study Group](StructureDefinition-study-group.html). \ No newline at end of file +#### Added Profile Restrictions +Based on the [NCPI Research Study](StructureDefinition-ncpi-research-study.html) profile, this resource: +* **must** have a _partOf_ property which points to the main NcpiResearchStudy resource. +* **should** also use the [Research Study Subject Consent extension](StructureDefinition-research-study-subject-consent.html) to point to the corresponding consent resource. + +Because it is derived from the NCPI Research Study profile, the resource's enrollment **must** contain a single [Study Group](StructureDefinition-study-group.html). \ No newline at end of file diff --git a/input/pagecontent/StructureDefinition-study-group-intro.md b/input/pagecontent/StructureDefinition-study-group-intro.md index 9884a78f..6c28b89f 100644 --- a/input/pagecontent/StructureDefinition-study-group-intro.md +++ b/input/pagecontent/StructureDefinition-study-group-intro.md @@ -1,7 +1,8 @@ +### Key Guidelines While there can be more than one StudyGroup per study, there **must** be one group representing the entire study enrollment. Patients can be members of more than one StudyGroup. -### Added Profile Restrictions +#### Added Profile Restrictions In order to ensure consistency across all NCPI research studies represented in FHIR, there are some additional requirements that are to be enforced: * The StudyGroup resource **must** be of type *person*. diff --git a/input/resources/StructureDefinition-research-study-consent.json b/input/resources/StructureDefinition-research-study-consent.json index ac7ceb75..f4184543 100644 --- a/input/resources/StructureDefinition-research-study-consent.json +++ b/input/resources/StructureDefinition-research-study-consent.json @@ -27,7 +27,7 @@ "use" : "work" }] }], - "description" : "A ResearchStudyConsent represents the core NIH Consent properties as they apply when consenting subjects to a research study", + "description" : "A ResearchStudyConsent represents the core NIH Consent properties as they apply when consenting subjects to a research study.", "fhirVersion" : "4.0.1", "mapping" : [{ "identity" : "workflow", From e5c90295828c9102fb62ac14f0a8e89edd38b3cb Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Wed, 28 Jun 2023 16:47:09 -0500 Subject: [PATCH 28/50] Added constraint to require extension when using DS code --- input/fsh/Profile-ResearchConsent.fsh | 6 +++--- ...tureDefinition-research-study-consent.json | 20 ++++++++++++++++--- 2 files changed, 20 insertions(+), 6 deletions(-) diff --git a/input/fsh/Profile-ResearchConsent.fsh b/input/fsh/Profile-ResearchConsent.fsh index 4021198c..a5623145 100644 --- a/input/fsh/Profile-ResearchConsent.fsh +++ b/input/fsh/Profile-ResearchConsent.fsh @@ -4,9 +4,9 @@ Expression: "valueString.matches('DS-[A-Z]+')" Severity: #error //https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-consent-disease-abbreviation -Invariant: completed-conset-code +Invariant: completed-consent-code Description: "If category is DS then there must be a ResearchConsentDiseaseAbbreviation" -Expression: "!category.where(coding.where(system&'|'&code = 'https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/nih-consent|DS').exists()).exists() or extension.where(url=https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-consent-disease-abbreviation).exists()" +Expression: "provision.purpose.where(code = 'DS').empty() or provision.extension.where(url='https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation').exists()" Severity: #error Extension: ResearchConsentDiseaseAbbreviation @@ -42,5 +42,5 @@ Description: "Coding associated with limitation on what research can be performe // * provision.purpose from nih-consent-codes (extensible) // * provision.extension contains ResearchDiseaseUseLimitation named diseaseUseLimitation 0..1 // * provision.extension[diseaseUseLimitation] ^short = "Consent Code Disease Abbreviation" - +// * obeys completed-consent-code //* extension[diseaseUseLimitation].value[x] only string diff --git a/input/resources/StructureDefinition-research-study-consent.json b/input/resources/StructureDefinition-research-study-consent.json index f4184543..8f451897 100644 --- a/input/resources/StructureDefinition-research-study-consent.json +++ b/input/resources/StructureDefinition-research-study-consent.json @@ -3,14 +3,14 @@ "id" : "research-study-consent", "text" : { "status" : "extensions", - "div" : "
\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n
NameFlagsCard.TypeDescription & Constraints\"doco\"
\".\"\".\" Consent 0..*ConsentA healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time
\".\"\".\"\".\" category 1..*CodeableConceptClassification of the consent statement - for indexing/retrieval
Required Pattern: At least the following
\".\"\".\"\".\"\".\" coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
\".\"\".\"\".\"\".\"\".\" system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/consentcategorycodes
\".\"\".\"\".\"\".\"\".\" code1..1codeSymbol in syntax defined by the system
Fixed Value: research
\".\"\".\"\".\"\".\"\".\" display1..1stringRepresentation defined by the system
Fixed Value: Research Information Access
\".\"\".\"\".\" provision
\".\"\".\"\".\"\".\" Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
\".\"\".\"\".\"\".\" diseaseUseLimitation 0..1CodeableConceptConsent Code Disease Abbreviation
URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation
Binding: MeSH Terms (example)
\".\"\".\"\".\"\".\" purpose 0..*CodingContext of activities covered by this rule
Binding: NIH Consent Code ValueSet (extensible)

\"doco\" Documentation for this format
" + "div" : "
\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n
NameFlagsCard.TypeDescription & Constraints\"doco\"
\".\"\".\" Consent C0..*ConsentA healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time
completed-consent-code: If category is DS then there must be a ResearchConsentDiseaseAbbreviation
\".\"\".\"\".\" category 1..*CodeableConceptClassification of the consent statement - for indexing/retrieval
Required Pattern: At least the following
\".\"\".\"\".\"\".\" coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
\".\"\".\"\".\"\".\"\".\" system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/consentcategorycodes
\".\"\".\"\".\"\".\"\".\" code1..1codeSymbol in syntax defined by the system
Fixed Value: research
\".\"\".\"\".\"\".\"\".\" display1..1stringRepresentation defined by the system
Fixed Value: Research Information Access
\".\"\".\"\".\" provision
\".\"\".\"\".\"\".\" Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
\".\"\".\"\".\"\".\" diseaseUseLimitation 0..1CodeableConceptConsent Code Disease Abbreviation
URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation
Binding: MeSH Terms (example)
\".\"\".\"\".\"\".\" purpose 0..*CodingContext of activities covered by this rule
Binding: NIH Consent Code ValueSet (extensible)

\"doco\" Documentation for this format
" }, "url" : "https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-consent", "version" : "0.2.0", "name" : "ResearchStudyConsent", "title" : "Research Study Consent", "status" : "draft", - "date" : "2023-06-19T10:28:49-05:00", + "date" : "2023-06-28T14:05:37-05:00", "publisher" : "NCPI FHIR Working Group", "contact" : [{ "name" : "NCPI FHIR Working Group", @@ -155,6 +155,13 @@ "expression" : "patient.exists() or scope.coding.where(system='something' and code='treatment').exists().not()", "xpath" : "exists(f:patient) or not(exists(f:scope/f:coding[f:system/@value='something' and f:code/@value='treatment'])))", "source" : "http://hl7.org/fhir/StructureDefinition/Consent" + }, + { + "key" : "completed-consent-code", + "severity" : "error", + "human" : "If category is DS then there must be a ResearchConsentDiseaseAbbreviation", + "expression" : "provision.purpose.where(code = 'DS').empty() or provision.extension.where(url='https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation').exists()", + "source" : "https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-consent" }], "isModifier" : false, "isSummary" : false, @@ -2179,7 +2186,14 @@ "differential" : { "element" : [{ "id" : "Consent", - "path" : "Consent" + "path" : "Consent", + "constraint" : [{ + "key" : "completed-consent-code", + "severity" : "error", + "human" : "If category is DS then there must be a ResearchConsentDiseaseAbbreviation", + "expression" : "provision.purpose.where(code = 'DS').empty() or provision.extension.where(url='https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation').exists()", + "source" : "https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-consent" + }] }, { "id" : "Consent.category", From 00537b1584d32355057cdea66d7c5923d007fa3f Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Wed, 28 Jun 2023 16:47:37 -0500 Subject: [PATCH 29/50] Additional refinement to the NCPI Research Study Profile page docs --- input/fsh/Profile-NCPI-ResearchStudy.fsh | 3 +- ...ureDefinition-ncpi-research-study-intro.md | 37 +++++++++++++++---- 2 files changed, 32 insertions(+), 8 deletions(-) diff --git a/input/fsh/Profile-NCPI-ResearchStudy.fsh b/input/fsh/Profile-NCPI-ResearchStudy.fsh index d2370821..3b61f07b 100644 --- a/input/fsh/Profile-NCPI-ResearchStudy.fsh +++ b/input/fsh/Profile-NCPI-ResearchStudy.fsh @@ -2,10 +2,11 @@ Profile: NcpiResearchStudy Parent: ResearchStudy Id: ncpi-research-study Title: "NCPI Research Study" -Description: "The NCPI Research Study is based upon the core FHIR ResearchStudy resource and shall act as the umbrella under which all study resources can ultimately be found. For the purposes of interoperability, some restrictions have been made to enforce a common mechanism for describing enrollment and provide a simple means for summarizing subject count and consent group membership." +Description: "The NCPI Research Study is based upon the core HL7 FHIR ResearchStudy resource (R4) and shall act as the umbrella under which all study resources can ultimately be found." * ^version = "0.0.1" * ^status = #draft * category.coding = $ncpi#StudyCohort "Study Cohort" * enrollment 1..1 * enrollment only Reference(StudyGroup) * sponsor only Reference(ResearchConsortium) +* principalInvestigator only Reference(Practitioner) diff --git a/input/pagecontent/StructureDefinition-ncpi-research-study-intro.md b/input/pagecontent/StructureDefinition-ncpi-research-study-intro.md index 4b3908b9..05654f73 100644 --- a/input/pagecontent/StructureDefinition-ncpi-research-study-intro.md +++ b/input/pagecontent/StructureDefinition-ncpi-research-study-intro.md @@ -1,10 +1,33 @@ +For the purposes of interoperability, some restrictions have been made to enforce a common mechanism for describing enrollment and provide a simple means for summarizing subject count as well as access control through the main (parent) consent groups. In addition, we are providing some recommended practices for the common data elements required for submission. + +Please see the research study documentation for in-depth mappings on the R4 version and the necessary extensions needed to ensure interoperability. + ### Added Profile Restrictions -In order to ensure consistency across all NCPI research studies represented in FHIR, there are some additional requirements that are to be enforced: +To ensure consistency across all NCPI research studies represented in FHIR, there are some additional requirements which must be enforced. These requirements are derived from the Differential Table which can be found in the 28.4.1.3 section of this document. + +#### The following requirements are true for all NCPI Research Studies: +* enrollment **must** contain 1 reference of type, [Study Group](StructureDefinition-study-group.html). +* category **must** contain the Coding from NCPI [StudyCohort](CodeSystem-ncpi.html). +* each study **should** have its _accession ID_ added as an identifier. +* each study **should** have its _study name_ as the title. +* for those studies which exist as part of a larger study, the parent study **should** be referenced in the study's _partOf_ property. +* *principalInvestigator* **must** be of type _Practitioner_ if present. + +### General Study Guideleines +To ensure consistency across all NCPI research studies represented in FHIR, there are some additional elements which should be included if applicable to your study. + +#### Recommended Elements +A recommended element is not mandatory for validation but will potentially interfere with data analysis if not included. +* A reasonably complete _study description_ **should** be provided in the _description_ property. +* All relevant _diseases or study focus_ **should** be enumerated as terms from relevant ontologies in the _condition_ property. +* _Attribution details_ such as principal investigators, grant numbers, etc. **should** be enumerated inside the _relatedArtifact_ property. + +### Optional Elements +An optional element is one which will help provide additional context to the research study but will not affect data analysis. +* It is highly recommended that each _study weblink_ be enumerated inside the _relatedArtifact_ property. +* Any _citations_ **should** be enumerated in the _relatedArtifact_ property. +* Any other _relevant documents_ **should** be enumerated in the _relatedArtifact_ property. -The following requirements are true for all NCPI Research Studies: -* enrollment **must** contain 1 or more reference -* enrollment **must** only reference NCPI StudyGroup resources -* category must contain the Coding from NCPI [StudyCohort](CodeSystem-ncpi.html) +For a more detailed view of these elements as well as the recommended FHIR mappings please see the research study documentation. -### Recommended Practices -In order to support interoperability, whenever possible, the NCPI Research Study resource should have one or more Codings provided for the Study's condition property indicating the disease or phenotype's that were interrogated during the study's execution. \ No newline at end of file +Each NCPI Research must have at least one NCPI Study Group which must, at the very least, indicate the total number of patients enrolled at the time the data was loaded into FHIR. Additional Study Groups can be present indicating relevant groupings of subjects, such as for different consent groups. From 791cc16399326f78d09cb8f0bb4ae7d59456539e Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Thu, 20 Jul 2023 12:14:37 -0500 Subject: [PATCH 30/50] A bit more clarification around accession ID --- .../StructureDefinition-ncpi-research-study-intro.md | 4 ++-- 1 file changed, 2 insertions(+), 2 deletions(-) diff --git a/input/pagecontent/StructureDefinition-ncpi-research-study-intro.md b/input/pagecontent/StructureDefinition-ncpi-research-study-intro.md index 05654f73..458291c5 100644 --- a/input/pagecontent/StructureDefinition-ncpi-research-study-intro.md +++ b/input/pagecontent/StructureDefinition-ncpi-research-study-intro.md @@ -8,7 +8,7 @@ To ensure consistency across all NCPI research studies represented in FHIR, ther #### The following requirements are true for all NCPI Research Studies: * enrollment **must** contain 1 reference of type, [Study Group](StructureDefinition-study-group.html). * category **must** contain the Coding from NCPI [StudyCohort](CodeSystem-ncpi.html). -* each study **should** have its _accession ID_ added as an identifier. +* each study **should** have its _accession ID_ added as an identifier. This is an identifier provided by DbGAP or other organization which represents a common identifier recognized by similar research groups. * each study **should** have its _study name_ as the title. * for those studies which exist as part of a larger study, the parent study **should** be referenced in the study's _partOf_ property. * *principalInvestigator* **must** be of type _Practitioner_ if present. @@ -30,4 +30,4 @@ An optional element is one which will help provide additional context to the res For a more detailed view of these elements as well as the recommended FHIR mappings please see the research study documentation. -Each NCPI Research must have at least one NCPI Study Group which must, at the very least, indicate the total number of patients enrolled at the time the data was loaded into FHIR. Additional Study Groups can be present indicating relevant groupings of subjects, such as for different consent groups. +Each NCPI Research must have at least one NCPI Study Group which must, at the very least, indicate the total number of patients enrolled at the time the data was loaded into FHIR. Additional Study Groups can be present indicating relevant groupings of subjects. From 08a8cf092735a2b9220230d2120f66e6ca03f4ac Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Thu, 20 Jul 2023 16:44:11 -0500 Subject: [PATCH 31/50] Further refinement of the language present on structure-definition pages --- input/fsh/Profile-ResearchConsortium.fsh | 2 +- input/pagecontent/StructureDefinition-study-group-intro.md | 5 +++-- input/pagecontent/StructureDefinition-study-group-notes.md | 2 +- 3 files changed, 5 insertions(+), 4 deletions(-) diff --git a/input/fsh/Profile-ResearchConsortium.fsh b/input/fsh/Profile-ResearchConsortium.fsh index 7a2b0acb..9674767c 100644 --- a/input/fsh/Profile-ResearchConsortium.fsh +++ b/input/fsh/Profile-ResearchConsortium.fsh @@ -2,7 +2,7 @@ Profile: ResearchConsortium Parent: Organization Id: ncpi-research-consortium Title: "Research Consortium" -Description: "A FHIR Organization representing a single consortium of which one or more NCPI Research Studies is a member" +Description: "A FHIR Organization representing a single consortium of which one or more NCPI Research Studies is a member." * ^version = "0.1.0" * ^status = #draft * name 1..1 \ No newline at end of file diff --git a/input/pagecontent/StructureDefinition-study-group-intro.md b/input/pagecontent/StructureDefinition-study-group-intro.md index 6c28b89f..d6cb1785 100644 --- a/input/pagecontent/StructureDefinition-study-group-intro.md +++ b/input/pagecontent/StructureDefinition-study-group-intro.md @@ -8,8 +8,9 @@ In order to ensure consistency across all NCPI research studies represented in F * The StudyGroup resource **must** be of type *person*. * The StudyGroup resource **must** be *actual*. * The StudyGroup resource **must** have a quantity. -* The StudyGroup **must** include SNOMED#44807982 as one of it's [Codings](FHIR_Basics.html#coding). +* The StudyGroup **must** include the NCIT Code, C142710 as one of it's [Codings](FHIR_Basics.html#coding). * When enumerating membership, the StudyGroup resource **must** have only Patients as members. -A StudyGroup should exist alongside any row level data, but these resources can also exist outside a restricted FHIR server to provide access to non-row level information, such as the number of individuals that can be found in a given study. +A StudyGroup should exist alongside any row level data, but these resources can also exist outside a restricted FHIR server to provide access to non-row level information. +At the very least, the Study Group should provide the count of subjects it represents. diff --git a/input/pagecontent/StructureDefinition-study-group-notes.md b/input/pagecontent/StructureDefinition-study-group-notes.md index 40141b70..55b66459 100644 --- a/input/pagecontent/StructureDefinition-study-group-notes.md +++ b/input/pagecontent/StructureDefinition-study-group-notes.md @@ -1,2 +1,2 @@ -At the very least, there should be one StudyGroup that contains all members of the study. For those studies with more than one consent type, additional StudyGroups can be added. +For top level studies, the group should represent the entirety of the study. For sub-studies and consent groups, the Study Group should contain all members of that study or consent grouping. From a4bc7825889d24b8c0cbaabe8cdadce9ee37ad3b Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 24 Jul 2023 11:54:16 -0500 Subject: [PATCH 32/50] Update study notes to clarify relationship with study and study group --- .../StructureDefinition-ncpi-research-study-notes.md | 2 +- 1 file changed, 1 insertion(+), 1 deletion(-) diff --git a/input/pagecontent/StructureDefinition-ncpi-research-study-notes.md b/input/pagecontent/StructureDefinition-ncpi-research-study-notes.md index 411ee95c..72277e96 100644 --- a/input/pagecontent/StructureDefinition-ncpi-research-study-notes.md +++ b/input/pagecontent/StructureDefinition-ncpi-research-study-notes.md @@ -1,4 +1,4 @@ -Each NCPI Research must have at least one NCPI Study Group which must, at the very least indicate the total number of patients enrolled at the time the data was loaded into FHIR. Additional Study Groups can be present indicating relevant groupings of subjects, such as for different consent groups. +As mentioned in the section, "Added Profile Restrictions" above, each NCPI Research must have one NCPI [Study Group](StructureDefinition-study-group.html) which must, at the very least, indicate the total number of patients enrolled at the time the data was loaded into FHIR. ### Practices for Summary Only Resources For Studies loaded into Summary Only FHIR servers, the Study's Study Group resources **must** have the quantity. This promotes findability by enabling researches without current access to the study's row-level data to get basic study details including the different subject counts. From aa22326b2eabf99cf96cb3d36b91f2dc7b567d44 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 31 Jul 2023 17:15:19 -0500 Subject: [PATCH 33/50] Added first pass of studyDesign extension --- input/fsh/Profile-NCPI-ResearchStudy.fsh | 17 +++++++++++++++++ 1 file changed, 17 insertions(+) diff --git a/input/fsh/Profile-NCPI-ResearchStudy.fsh b/input/fsh/Profile-NCPI-ResearchStudy.fsh index 3b61f07b..07a66e84 100644 --- a/input/fsh/Profile-NCPI-ResearchStudy.fsh +++ b/input/fsh/Profile-NCPI-ResearchStudy.fsh @@ -1,3 +1,19 @@ +ValueSet: StudyDesign +Id: study-design +Title: "Study Design" +Description: "This is a set of terms for study design characteristics." +* ^version = "0.1.0" +* ^status = #draft +* ^experimental = false +* include codes from system https://hl7.org/fhir/codesystem-study-design.html + +Extension: ResearchStudyDesign +Id: research-study-design +Title: "Research Study Design" +Description: "Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc." +* value[x] only CodeableConcept +* valueCodeableConcept from study-design (example) + Profile: NcpiResearchStudy Parent: ResearchStudy Id: ncpi-research-study @@ -10,3 +26,4 @@ Description: "The NCPI Research Study is based upon the core HL7 FHIR ResearchSt * enrollment only Reference(StudyGroup) * sponsor only Reference(ResearchConsortium) * principalInvestigator only Reference(Practitioner) +* extension contains ResearchStudyDesign named studyDesign 0..* From 138f7ac9edaca6c4991727a08c79272d451aec46 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 31 Jul 2023 17:15:40 -0500 Subject: [PATCH 34/50] Added tables to clarify mappings --- ...ureDefinition-ncpi-research-study-intro.md | 36 +++++++++++-------- 1 file changed, 22 insertions(+), 14 deletions(-) diff --git a/input/pagecontent/StructureDefinition-ncpi-research-study-intro.md b/input/pagecontent/StructureDefinition-ncpi-research-study-intro.md index 458291c5..4edbc0f4 100644 --- a/input/pagecontent/StructureDefinition-ncpi-research-study-intro.md +++ b/input/pagecontent/StructureDefinition-ncpi-research-study-intro.md @@ -3,7 +3,7 @@ For the purposes of interoperability, some restrictions have been made to enforc Please see the research study documentation for in-depth mappings on the R4 version and the necessary extensions needed to ensure interoperability. ### Added Profile Restrictions -To ensure consistency across all NCPI research studies represented in FHIR, there are some additional requirements which must be enforced. These requirements are derived from the Differential Table which can be found in the 28.4.1.3 section of this document. +To ensure consistency across all NCPI research studies represented in FHIR, there are some additional requirements which must be enforced. These requirements are derived from the [Differential Table](#profile) section of this document. #### The following requirements are true for all NCPI Research Studies: * enrollment **must** contain 1 reference of type, [Study Group](StructureDefinition-study-group.html). @@ -13,21 +13,29 @@ To ensure consistency across all NCPI research studies represented in FHIR, ther * for those studies which exist as part of a larger study, the parent study **should** be referenced in the study's _partOf_ property. * *principalInvestigator* **must** be of type _Practitioner_ if present. -### General Study Guideleines -To ensure consistency across all NCPI research studies represented in FHIR, there are some additional elements which should be included if applicable to your study. +| NCPI Common Data Elements | HL7 FHIR (R4) Element | Notes | +| --- | --- | --- | +| Accession # | identifier | Accession IDs from dbGaP, etc should be added as identifiers with a meaningful system | +| Study name | title | | +| Substudies | partOf | Substudies other than consent based organization should reference the parent NCPI Research Study using the partOf reference | -#### Recommended Elements -A recommended element is not mandatory for validation but will potentially interfere with data analysis if not included. -* A reasonably complete _study description_ **should** be provided in the _description_ property. -* All relevant _diseases or study focus_ **should** be enumerated as terms from relevant ontologies in the _condition_ property. -* _Attribution details_ such as principal investigators, grant numbers, etc. **should** be enumerated inside the _relatedArtifact_ property. +### Recommended Practices +To ensure consistency across all NCPI research studies represented in FHIR, there are some additional elements which should be included if applicable to your study. A recommended element is one that is important and will likely have value for those trying to understand the study's purpose and usefulness but not essential for validation against the profile. Those elements labeled as optional are not central to the fundamental understanding of the study's content but may play a key role in a study being *findable*. -### Optional Elements -An optional element is one which will help provide additional context to the research study but will not affect data analysis. -* It is highly recommended that each _study weblink_ be enumerated inside the _relatedArtifact_ property. -* Any _citations_ **should** be enumerated in the _relatedArtifact_ property. -* Any other _relevant documents_ **should** be enumerated in the _relatedArtifact_ property. +#### Common Data Elements + +| NCPI COmmon Data Elements | HL7 FHIR (R4) Element | Recommended or Optional | Notes | +| --- | --- | --- | --- | +| Study description | description | Recommended | | +| Disease/focus | condition | Recommended | Should also have one or more Codings provided, indicating the disease or phenotypes that were interrogated during the study’s execution | +| Attribution | relatedArtifact | Recommended | This can include, but not limited to; principal investigators, grant numbers, etc. | +| Study weblinks | relatedArfifact | Optional | These elements fall under the StudyDescription element located in the [Added Profile Restrictions](#added-profile-restrictions) section of this document. | +| Study design | [studyDesign](StructureDefinition-research-study-design.html) | Optional | These elements fall under the StudyDescription element located in the [Added Profile Restrictions](#added-profile-restrictions) section of this document. | +| Study type | [studyDesign](StructureDefinition-research-study-design.html) | Optional | These elements fall under the StudyDescription element located in the [Added Profile Restrictions](#added-profile-restrictions) section of this document. | +| Citation | relatedArtifact | Optional | | +| Study documents | relatedArtifact | Optional | | For a more detailed view of these elements as well as the recommended FHIR mappings please see the research study documentation. -Each NCPI Research must have at least one NCPI Study Group which must, at the very least, indicate the total number of patients enrolled at the time the data was loaded into FHIR. Additional Study Groups can be present indicating relevant groupings of subjects. +#### Population Details +Each NCPI Research must have one [Study Group](StructureDefinition-study-group.html) which must, at the very least, indicate the total number of patients enrolled at the time the data was loaded into FHIR. From 21402e7ff873c01aea3e55e6301f6a78a2fc9470 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Tue, 1 Aug 2023 10:19:19 -0500 Subject: [PATCH 35/50] Force install to be sushi 2.10 since the current version is 3 which is incompatible with our code --- .github/workflows/continuous_integration.yml | 2 +- .github/workflows/deploy_preview.yml | 2 +- .github/workflows/publish.yml | 2 +- 3 files changed, 3 insertions(+), 3 deletions(-) diff --git a/.github/workflows/continuous_integration.yml b/.github/workflows/continuous_integration.yml index 73242d1f..8efc62c7 100644 --- a/.github/workflows/continuous_integration.yml +++ b/.github/workflows/continuous_integration.yml @@ -34,7 +34,7 @@ jobs: - name: Install SUSHI and add FSH definitions run: | - npm install -g fsh-sushi + npm install -g fsh-sushi@v2.10.2 sushi . - name: Update IG publisher diff --git a/.github/workflows/deploy_preview.yml b/.github/workflows/deploy_preview.yml index 76a81cfd..1a2f125b 100644 --- a/.github/workflows/deploy_preview.yml +++ b/.github/workflows/deploy_preview.yml @@ -30,7 +30,7 @@ jobs: - name: 🛠 Install SUSHI and add FSH definitions run: | - npm install -g fsh-sushi + npm install -g fsh-sushi@v2.10.2 sushi . - name: ⬆️ Update IG publisher diff --git a/.github/workflows/publish.yml b/.github/workflows/publish.yml index 5be15656..da65c354 100644 --- a/.github/workflows/publish.yml +++ b/.github/workflows/publish.yml @@ -36,7 +36,7 @@ jobs: - name: Install SUSHI and add FSH definitions run: | - npm install -g fsh-sushi + npm install -g fsh-sushi@v2.10.2 sushi . - name: Update IG publisher From bed07c60b957a973c9f22e8f194ca7b294952005 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Tue, 1 Aug 2023 10:46:22 -0500 Subject: [PATCH 36/50] Trying to stay within 2 but getting the most recent minor version. --- .github/workflows/continuous_integration.yml | 2 +- .github/workflows/deploy_preview.yml | 2 +- .github/workflows/publish.yml | 2 +- 3 files changed, 3 insertions(+), 3 deletions(-) diff --git a/.github/workflows/continuous_integration.yml b/.github/workflows/continuous_integration.yml index 8efc62c7..6aa28b0f 100644 --- a/.github/workflows/continuous_integration.yml +++ b/.github/workflows/continuous_integration.yml @@ -34,7 +34,7 @@ jobs: - name: Install SUSHI and add FSH definitions run: | - npm install -g fsh-sushi@v2.10.2 + npm install -g fsh-sushi@^2.10.2 sushi . - name: Update IG publisher diff --git a/.github/workflows/deploy_preview.yml b/.github/workflows/deploy_preview.yml index 1a2f125b..f5e1de69 100644 --- a/.github/workflows/deploy_preview.yml +++ b/.github/workflows/deploy_preview.yml @@ -30,7 +30,7 @@ jobs: - name: 🛠 Install SUSHI and add FSH definitions run: | - npm install -g fsh-sushi@v2.10.2 + npm install -g fsh-sushi@^2.10.2 sushi . - name: ⬆️ Update IG publisher diff --git a/.github/workflows/publish.yml b/.github/workflows/publish.yml index da65c354..68e8d026 100644 --- a/.github/workflows/publish.yml +++ b/.github/workflows/publish.yml @@ -36,7 +36,7 @@ jobs: - name: Install SUSHI and add FSH definitions run: | - npm install -g fsh-sushi@v2.10.2 + npm install -g fsh-sushi@^2.10.2 sushi . - name: Update IG publisher From ad5d3ea4b86acd4bd00f929de870b11c1cf51693 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Wed, 2 Aug 2023 15:43:46 -0500 Subject: [PATCH 37/50] Added extension for studyDesign codes and example usage --- input/fsh/Alias.fsh | 1 + input/fsh/CodeSystem-DbGAPStudyDesign.fsh | 25 +++++++++++++++++++++++ input/fsh/Example-CMG-ResearchStudy.fsh | 4 ++-- 3 files changed, 28 insertions(+), 2 deletions(-) create mode 100755 input/fsh/CodeSystem-DbGAPStudyDesign.fsh diff --git a/input/fsh/Alias.fsh b/input/fsh/Alias.fsh index 35c1e1f7..ae74923d 100755 --- a/input/fsh/Alias.fsh +++ b/input/fsh/Alias.fsh @@ -37,6 +37,7 @@ Alias: $refseq = http://www.ncbi.nlm.nih.gov/refseq Alias: $varnomen = http://varnomen.hgvs.org Alias: $umls = https://uts.nlm.nih.gov/uts/umls Alias: $nihcc = https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/nih-consent +Alias: $studydesign = https://dbgap-api.ncbi.nlm.nih.gov/fhir/x1/CodeSystem/ResearchStudy-StudyDesign // ValueSet Alias: $v3-FamilyMember = http://terminology.hl7.org/ValueSet/v3-FamilyMember diff --git a/input/fsh/CodeSystem-DbGAPStudyDesign.fsh b/input/fsh/CodeSystem-DbGAPStudyDesign.fsh new file mode 100755 index 00000000..4156d1fb --- /dev/null +++ b/input/fsh/CodeSystem-DbGAPStudyDesign.fsh @@ -0,0 +1,25 @@ +CodeSystem: DbGapStudyDesign +Id: dbgap-study-design +Title: "dbGaP Study Design" +Description: "StudyDesign codes from dbGaP FHIR Service pulled Aug 2023." +* ^url = $studydesign +* ^status = #draft +* ^experimental = false +* ^caseSensitive = true +* ^content = #fragment +* ^count = 15 +* #Case-Set "Case Set" +* #Case-Control "Case-Control" +* #Clinical-Genetic-Testing "Clinical Genetic Testing" +* #Clinical-Trial "Clinical Trial" +* #Collection "Collection" +* #Control-Set "Control Set" +* #Cross-Sectional "Cross-Sectional" +* #Family/Twin/Trios "Family/Twin/Trios" +* #Interventional "Interventional" +* #Mendelian "Mendelian" +* #Metagenomics "Metagenomics" +* #Methods "Methods" +* #Prospective-Longitudinal-Cohort "Prospective Longitudinal Cohort" +* #Tumor-vs-Matched-Normal "Tumor vs. Matched-Normal" +* #Xenograft "Xenograft" \ No newline at end of file diff --git a/input/fsh/Example-CMG-ResearchStudy.fsh b/input/fsh/Example-CMG-ResearchStudy.fsh index 4c65b312..07752b39 100644 --- a/input/fsh/Example-CMG-ResearchStudy.fsh +++ b/input/fsh/Example-CMG-ResearchStudy.fsh @@ -41,7 +41,6 @@ Description: "The Centers for Mendelian Genomics project uses next-generation se * system = $ncpi * code = #StudyCohort * display = "Study Cohort" -* primaryPurposeType = $ncpi-study-types#Mixed "Mixed" * focus[+] = $mondo#MONDO:0016054 "cerebral malformation" * focus[+] = $hpo#HP:0030853 "Heterotaxy" * focus[+] = $mondo#MONDO:0016033 "Cornelia de Lange syndrome" @@ -56,7 +55,8 @@ Description: "The Centers for Mendelian Genomics project uses next-generation se * citation = "Gonzaga-Jauregui C, Lupski JR, Gibbs RA. Human genome sequencing in health and disease. Annu Rev Med. 2012;63:35-61. doi: 10.1146/annurev-med-051010-162644. PMID: 22248320; PMCID: PMC3656720." * url = "https://pubmed.ncbi.nlm.nih.gov/22248320/" * enrollment = Reference(cmg-research-study-bhcmg-group) - +* extension[studyDesign].valueCodeableConcept.coding[0] = $studydesign#Mendelian "Mendelian" +* extension[studyDesign].valueCodeableConcept.coding[1] = $ncpi-study-types#Mixed "Mixed" Instance: cmg-research-study-bhcmg-group InstanceOf: StudyGroup From df5cfdb34396a6979cf8586d3416b115fccc0c6e Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Fri, 18 Aug 2023 16:34:02 -0500 Subject: [PATCH 38/50] First pass at the research study example content --- input/fsh/Example-CMG-ResearchStudy.fsh | 23 +- input/fsh/Example-ResearchStudy.fsh | 7 +- input/fsh/Profile-NCPI-ResearchStudy.fsh | 42 ++- input/fsh/Profile-ResearchConsortium.fsh | 5 +- .../images/bh-cmg-research-study-example.png | Bin 0 -> 657394 bytes .../example-research-study-baylor-cmg.md | 274 ++++++++++++++++++ input/pagecontent/research_study.md | 2 + 7 files changed, 344 insertions(+), 9 deletions(-) create mode 100755 input/images/bh-cmg-research-study-example.png create mode 100644 input/pagecontent/example-research-study-baylor-cmg.md diff --git a/input/fsh/Example-CMG-ResearchStudy.fsh b/input/fsh/Example-CMG-ResearchStudy.fsh index 07752b39..d6e9db39 100644 --- a/input/fsh/Example-CMG-ResearchStudy.fsh +++ b/input/fsh/Example-CMG-ResearchStudy.fsh @@ -42,18 +42,25 @@ Description: "The Centers for Mendelian Genomics project uses next-generation se * code = #StudyCohort * display = "Study Cohort" * focus[+] = $mondo#MONDO:0016054 "cerebral malformation" -* focus[+] = $hpo#HP:0030853 "Heterotaxy" -* focus[+] = $mondo#MONDO:0016033 "Cornelia de Lange syndrome" +* focus[+].coding[0] = $hpo#HP:0030853 "Heterotaxy" +* focus[=].coding[1] = $mesh#D059446 "Heterotaxy Syndrome" +* focus[+].coding[0] = $mondo#MONDO:0016033 "Cornelia de Lange syndrome" +* focus[=].coding[1] = $mesh#D003635 "De Lange Syndrome" // This particular study doesn't have a specific * relatedArtifact[0] * type = #derived-from * label = "DbGaP" - * url = "phs000711" + * display = "phs000711" + * url = "https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000711" * relatedArtifact[+] * type = #documentation * label = "Citation" * citation = "Gonzaga-Jauregui C, Lupski JR, Gibbs RA. Human genome sequencing in health and disease. Annu Rev Med. 2012;63:35-61. doi: 10.1146/annurev-med-051010-162644. PMID: 22248320; PMCID: PMC3656720." - * url = "https://pubmed.ncbi.nlm.nih.gov/22248320/" + * document.url = "https://pubmed.ncbi.nlm.nih.gov/22248320/" +* relatedArtifact[+] + * type = #documentation + * label = "Website" + * document.url = "https://mendeliangenomics.org/" * enrollment = Reference(cmg-research-study-bhcmg-group) * extension[studyDesign].valueCodeableConcept.coding[0] = $studydesign#Mendelian "Mendelian" * extension[studyDesign].valueCodeableConcept.coding[1] = $ncpi-study-types#Mixed "Mixed" @@ -86,6 +93,9 @@ InstanceOf: ResearchStudySubject Title: "Participants consented under HMB-NPU" Usage: #example Description: "CMG Consent Group, Health/Medical/Biomedical + Not for profit use" +* identifier[0] + * system = "http://mendelian.org/fhir" + * value = "BH-CMG-HMB-NPU" * title = "BH-CMG HMB-NPU Consent Study Subject" * description = "CMG Consent Group, Health/Medical/Biomedical + Not for profit use" * status = #completed @@ -124,13 +134,16 @@ InstanceOf: ResearchStudySubject Title: "Participants consented under HMB-IRB-NPU" Usage: #example Description: "CMG Consent Group, HMB-IRB-NPU" +* identifier[0] + * system = "http://mendelian.org/fhir" + * value = "BH-CMG-HMB-IRB-NPU" * title = "BH-CMG HMB-IRB-NPU Consent Study Subject" * status = #completed * partOf = Reference(cmg-research-study-bhcmg) * extension[consent].valueReference = Reference(hmb-irb-npu-consent) * enrollment = Reference(cmg-research-study-bhcmg-group-hmb-irb-npu) -Instance: cmg-research-study-bhcmg-group-hmb-irb-npu +Instance: cmg-research-study-bhcmg-consent-group-hmb-irb-npu InstanceOf: StudyGroup Title: "Participants consented under HMB-IRB-NPU" Usage: #example diff --git a/input/fsh/Example-ResearchStudy.fsh b/input/fsh/Example-ResearchStudy.fsh index 56030427..5ffb21c7 100644 --- a/input/fsh/Example-ResearchStudy.fsh +++ b/input/fsh/Example-ResearchStudy.fsh @@ -25,6 +25,9 @@ Instance: ncpi-research-study-01 InstanceOf: NcpiResearchStudy Usage: #example Description: "An example research study" +* identifier[0] + * system = "http://example.com/fhir" + * value = "exammple-study" * title = "Example research study" * status = #completed * primaryPurposeType = #diagnostic @@ -53,11 +56,13 @@ Description: "Example of Disease Specific Consent resource" * provision.extension[diseaseUseLimitation].valueCodeableConcept.coding = $mesh#D000082882 "Bicuspid Aortic Valve Disease" //* extension[diseaseAbbreviation].valueString = "DS-BAV" - Instance: ncpi-research-study-subject-01 InstanceOf: ResearchStudySubject Usage: #example Description: "An example of an R4 Research Study Subject which connects subjects to a research study and their consent" +* identifier[0] + * system = "http://example.com/fhir" + * value = "Example-Research-Study-Subject-GRU" * title = "Example research study subject" * status = #completed * partOf = Reference(ncpi-research-study-01) diff --git a/input/fsh/Profile-NCPI-ResearchStudy.fsh b/input/fsh/Profile-NCPI-ResearchStudy.fsh index 07a66e84..bc62743e 100644 --- a/input/fsh/Profile-NCPI-ResearchStudy.fsh +++ b/input/fsh/Profile-NCPI-ResearchStudy.fsh @@ -19,11 +19,49 @@ Parent: ResearchStudy Id: ncpi-research-study Title: "NCPI Research Study" Description: "The NCPI Research Study is based upon the core HL7 FHIR ResearchStudy resource (R4) and shall act as the umbrella under which all study resources can ultimately be found." +* ^description = "The NCPI Research Study is based upon the core HL7 FHIR ResearchStudy resource (R4) and shall act as the umbrella under which all study resources can ultimately be found." * ^version = "0.0.1" * ^status = #draft +* identifier 1..* +* identifier ^short = "Accession IDs from dbGaP, etc." +* title ^short = "Study Title (Strongly Recommended)" +* description ^short = "Study Description (Recommended)" +* category.coding ^short = "Indicate this is an NCPI Research Study" * category.coding = $ncpi#StudyCohort "Study Cohort" +* enrollment ^short = "Study Participants" * enrollment 1..1 * enrollment only Reference(StudyGroup) -* sponsor only Reference(ResearchConsortium) -* principalInvestigator only Reference(Practitioner) +* sponsor ^short = "Consortium or other group the study is a member" +* sponsor only Reference(ResearchConsortium) +* principalInvestigator only Reference(Practitioner) // The primary investigator +* relatedArtifact ^short = "Attribution, Study Weblinks, Citation, Study Documents, etc." +* condition ^short = "Disease or phenotypes that were interrogated during the study’s execution. MONDO, HPO " +* condition ^comment = "This is a comment" * extension contains ResearchStudyDesign named studyDesign 0..* +* extension[studyDesign] ^short = "Study Design and Study Type" + +Logical: CdeResearchStudy +Id: common-data-model-research-study +Title: "CDE Research Study" +Description: "Common Data Model representation of a research study." +* accession 1..1 SU string + "Study Accession Number" "Accession number produced by access authority such as dbGaP." +* name 1..1 SU string "Study Name" "The study's name or title" +* substudies 0..* ResearchStudy "Substudies" "A component study, often with a different type of data and/or different consent." +* description 1..1 string "The study's description" "A detailed description about the research study." +* disease_focus 0..* Coding "Disease or focus of the study" "One or more relevant disease or phenotype associated with the research study’s focus" +* attribution 0..* string "Attribution" +* weblinks 0..* string "Web Links" +* study_design 0..* Coding "Study Design" +* study_type 0..* Coding "Study Type" +* citation 0..* string "Citation(s) associated with this study" "Citations associated with this study." +* study_documents 0..* string "Study Documents" + +Mapping: NcpiResearchStudyToCdeResearchStudy +Source: NcpiResearchStudy +Target: "StructureDefinition-common-data-model-research-study.html" +Id: cde-research-study-to-ncpi-research-study +Title: "NCPI Research Study Mappings" +* identifier -> "accession" +* title -> "name" + diff --git a/input/fsh/Profile-ResearchConsortium.fsh b/input/fsh/Profile-ResearchConsortium.fsh index 9674767c..9708b344 100644 --- a/input/fsh/Profile-ResearchConsortium.fsh +++ b/input/fsh/Profile-ResearchConsortium.fsh @@ -5,4 +5,7 @@ Title: "Research Consortium" Description: "A FHIR Organization representing a single consortium of which one or more NCPI Research Studies is a member." * ^version = "0.1.0" * ^status = #draft -* name 1..1 \ No newline at end of file +* name ^short 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zqgm=Ciq4m0@UPvYR_K2{i7&K1{vS+Z^^ZTGmH)66;uDmIkNgQe;R9x=|DNPiM)~)e zz!muam?s?GY3ojz3Y&g!aQ<>Z7j1%EorBzTT>{;}4*@k*HFYJ`GfJm5EY;L>RnO?E zYAUL#>Z+>ZM3I;NG{7&w)yqBnUk{ixXK}!Q6aW1RL0*1t=pbjmoBw*uPnSpd`T=qA M+IQs_e)#df0GwScrT_o{ literal 0 HcmV?d00001 diff --git a/input/pagecontent/example-research-study-baylor-cmg.md b/input/pagecontent/example-research-study-baylor-cmg.md new file mode 100644 index 00000000..41eb7102 --- /dev/null +++ b/input/pagecontent/example-research-study-baylor-cmg.md @@ -0,0 +1,274 @@ +Research Study details can be represented in FHIR using a number of key Profiles defined within the NCPI Implementation Guide. Together, these profiles can be used to describe the properties of the study as well as relationships of the study to other studies such as through a common Consortium. These resources can also be used to indicate participant counts associated with each of the different types of access restrictions (consent, etc.) associated with components of the study. + +For this example, we have taken the [Baylor Hopkins Center for Mendelian Genomics](https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000711.v7.p2) DbGaP study and built some of the relevant resources that in compliance to the Research Study Model. + +Baylor Hopkins CMG + +# ResearchConsortium +To discuss this particular set of research studies, we must first describe the role of the consortium when discussing studies of this type. The consortium, Centers for Mendelian Genomics, is used in the NCPI FHIR Model as a mechanism for aggregating member studies together. In the diagram above, you can see that, in addition to BH-CMG, there are several other centers which would each have their own set of studies. By representing the consortium in this way, we can show their relationship to one another, by association to the Consortium. + +The profile, [ResearchConsortium](StructureDefinition-ncpi-research-consortium.html), is very simple in nature. There is a single attribute that is required specific to this IG, the name. Recommended attributes include any common Acronyms and the URL for the consortium's website. + +For this example, we have created a ResearchConsortium resource, [The Center for Mendelian Genomics](Organization-cmg-research-consortium.json.html). + +```json +{ + "resourceType" : "Organization", + "id" : "cmg-research-consortium", + "meta" : { + "profile" : [ + "https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/ncpi-research-consortium" + ] + }, + "name" : "Center for Mendelian Genomics Consortium", + "alias" : [ + "CMG" + ], + "telecom" : [ + { + "system" : "url", + "value" : "http://mendelian.org/" + } + ] +} +``` + +In this compliant example, we indicate the name of the consortium using the name attribute: +```"name": "The Center for Mendelian Genomics Consortium"``` + +Since this is commonly referred to as _CMG_, we provide that acronym as an alias: +```json +{ + "alias": [ + "CMG" + ] +} +``` + +And finally, in order to provide the consortium's website, we provide it using the _telecom_ attribute: +```json +{ + "telecom": [ + { + "system": "url", + "value": "http://mendelian.org" + } + ] +} +``` +The system, in this case, is how consumers of this data can properly interpret the value as a website URL. + +# Research Study, Baylor Hopkins, CMG +In this example, we have a dbGaP study, [BH-CMG](researchstudy-cmg-research-study-bhcmg.html), which has a number of different ways in which participants were consented. We've represented this main study as an [NCPI Research Study](StructureDefinition-ncpi-research-study.html), and will represent each of those consent components as [Research Study Subject](StructureDefinition-research-study-subject.html) resources. + +First, let's take a look at the study itself: +```json +{ + "resourceType" : "ResearchStudy", + "id" : "cmg-research-study-bhcmg", + "meta" : { + "profile" : ["https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/ncpi-research-study"] + }, + "identifier" : [{ + "system" : "http://mendelian.org/fhir", + "value" : "BH-CMG" + }, + { + "system" : "https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=", + "value" : "phs000711" + }], + "title" : "Baylor Hopkins Center for Mendelian Genomics (BH CMG)", + "status" : "completed", + "category" : [{ + "coding" : [{ + "system" : "https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/ncpi", + "code" : "StudyCohort", + "display" : "Study Cohort" + }] + }], + "focus" : [{ + "coding" : [{ + "system" : "http://purl.obolibrary.org/obo/mondo.owl", + "code" : "MONDO:0016054", + "display" : "cerebral malformation" + }] + }, + { + "coding" : [{ + "system" : "http://purl.obolibrary.org/obo/hp.owl", + "code" : "HP:0030853", + "display" : "Heterotaxy" + }, + { + "system" : "urn:oid:2.16.840.1.113883.6.177", + "code" : "D059446", + "display" : "Heterotaxy Syndrome" + }] + }, + { + "coding" : [{ + "system" : "http://purl.obolibrary.org/obo/mondo.owl", + "code" : "MONDO:0016033", + "display" : "Cornelia de Lange syndrome" + }] + }], + "relatedArtifact" : [ + { + "type" : "derived-from", + "label" : "DbGaP", + "url" : "phs000711" + }, + { + "type" : "documentation", + "label" : "Citation", + "citation" : "Gonzaga-Jauregui C, Lupski JR, Gibbs RA. Human genome sequencing in health and disease. Annu Rev Med. 2012;63:35-61. doi: 10.1146/annurev-med-051010-162644. PMID: 22248320; PMCID: PMC3656720.", + "document" : { + "url" : "https://pubmed.ncbi.nlm.nih.gov/22248320/" + } + }, + { + "type" : "documentation", + "label" : "Website", + "document" : { + "url" : "https://mendeliangenomics.org/" + } + } + ], + "description" : "The Centers for Mendelian Genomics project uses next-generation sequencing and computational approaches to discover the genes and variants that underlie Mendelian conditions. By discovering genes that cause Mendelian conditions, we will expand our understanding of their biology to facilitate diagnosis and new treatments.", + "enrollment" : [{ + "reference" : "Group/cmg-research-study-bhcmg-group" + }], + "sponsor" : { + "reference" : "Organization/cmg-research-consortium" + }, + "extension" : [{ + "url" : "https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-design", + "valueCodeableConcept" : { + "coding" : [{ + "system" : "https://dbgap-api.ncbi.nlm.nih.gov/fhir/x1/CodeSystem/ResearchStudy-StudyDesign", + "code" : "Mendelian", + "display" : "Mendelian" + }, + { + "system" : "https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/ncpi-study-types", + "code" : "Mixed", + "display" : "Mixed" + }] + } + }] +} +``` + +The first thing I'll point out is the use of identifier: +```json +{ + "identifier" : [ + { + "system" : "http://mendelian.org/fhir", + "value" : "BH-CMG" + }, + { + "system" : "https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=", + "value" : "phs000711" + } + ] +} +``` +We are providing two identifiers. One to distinguish it using the more familiar identifier, BH-CMG. Next, we are proving the dbGaP Accession ID. Both of these identifiers will be reasonable ways to refer to the study, depending on the user's relationship to the study itself. + +One of the required attributes is the title. ```"title" : "Baylor Hopkins Center for Mendelian Genomics (BH CMG)"``` We have added this requirement in order to ensure that the resource will be reasonably informative to those who are using data compliant with the NCPI FHIR IG. + +We defined the consortium to which this study belongs above. To associate this study to that consortium, we point the *sponsor* attribute to a reference to that consortium resource: + +```json +{ + "sponsor": { + "reference" : "Organization/cmg-research-consortium" + } +} +``` +This provides a way to search for research studies who are sponsored by the consortium of interest. + +Another key component is participant data. We'll define the actual study group below, but it is an important part of the Study and is, therefore, required. We've added restrictions to require enrollment to have a single StudyGroup. We've done this to enforce proper implementation of the model itself. If there are different combinations of participant enrollment, those should be captured as substudies whose "partOf" property points to this study. For this particular study's enrollment, we expect that StudyGroup to consist of the entire population associated with the study at hand. + +```json +{ + "enrollment" : [ + { + "reference" : "Group/cmg-research-study-bhcmg-group" + } + ] +} +``` + +While it isn't required, it is strongly recommended that each study resource have a complete and meaningful description that can be provided to researchers who may be interested in accessing the data from this study. For that, we use the *description* attribute: ```"description" : "The Centers for Mendelian Genomics project uses next-generation sequencing and computational approaches to discover the genes and variants that underlie Mendelian conditions. By discovering genes that cause Mendelian conditions, we will expand our understanding of their biology to facilitate diagnosis and new treatments.",``` + +In addition to details about the study itself and it's enrollment details, researches will want to be able to find information about the data that goes beyond the study itself including Citations for talks and papers that used the data, the study's website, if one exists and other types of document URLs that may be of interest to researches interested in finding out more about this study. + +For this study, we've added a few of these items using the *relatedArtifact* attribute: +```json +{ + "relatedArtifact" : [ + { + "type" : "derived-from", + "label" : "DbGaP", + "display": "phs000711", + "url" : "https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000711" + }, + { + "type" : "documentation", + "label" : "Citation", + "citation" : "Gonzaga-Jauregui C, Lupski JR, Gibbs RA. Human genome sequencing in health and disease. Annu Rev Med. 2012;63:35-61. doi: 10.1146/annurev-med-051010-162644. PMID: 22248320; PMCID: PMC3656720.", + "document" : { + "url" : "https://pubmed.ncbi.nlm.nih.gov/22248320/" + } + }, + { + "type" : "documentation", + "label" : "Website", + "document" : { + "url" : "https://mendeliangenomics.org/" + } + } + ] +} +``` +With these 3 *artifacts*, we provide the dbGaP study link and related ID, one of the citations that reference the study and the study's official website. + + + + +One of the important features for making these studies _findable_ is annotating them with proper disease codes relating the study to those diseases and phenotypes that are under study. In this case, we are only representing 3, but there is no reason to stop with any particular number. For the purpose of being concise, we'll look at one of those three diseases: + +```json +{ + "focus" : [ + { + "coding" : [{ + "system" : "http://purl.obolibrary.org/obo/hp.owl", + "code" : "HP:0030853", + "display" : "Heterotaxy" + }, + { + "system" : "urn:oid:2.16.840.1.113883.6.177", + "code" : "D059446", + "display" : "Heterotaxy Syndrome" + }] + } + ] +} +``` +For this one, we've included codings from two different ontologies: HPO and MeSH relating to Heterotaxy granting end users greater flexibility in which terms they choose for their searches. + + + +* [CMG Consortium](organization-cmg-research-consortium.html) +* [BH-CMG](researchstudy-cmg-research-study-bhcmg.html) + * [BH-CMG All Participants](group-cmg-research-study-bhcmg-group.html) + * [Consent Group HMB-NPU](researchstudy-cmg-research-study-subject-cmg-hmb-npu.html) + * [Consent HMB-NPU](consent-hmb-npu-consent.html) + * [Related StudyGroup](group-cmg-research-study-bhcmg-consent-group-hmb-npu.html) + * [Consent Group HMB-IRB-NPU](researchstudy-cmg-research-study-subject-cmg-hmb-irb-npu.html) + * [Consent HMB-IRB-NPU](consent-hmb-irb-npu-consent.html) + * [Related StudyGroup](Group-cmg-research-study-bhcmg-group-hmb-irb-npu.html) + * [Related StudyGroup](group-cmg-research-study-bhcmg-consent-group-hmb-irb-npu.html) \ No newline at end of file diff --git a/input/pagecontent/research_study.md b/input/pagecontent/research_study.md index 00676b65..0b8a8e2e 100644 --- a/input/pagecontent/research_study.md +++ b/input/pagecontent/research_study.md @@ -1,6 +1,8 @@ ### Overview This module describes the tools used for a public representation of a Research Study. The Research Study represents the umbrella under which all related information can be found. Because of its central role in data aggregation, the Research Study resource should be present, even on public servers providing only summary information. +Example NCPI Research Study Model + #### ResearchStudy The [NCPI ResearchStudy](StructureDefinition-ncpi-research-study.html) profile is used to share data about Research Studies themselves. In the NCPI setting, these resources are focused on retrieving information about the study and data from the study and not on operating a research study. Additionally, we’ve acknowledged some of the weaknesses of the R4 ResearchStudy and have included some extensions that map to the R5 version. From 8db07e5bd3740e7cb868afadf6aa1c78effd9d02 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Fri, 18 Aug 2023 16:35:19 -0500 Subject: [PATCH 39/50] Moved Examples out into their own menu --- sushi-config.yaml | 12 ++++++++++-- 1 file changed, 10 insertions(+), 2 deletions(-) diff --git a/sushi-config.yaml b/sushi-config.yaml index 38711c3d..33920842 100755 --- a/sushi-config.yaml +++ b/sushi-config.yaml @@ -53,10 +53,18 @@ menu: Childhood Cancer: childhood_cancer.html Using "Source" Data: use_case_tabular_data.html EHR Data: ehr.html - Artifacts: - All Artifacts: artifacts.html + Examples: + Research Study Examples: example-research-study-baylor-cmg.html Metadata Examples: example_study_metadata.html Raw Data Examples: example_raw_data.html + Example Resources: artifacts.html#example-example-instances + Artifacts: + All Artifacts: artifacts.html + Profiles: artifacts.html#structures-resource-profiles + Code Systems: artifacts.html#terminology-code-systems + Value Sets: artifacts.html#terminology-value-sets + Extensions: artifacts.html#structures-extension-definitions + Data Types: artifacts.html#structures-data-type-profiles Support: FHIR Versions: fhir_version.html FHIR Spec: http://hl7.org/fhir/R4/index.html From 4eabcdec20e705596ca50874058b4ed8a6ac16ff Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Fri, 18 Aug 2023 17:38:06 -0500 Subject: [PATCH 40/50] Proper header numbers to get picked up by table of content --- input/pagecontent/example-research-study-baylor-cmg.md | 4 ++-- 1 file changed, 2 insertions(+), 2 deletions(-) diff --git a/input/pagecontent/example-research-study-baylor-cmg.md b/input/pagecontent/example-research-study-baylor-cmg.md index 41eb7102..f2ab82f6 100644 --- a/input/pagecontent/example-research-study-baylor-cmg.md +++ b/input/pagecontent/example-research-study-baylor-cmg.md @@ -4,7 +4,7 @@ For this example, we have taken the [Baylor Hopkins Center for Mendelian Genomic Baylor Hopkins CMG -# ResearchConsortium +### ResearchConsortium To discuss this particular set of research studies, we must first describe the role of the consortium when discussing studies of this type. The consortium, Centers for Mendelian Genomics, is used in the NCPI FHIR Model as a mechanism for aggregating member studies together. In the diagram above, you can see that, in addition to BH-CMG, there are several other centers which would each have their own set of studies. By representing the consortium in this way, we can show their relationship to one another, by association to the Consortium. The profile, [ResearchConsortium](StructureDefinition-ncpi-research-consortium.html), is very simple in nature. There is a single attribute that is required specific to this IG, the name. Recommended attributes include any common Acronyms and the URL for the consortium's website. @@ -58,7 +58,7 @@ And finally, in order to provide the consortium's website, we provide it using t ``` The system, in this case, is how consumers of this data can properly interpret the value as a website URL. -# Research Study, Baylor Hopkins, CMG +### Research Study, Baylor Hopkins, CMG In this example, we have a dbGaP study, [BH-CMG](researchstudy-cmg-research-study-bhcmg.html), which has a number of different ways in which participants were consented. We've represented this main study as an [NCPI Research Study](StructureDefinition-ncpi-research-study.html), and will represent each of those consent components as [Research Study Subject](StructureDefinition-research-study-subject.html) resources. First, let's take a look at the study itself: From 920873dd0841fd7002fc46fc4b3cde19a3370e77 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 21 Aug 2023 16:19:33 -0500 Subject: [PATCH 41/50] Added details about the logical Common Data Model Study --- input/fsh/Profile-NCPI-ResearchStudy.fsh | 1 + ...-common-data-model-research-study-intro.md | 4 ++++ ...-common-data-model-research-study-notes.md | 23 +++++++++++++++++++ 3 files changed, 28 insertions(+) create mode 100644 input/pagecontent/StructureDefinition-common-data-model-research-study-intro.md create mode 100644 input/pagecontent/StructureDefinition-common-data-model-research-study-notes.md diff --git a/input/fsh/Profile-NCPI-ResearchStudy.fsh b/input/fsh/Profile-NCPI-ResearchStudy.fsh index bc62743e..251450c2 100644 --- a/input/fsh/Profile-NCPI-ResearchStudy.fsh +++ b/input/fsh/Profile-NCPI-ResearchStudy.fsh @@ -44,6 +44,7 @@ Logical: CdeResearchStudy Id: common-data-model-research-study Title: "CDE Research Study" Description: "Common Data Model representation of a research study." +* consortium 0..1 SU string "Consortium" "Parent organization to which the study is a member." * accession 1..1 SU string "Study Accession Number" "Accession number produced by access authority such as dbGaP." * name 1..1 SU string "Study Name" "The study's name or title" diff --git a/input/pagecontent/StructureDefinition-common-data-model-research-study-intro.md b/input/pagecontent/StructureDefinition-common-data-model-research-study-intro.md new file mode 100644 index 00000000..a71ffb08 --- /dev/null +++ b/input/pagecontent/StructureDefinition-common-data-model-research-study-intro.md @@ -0,0 +1,4 @@ +With regard to this Implementation Guide, a research study is an organized collection of data used by researchers to further the understanding of human health, genetics, drug response, etc. A single study can be comprised of multiple smaller sub-studies or be a single unit. The study will likely be hosted in a public database such as dbGaP and will be associated with citations in scientific journals. The study itself may be a part of a large organization of researcher studies, such as a consortium. + +To discuss the way in which a *Research Study* is represented in FHIR, we must first establish what it is that is being discussed. To do this, we have created a "Common Data Model" that represents the study at a high level and represent it using FHIR's logical model. + diff --git a/input/pagecontent/StructureDefinition-common-data-model-research-study-notes.md b/input/pagecontent/StructureDefinition-common-data-model-research-study-notes.md new file mode 100644 index 00000000..f32c3c7a --- /dev/null +++ b/input/pagecontent/StructureDefinition-common-data-model-research-study-notes.md @@ -0,0 +1,23 @@ +### Identifiers (Accession IDs, Acronyms, etc) +For those studies where the data has been submitted to a public database such as dbGaP, there will be a formal identifier such as an Accession Number assigned to it. This is identifier will be important for other researchers to easily identify exactly which study is being described. + +Other ids too are important, such as those IDs that are used to differentiate the study from it's consortium peer studies. + +For the purposes of this *model*, we'll refer to all of these as *accession* ids. + +### Name and description +Each study will have a name as well as a detailed description. + +### Attribution, Weblinks, citation and study documents + +### Study Design and Study Type + +### Study Focus +Studies will have one or more focus which may be either a disease or a phenotype. + +### Studies may be comprised of substudies +These sub-studies may be related to data-use restrictions such as how participants were consented or the types of data that were captured for study. + +### Organizational Membership +A study may be a member of an organization, such as a consortium. + From e7a8741fe6e2abd63c2a4c80ca8f9a0a90c3bc59 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 21 Aug 2023 16:20:24 -0500 Subject: [PATCH 42/50] Added displays to the terms for clarity --- input/fsh/Example-CMG-ResearchStudy.fsh | 10 +++++----- 1 file changed, 5 insertions(+), 5 deletions(-) diff --git a/input/fsh/Example-CMG-ResearchStudy.fsh b/input/fsh/Example-CMG-ResearchStudy.fsh index d6e9db39..f034fdfd 100644 --- a/input/fsh/Example-CMG-ResearchStudy.fsh +++ b/input/fsh/Example-CMG-ResearchStudy.fsh @@ -84,8 +84,8 @@ Description: "Consented with Health/Medical/Biomedical + Not for profit use" * scope = #research * category.coding = http://terminology.hl7.org/CodeSystem/consentcategorycodes#research * provision.type = http://hl7.org/fhir/consent-provision-type#permit -* provision.purpose[+] = $nihcc#HMB -* provision.purpose[+] = $nihcc#NPU +* provision.purpose[+] = $nihcc#HMB "Health/Medical/Biomedical" +* provision.purpose[+] = $nihcc#NPU "Not-for-profit use only" //* category.text = "HMB-NPU" Instance: cmg-research-study-subject-cmg-hmb-npu @@ -124,9 +124,9 @@ Description: "Consented with Health/Medical/Biomedical + IRB Required + Not for * scope = #research * category.coding = http://terminology.hl7.org/CodeSystem/consentcategorycodes#research * provision.type = http://hl7.org/fhir/consent-provision-type#permit -* provision.purpose[+] = $nihcc#HMB -* provision.purpose[+] = $nihcc#IRB -* provision.purpose[+] = $nihcc#NPU +* provision.purpose[+] = $nihcc#HMB "Health/Medical/Biomedical" +* provision.purpose[+] = $nihcc#IRB "IRB approval required" +* provision.purpose[+] = $nihcc#NPU "Not-for-profit use only" //* category.text = "HMB-IRB-NPU" Instance: cmg-research-study-subject-cmg-hmb-irb-npu From 44d895e5bc1c2b121895dc857c53d56012fe1e9b Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 21 Aug 2023 16:21:02 -0500 Subject: [PATCH 43/50] Additional content --- .../example-research-study-baylor-cmg.md | 34 ++++++++++++++++++- 1 file changed, 33 insertions(+), 1 deletion(-) diff --git a/input/pagecontent/example-research-study-baylor-cmg.md b/input/pagecontent/example-research-study-baylor-cmg.md index f2ab82f6..731b4681 100644 --- a/input/pagecontent/example-research-study-baylor-cmg.md +++ b/input/pagecontent/example-research-study-baylor-cmg.md @@ -58,7 +58,7 @@ And finally, in order to provide the consortium's website, we provide it using t ``` The system, in this case, is how consumers of this data can properly interpret the value as a website URL. -### Research Study, Baylor Hopkins, CMG +### NCPI Research Study, Baylor Hopkins, CMG In this example, we have a dbGaP study, [BH-CMG](researchstudy-cmg-research-study-bhcmg.html), which has a number of different ways in which participants were consented. We've represented this main study as an [NCPI Research Study](StructureDefinition-ncpi-research-study.html), and will represent each of those consent components as [Research Study Subject](StructureDefinition-research-study-subject.html) resources. First, let's take a look at the study itself: @@ -260,7 +260,39 @@ One of the important features for making these studies _findable_ is annotating ``` For this one, we've included codings from two different ontologies: HPO and MeSH relating to Heterotaxy granting end users greater flexibility in which terms they choose for their searches. +#### Access Control (Consent Groups, etc) +Where different aspects of a study are broken into distinct groupings of participants based on study focus (Whole Genome data versus panel datasets) or Consent, we want to capture those key groups in FHIR. To do so, we are modelling the main component of this top level R4 resource, the ResearchStudySubject, after the R5 version of FHIR's ResearchSubject resource. This allows us to tie a single Consent resource to the group and to associate it with the parent ResearchStudy using the *partOf* attribute. +For the purposes of this example, we've represented two of the consent groups listed in dbGaP for BM-CMG, HMB-NPU and HMB-IRB-NPU. + +##### Research Study Subject, BH-CMG HMB, NPU +As stated above, the chief goal of the ResearchStudySubject is to associate a portion of Participants whose data is restricted in identical ways. In this case, by the restrictions, *Health/Medical/Biomedical* Research and *Not-for-profit use only*. + +There is a list of participants consented in this way that have been identified in the corresponding [StudyGroup](group-cmg-research-study-bhcmg-consent-group-hmb-npu.html). As well as the actual [Consent](consent-hmb-npu-consent.html) itself. + +###### Research Study Consent, BH-CMG HMB-NPU +The main purpose of the ResearchStudyConsent is to capture the individual components of the access restrictions and this is done using the provision.purpose attribute: + +```json +{ + "provision" : { + "type" : "permit", + "purpose" : [ + { + "system" : "https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/nih-consent", + "code" : "HMB", + "display" : "Health/Medical/Biomedical" + }, + { + "system" : "https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/nih-consent", + "code" : "NPU", + "display" : "Not-for-profit use only" + } + ] + } +} +``` +The provision property's attribute, purpose, accepts one or more codings, each of which describes an aspect of the particular consent's restrictions. In this case, we use two codes from the NIH Consent CodeSystem, HMB and NPU. * [CMG Consortium](organization-cmg-research-consortium.html) * [BH-CMG](researchstudy-cmg-research-study-bhcmg.html) From 7fb783a91e52c32022bb2449bdc2ec817d9178c4 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Wed, 23 Aug 2023 12:46:14 -0500 Subject: [PATCH 44/50] First pass at general example overview of research study --- .../example-research-study-baylor-cmg.md | 159 +++++++++++++++++- 1 file changed, 151 insertions(+), 8 deletions(-) diff --git a/input/pagecontent/example-research-study-baylor-cmg.md b/input/pagecontent/example-research-study-baylor-cmg.md index 731b4681..8bf34a6c 100644 --- a/input/pagecontent/example-research-study-baylor-cmg.md +++ b/input/pagecontent/example-research-study-baylor-cmg.md @@ -260,19 +260,69 @@ One of the important features for making these studies _findable_ is annotating ``` For this one, we've included codings from two different ontologies: HPO and MeSH relating to Heterotaxy granting end users greater flexibility in which terms they choose for their searches. -#### Access Control (Consent Groups, etc) -Where different aspects of a study are broken into distinct groupings of participants based on study focus (Whole Genome data versus panel datasets) or Consent, we want to capture those key groups in FHIR. To do so, we are modelling the main component of this top level R4 resource, the ResearchStudySubject, after the R5 version of FHIR's ResearchSubject resource. This allows us to tie a single Consent resource to the group and to associate it with the parent ResearchStudy using the *partOf* attribute. +Before getting into the individual sub-studies which represent the different types of consent participants agreed to, we should discuss a few related resources. -For the purposes of this example, we've represented two of the consent groups listed in dbGaP for BM-CMG, HMB-NPU and HMB-IRB-NPU. +### Access Control - ResearchStudyConsent +For the purposes of this implementation guide, when we talk about access control, we are not discussing restricting access to data within FHIR, but about the limitations associated with the research data itself as is defined by the study's principal investigators. There are expected to be appropriate controls in place to restrict access to the data according to those restrictions, but that is not up to the IG to determine how that happens. -##### Research Study Subject, BH-CMG HMB, NPU -As stated above, the chief goal of the ResearchStudySubject is to associate a portion of Participants whose data is restricted in identical ways. In this case, by the restrictions, *Health/Medical/Biomedical* Research and *Not-for-profit use only*. +What we can discuss is what those restrictions are so that FHIR resource consumers can identify whether the data being described can be used in their research. Once a researcher identifies the data that meets their needs, it is beyond the scope of this IG to determine how they go about getting access to that data. -There is a list of participants consented in this way that have been identified in the corresponding [StudyGroup](group-cmg-research-study-bhcmg-consent-group-hmb-npu.html). As well as the actual [Consent](consent-hmb-npu-consent.html) itself. +While there are likely many ways to describe access control, one of the more common mechanisms used in research is that of consent and a common approach is to aggregate participants together according to the consent they agreed upon. In FHIR, we represent this consent using the profile, [Research Study Consent](StructureDefinition-research-study-consent.html). Our BM-CMG example contains two different consent resources: [HMB-NPU](Consent-hmb-npu-consent.html) and [HMB-IRB-NPU](Consent-hmb-irb-npu-consent.html). -###### Research Study Consent, BH-CMG HMB-NPU -The main purpose of the ResearchStudyConsent is to capture the individual components of the access restrictions and this is done using the provision.purpose attribute: +Because they are very similar, we'll look at one of them in detail. It is important to note that a study may consent participants differently as the study progresses and that each of those different consent configurations should be represented in FHIR. +```json +{ + "resourceType" : "Consent", + "id" : "hmb-irb-npu-consent", + "meta" : { + "profile" : [ + "https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-consent" + ] + }, + "status" : "draft", + "scope" : { + "coding" : [ + { + "code" : "research" + } + ] + }, + "category" : [ + { + "coding" : [ + { + "system" : "http://terminology.hl7.org/CodeSystem/consentcategorycodes", + "code" : "research", + "display" : "Research Information Access" + } + ] + } + ], + "provision" : { + "type" : "permit", + "purpose" : [ + { + "system" : "https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/nih-consent", + "code" : "HMB", + "display" : "Health/Medical/Biomedical" + }, + { + "system" : "https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/nih-consent", + "code" : "IRB", + "display" : "IRB approval required" + }, + { + "system" : "https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/nih-consent", + "code" : "NPU", + "display" : "Not-for-profit use only" + } + ] + } +} +``` + +The most important thing to note with this resource is that of the provision: ```json { "provision" : { @@ -283,6 +333,11 @@ The main purpose of the ResearchStudyConsent is to capture the individual compon "code" : "HMB", "display" : "Health/Medical/Biomedical" }, + { + "system" : "https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/nih-consent", + "code" : "IRB", + "display" : "IRB approval required" + }, { "system" : "https://nih-ncpi.github.io/ncpi-fhir-ig/CodeSystem/nih-consent", "code" : "NPU", @@ -292,6 +347,94 @@ The main purpose of the ResearchStudyConsent is to capture the individual compon } } ``` +Each of those member codes represent a different facet of the consent which, together, represents the complete set of restrictions put into place for researchers intending on using the data for their own research. In this case, researchers can only use this data for health, medical or biomedical research at a non-profit organization after approval by the IRB panel. + +### Participant Groups - StudyGroup +In FHIR, we use the [StudyGroup](StructureDefinition-study-group.html) profile to establish the population under study. At the top-most level, the StudyGroup would point to the entire population of the research study. For sub-studies such as consent groups, the StudyGroup reflects only the relevant members of that grouping. + +The groups provide two main pieces of information: +* Group Population +* Group Size + +The Population itself is only relevant if there is a desire to link the group to the actual participants, such as when the server is hosting Study details as well as patient level data. However, if the purpose of the FHIR server is only to provide information about the studies for the purposes of findability, the population itself is no required to be enumerated. Patients will be enumerated using the member attribute in when linking to the patient data is relevant. + +Group size, on the other hand, is a must. This detail makes it possible to summarize the contents of a study without having access to the row level data. For the purposes of these examples, we'll only provide the group size. + +#### StudyGroup - Examples +For this particular example, we have 3 different StudyGroups that we need to define. One for the entire study population and 1 for each of the two Consents that we have chosen to represent. These are very similar, so we'll only cover one of the three, but users should feel free to look at each of them: [BM-CMG Study Partipants](Group-cmg-research-study-bhcmg-group.html), [BM-CMG Consented by HMB-NPU](Group-cmg-research-study-bhcmg-consent-group-hmb-npu.html) and [BH-CMG Consented by HMB-IRB-NPU](Group-cmg-research-study-bhcmg-consent-group-hmb-irb-npu.html). + +Let's take a look at the HMB-IRB StudyGroup: +```json +{ + "resourceType" : "Group", + "id" : "cmg-research-study-bhcmg-consent-group-hmb-irb-npu", + "meta" : { + "profile" : [ + "https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/study-group" + ] + }, + "type" : "person", + "actual" : true, + "name" : "BM-CMG Study HMB-IRB-NPU Participants", + "quantity" : 780 +} +``` +As you can see, there isn't too much there because this example isn't intended to refer to patient level data. As such, we opted to leave the member attribute out of the resource. + +The first and most important thing to note is the quantity: ```"quantity": 780```. As mentioned above, this is vital for summary purposes since the actual membership isn't required. We also require the use of ```"actual": true``` which indicates that the group is describing a specific set of participants as opposed to being a descriptive set of characteristics. The profile also requires that the group's type be that of *person* since our current focus is on Human Research. We indicate this using the type as follows: ```"type": "person"```. + +While it isn't required, we strongly recommend using meaningful names to help clarify to the consumer what the group is for when seen outside the context of other, related resources. In this case, we see the following: ```"name": "BM-CMG Study HMB-IRB-NPU Participants"``` + + + +### Research Study Subject +While there may be many reasons to tie a subset of the study's entire population to a *sub-study*, such as called whole genomes on a sub-population due to budget, the focus of this profile is to distinguish the members of a common set of data restrictions. Often, this is referred to as the Consent group since the group of participants are consented with the same set of data restrictions. To represent these groups in FHIR, we are modelling the main component of this top level R4 resource, the [ResearchStudySubject](StructureDefinition-research-study-subject.html), after the R5 version of FHIR's ResearchSubject resource. This allows us to tie a single Consent resource to the group and to associate it with the parent ResearchStudy using the *partOf* attribute. + +For the purposes of this example, we've represented two of the consent groups listed in dbGaP for BM-CMG, [HMB-NPU](ResearchStudy-cmg-research-study-subject-cmg-hmb-npu.html) and [HMB-IRB-NPU](ResearchStudy-cmg-research-study-subject-cmg-hmb-irb-npu.html). These two resources are very similar, so we'll only discuss one of them in detail. + +#### Research Study Subject, BH-CMG HMB-IRB-NPU +As stated above, the chief goal of the ResearchStudySubject is to associate a portion of Participants whose data is restricted in identical ways. In this case, by the restrictions, *Health/Medical/Biomedical* Research, "IRB approval required" and *Not-for-profit use only*. These restrictions specify the limits any researcher is bound to when using the data consented in this way. + +```json +{ + "resourceType" : "ResearchStudy", + "id" : "cmg-research-study-subject-cmg-hmb-irb-npu", + "meta" : { + "profile" : [ + "https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-subject" + ] + }, + "extension" : [ + { + "url" : "https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-subject-consent", + "valueReference" : { + "reference" : "Consent/hmb-irb-npu-consent" + } + } + ], + "identifier" : [ + { + "system" : "http://mendelian.org/fhir", + "value" : "BH-CMG-HMB-IRB-NPU" + } + ], + "title" : "BH-CMG HMB-IRB-NPU Consent Study Subject", + "partOf" : [ + { + "reference" : "ResearchStudy/cmg-research-study-bhcmg" + } + ], + "status" : "completed", + "enrollment" : [ + { + "reference" : "cmg-research-study-bhcmg-group-hmb-irb-npu" + } + ] +} +``` + + + The provision property's attribute, purpose, accepts one or more codings, each of which describes an aspect of the particular consent's restrictions. In this case, we use two codes from the NIH Consent CodeSystem, HMB and NPU. * [CMG Consortium](organization-cmg-research-consortium.html) From 810b04baa99cce43290ca409a101917d3000bd82 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Wed, 23 Aug 2023 14:00:58 -0500 Subject: [PATCH 45/50] First pass at general example overview of research study --- input/fsh/Example-CMG-ResearchStudy.fsh | 3 +++ .../example-research-study-baylor-cmg.md | 20 +++++++++++++++---- 2 files changed, 19 insertions(+), 4 deletions(-) diff --git a/input/fsh/Example-CMG-ResearchStudy.fsh b/input/fsh/Example-CMG-ResearchStudy.fsh index f034fdfd..144534b5 100644 --- a/input/fsh/Example-CMG-ResearchStudy.fsh +++ b/input/fsh/Example-CMG-ResearchStudy.fsh @@ -110,6 +110,9 @@ InstanceOf: StudyGroup Title: "Participants consented under HMB-NPU" Usage: #example Description: "BH-CMG study's population consented under Health/Medical/Biomedical + Not for profit use" +* identifier[0] + * system = "http://mendelian.org/fhir/Group" + * value = "HMB-NPU-Participants" * name = "BM-CMG Study HMB-NPU Participants" * quantity = 1665 * actual = true diff --git a/input/pagecontent/example-research-study-baylor-cmg.md b/input/pagecontent/example-research-study-baylor-cmg.md index 8bf34a6c..5a0d2bd3 100644 --- a/input/pagecontent/example-research-study-baylor-cmg.md +++ b/input/pagecontent/example-research-study-baylor-cmg.md @@ -5,7 +5,7 @@ For this example, we have taken the [Baylor Hopkins Center for Mendelian Genomic Baylor Hopkins CMG ### ResearchConsortium -To discuss this particular set of research studies, we must first describe the role of the consortium when discussing studies of this type. The consortium, Centers for Mendelian Genomics, is used in the NCPI FHIR Model as a mechanism for aggregating member studies together. In the diagram above, you can see that, in addition to BH-CMG, there are several other centers which would each have their own set of studies. By representing the consortium in this way, we can show their relationship to one another, by association to the Consortium. +To discuss this particular set of research studies, we must first describe the role of the consortium when discussing studies of this type. The consortium, Centers for Mendelian Genomics, is used in the NCPI FHIR Model as a mechanism for aggregating member studies together. In the diagram above, you can see that, in addition to BH-CMG, there are several other centers which would each have their own set of studies. By representing the consortium in this way, we can show their relationship to one another by association to the Consortium. The profile, [ResearchConsortium](StructureDefinition-ncpi-research-consortium.html), is very simple in nature. There is a single attribute that is required specific to this IG, the name. Recommended attributes include any common Acronyms and the URL for the consortium's website. @@ -59,7 +59,7 @@ And finally, in order to provide the consortium's website, we provide it using t The system, in this case, is how consumers of this data can properly interpret the value as a website URL. ### NCPI Research Study, Baylor Hopkins, CMG -In this example, we have a dbGaP study, [BH-CMG](researchstudy-cmg-research-study-bhcmg.html), which has a number of different ways in which participants were consented. We've represented this main study as an [NCPI Research Study](StructureDefinition-ncpi-research-study.html), and will represent each of those consent components as [Research Study Subject](StructureDefinition-research-study-subject.html) resources. +In this example, we have a dbGaP study, [BH-CMG](researchstudy-cmg-research-study-bhcmg.html), which has two ways in which participants were consented. We've represented this main study as an [NCPI Research Study](StructureDefinition-ncpi-research-study.html) and will represent each of those consent components as [Research Study Subject](StructureDefinition-research-study-subject.html) resources. First, let's take a look at the study itself: ```json @@ -187,9 +187,9 @@ We defined the consortium to which this study belongs above. To associate this s } } ``` -This provides a way to search for research studies who are sponsored by the consortium of interest. +This provides a way to search for research studies who are sponsored by the consortium of interest. Perhaps even more importantly, this reference is actually a valid path to the entity being referred to. In this case, it's a local reference to the Organization, *CMG Research Consortium* and is a valid Path to that specific resource. -Another key component is participant data. We'll define the actual study group below, but it is an important part of the Study and is, therefore, required. We've added restrictions to require enrollment to have a single StudyGroup. We've done this to enforce proper implementation of the model itself. If there are different combinations of participant enrollment, those should be captured as substudies whose "partOf" property points to this study. For this particular study's enrollment, we expect that StudyGroup to consist of the entire population associated with the study at hand. +Another key component is participant data. We'll define the actual study group below, but it is an important part of the Study and is, therefore, required. We've added restrictions to require enrollment to have a single StudyGroup. We've done this to enforce proper implementation of the model itself. If there are different combinations of participant enrollment, those should be captured as substudies whose "partOf" property points to this study. For this particular study's enrollment, we expect that particular StudyGroup to consist of the entire population associated with the study at hand. ```json { @@ -200,6 +200,7 @@ Another key component is participant data. We'll define the actual study group b ] } ``` +As stated above, this reference should be a valid path to the relevant resource. While it isn't required, it is strongly recommended that each study resource have a complete and meaningful description that can be provided to researchers who may be interested in accessing the data from this study. For that, we use the *description* attribute: ```"description" : "The Centers for Mendelian Genomics project uses next-generation sequencing and computational approaches to discover the genes and variants that underlie Mendelian conditions. By discovering genes that cause Mendelian conditions, we will expand our understanding of their biology to facilitate diagnosis and new treatments.",``` @@ -433,6 +434,17 @@ As stated above, the chief goal of the ResearchStudySubject is to associate a po } ``` +The first thing to note is the reference to the appropriate StudyGroup in the enrollment attribute: +```json +{ + "enrollment" : [ + { + "reference" : "cmg-research-study-bhcmg-group-hmb-irb-npu" + } + ] +} +``` + The provision property's attribute, purpose, accepts one or more codings, each of which describes an aspect of the particular consent's restrictions. In this case, we use two codes from the NIH Consent CodeSystem, HMB and NPU. From 456f225b1c8de5d092f42615ecc66531ce141a4a Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Wed, 23 Aug 2023 16:06:18 -0500 Subject: [PATCH 46/50] Additional refinements --- input/fsh/Example-CMG-ResearchStudy.fsh | 3 ++ input/fsh/Profile-NCPI-ResearchStudy.fsh | 13 ++----- ...-common-data-model-research-study-intro.md | 4 +-- ...-common-data-model-research-study-notes.md | 7 ++-- .../example-research-study-baylor-cmg.md | 35 ++++++++++++++++--- 5 files changed, 41 insertions(+), 21 deletions(-) diff --git a/input/fsh/Example-CMG-ResearchStudy.fsh b/input/fsh/Example-CMG-ResearchStudy.fsh index 144534b5..e9105149 100644 --- a/input/fsh/Example-CMG-ResearchStudy.fsh +++ b/input/fsh/Example-CMG-ResearchStudy.fsh @@ -151,6 +151,9 @@ InstanceOf: StudyGroup Title: "Participants consented under HMB-IRB-NPU" Usage: #example Description: "BH-CMG study's population consented under Health/Medical/Biomedical + IRB Approval Required + Not for profit use" +* identifier[0] + * system = "http://mendelian.org/fhir/Group" + * value = "HMB-IRB-NPU-Participants" * name = "BM-CMG Study HMB-IRB-NPU Participants" * quantity = 780 * actual = true diff --git a/input/fsh/Profile-NCPI-ResearchStudy.fsh b/input/fsh/Profile-NCPI-ResearchStudy.fsh index 251450c2..1d6c21b4 100644 --- a/input/fsh/Profile-NCPI-ResearchStudy.fsh +++ b/input/fsh/Profile-NCPI-ResearchStudy.fsh @@ -40,10 +40,10 @@ Description: "The NCPI Research Study is based upon the core HL7 FHIR ResearchSt * extension contains ResearchStudyDesign named studyDesign 0..* * extension[studyDesign] ^short = "Study Design and Study Type" -Logical: CdeResearchStudy +Logical: CdmResearchStudy Id: common-data-model-research-study -Title: "CDE Research Study" -Description: "Common Data Model representation of a research study." +Title: "CDM Research Study" +Description: "The *CDM Research Study* is a logical model intended to represent the real world concept of a scientific research study to be used when describing NCPI Profiles and how their attributes are mapped to actual study properties." * consortium 0..1 SU string "Consortium" "Parent organization to which the study is a member." * accession 1..1 SU string "Study Accession Number" "Accession number produced by access authority such as dbGaP." @@ -58,11 +58,4 @@ Description: "Common Data Model representation of a research study." * citation 0..* string "Citation(s) associated with this study" "Citations associated with this study." * study_documents 0..* string "Study Documents" -Mapping: NcpiResearchStudyToCdeResearchStudy -Source: NcpiResearchStudy -Target: "StructureDefinition-common-data-model-research-study.html" -Id: cde-research-study-to-ncpi-research-study -Title: "NCPI Research Study Mappings" -* identifier -> "accession" -* title -> "name" diff --git a/input/pagecontent/StructureDefinition-common-data-model-research-study-intro.md b/input/pagecontent/StructureDefinition-common-data-model-research-study-intro.md index a71ffb08..87c8ccda 100644 --- a/input/pagecontent/StructureDefinition-common-data-model-research-study-intro.md +++ b/input/pagecontent/StructureDefinition-common-data-model-research-study-intro.md @@ -1,4 +1,2 @@ -With regard to this Implementation Guide, a research study is an organized collection of data used by researchers to further the understanding of human health, genetics, drug response, etc. A single study can be comprised of multiple smaller sub-studies or be a single unit. The study will likely be hosted in a public database such as dbGaP and will be associated with citations in scientific journals. The study itself may be a part of a large organization of researcher studies, such as a consortium. - -To discuss the way in which a *Research Study* is represented in FHIR, we must first establish what it is that is being discussed. To do this, we have created a "Common Data Model" that represents the study at a high level and represent it using FHIR's logical model. +With regard to this Implementation Guide, a research study is a collection of data gathered through a systematic investigation aimed at acquiring insights into healthcare-related topics. A research study can encompass a standalone unit or consists of sub-studies often hosted in public databases, such as dbGaP. The study, or studies, may or may not be integrated into a broader consortia of research studies and is composed of the following elements described [below](StructureDefinition-common-data-model-research-study.html#notes). diff --git a/input/pagecontent/StructureDefinition-common-data-model-research-study-notes.md b/input/pagecontent/StructureDefinition-common-data-model-research-study-notes.md index f32c3c7a..c6f94df6 100644 --- a/input/pagecontent/StructureDefinition-common-data-model-research-study-notes.md +++ b/input/pagecontent/StructureDefinition-common-data-model-research-study-notes.md @@ -1,7 +1,8 @@ ### Identifiers (Accession IDs, Acronyms, etc) -For those studies where the data has been submitted to a public database such as dbGaP, there will be a formal identifier such as an Accession Number assigned to it. This is identifier will be important for other researchers to easily identify exactly which study is being described. - -Other ids too are important, such as those IDs that are used to differentiate the study from it's consortium peer studies. +Identifiers serve to allow researchers to identify exactly which study is being described. This includes Accession Numbers for studies where the data has been submitted to a public database such as dbGaP. Other identifiers may include IDs that differentiate the study from consortium peer studies and … +The identifiers may include: +* dbGaP +* Acronyms For the purposes of this *model*, we'll refer to all of these as *accession* ids. diff --git a/input/pagecontent/example-research-study-baylor-cmg.md b/input/pagecontent/example-research-study-baylor-cmg.md index 5a0d2bd3..e4f03f13 100644 --- a/input/pagecontent/example-research-study-baylor-cmg.md +++ b/input/pagecontent/example-research-study-baylor-cmg.md @@ -428,26 +428,51 @@ As stated above, the chief goal of the ResearchStudySubject is to associate a po "status" : "completed", "enrollment" : [ { - "reference" : "cmg-research-study-bhcmg-group-hmb-irb-npu" + "reference" : "Group/cmg-research-study-bhcmg-consent-group-hmb-irb-npu" } ] } ``` -The first thing to note is the reference to the appropriate StudyGroup in the enrollment attribute: +The first thing to note is the reference to the parent study by way of the *partOf* attribute: ```json { - "enrollment" : [ + "partOf" : [ { - "reference" : "cmg-research-study-bhcmg-group-hmb-irb-npu" + "reference" : "ResearchStudy/cmg-research-study-bhcmg" } ] } ``` +This ties the other StudyGroup associated with this portion of the study back to the parent study. +Next notice the reference to the appropriate StudyGroup in the enrollment attribute: +```json +{ + "enrollment" : [ + { + "reference" : "Group/cmg-research-study-bhcmg-consent-group-hmb-irb-npu" + } + ] +} +``` +This links the ResearchStudySubject to the StudyGroup which describes the participants consented under the HMB, IRB and NPU consent. +Finally, we link the link to the actual consent resource using the extension, [research-study-subject-consent](structuredefinition-research-study-subject-consent.html). +```json +{ + "extension" : [ + { + "url" : "https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-study-subject-consent", + "valueReference" : { + "reference" : "Consent/hmb-irb-npu-consent" + } + } + ] +} +``` +This is a feature of the R5 version of ResearchStudy that allows us to match all members of the one StudyGroup to a single consent. -The provision property's attribute, purpose, accepts one or more codings, each of which describes an aspect of the particular consent's restrictions. In this case, we use two codes from the NIH Consent CodeSystem, HMB and NPU. * [CMG Consortium](organization-cmg-research-consortium.html) * [BH-CMG](researchstudy-cmg-research-study-bhcmg.html) From 503021fb8089f912af716b5c5771984b426a8552 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Thu, 26 Oct 2023 16:42:51 -0500 Subject: [PATCH 47/50] Trying v4.3.0 to see if it will enable validation on HAPI 4.3 --- sushi-config.yaml | 4 ++-- 1 file changed, 2 insertions(+), 2 deletions(-) diff --git a/sushi-config.yaml b/sushi-config.yaml index 33920842..66104ab0 100755 --- a/sushi-config.yaml +++ b/sushi-config.yaml @@ -10,8 +10,8 @@ description: "FHIR Implementation Guide for the NIH Cloud Platform Interoperabil status: draft license: CC0-1.0 version: 0.2.0 -fhirVersion: 4.0.1 -#fhirVersion: 4.3.0 +#fhirVersion: 4.0.1 +fhirVersion: 4.3.0 copyrightYear: 2021+ releaseLabel: ci-build publisher: From 192855441a1955f69d609f29888934b9f5825856 Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 4 Mar 2024 16:31:56 -0600 Subject: [PATCH 48/50] Adding an extra 'column' to verify our Phenotype profile works as desired --- input/fsh/Example-Dataset-DataDictionary.fsh | 1 + 1 file changed, 1 insertion(+) diff --git a/input/fsh/Example-Dataset-DataDictionary.fsh b/input/fsh/Example-Dataset-DataDictionary.fsh index 126c1608..0f871684 100644 --- a/input/fsh/Example-Dataset-DataDictionary.fsh +++ b/input/fsh/Example-Dataset-DataDictionary.fsh @@ -37,6 +37,7 @@ Description: "Example CodeSystem for a data-dictionary table with 4 variables re * #age_at_enrollment "Subject's Age at Enrollment in days" * #bmi "Subject's BMI, Measured at Enrollment" * #status "Subject's status (Case or Control)" +* #phenotype "An example phenotype observed for study" ValueSet: ExampleStudyDataDictionaryCaseControlVS1 Id: example-study-data-dictionary-case-control-vs-1 From 80c26e47014aa207aaaaf888f1c2c93e79f1918a Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 4 Mar 2024 16:33:34 -0600 Subject: [PATCH 49/50] Sliced Phenotypes to permit other codes in addition to those supported by the ValueSet, phenotype codes --- input/fsh/Instance-Phenotype.fsh | 3 ++- input/fsh/Profile-Phenotype.fsh | 9 ++++++++- 2 files changed, 10 insertions(+), 2 deletions(-) diff --git a/input/fsh/Instance-Phenotype.fsh b/input/fsh/Instance-Phenotype.fsh index 4331a1d1..c1def8cf 100755 --- a/input/fsh/Instance-Phenotype.fsh +++ b/input/fsh/Instance-Phenotype.fsh @@ -7,7 +7,8 @@ InstanceOf: Phenotype Usage: #example Description: "Example of the representation of observed Phenotype." * verificationStatus = $condition-ver-status#confirmed "Confirmed" -* code = $hpo#HP:0000076 "Vesicoureteral reflux" +* code.coding[+] = $hpo#HP:0000076 "Vesicoureteral reflux" +* code.coding[+] = $ExampleStudyTableCS#phenotype * code.text = "Present: Vesicoureteral reflux" * subject = Reference(patient-example-1) * recordedDate.extension.url = $cqf-relativeDateTime diff --git a/input/fsh/Profile-Phenotype.fsh b/input/fsh/Profile-Phenotype.fsh index a56c057f..ca80704e 100755 --- a/input/fsh/Profile-Phenotype.fsh +++ b/input/fsh/Profile-Phenotype.fsh @@ -5,4 +5,11 @@ Title: "NCPI Phenotype" Description: "Representation of phenotypic observations (present or absent)" * ^version = "0.1.0" * ^status = #draft -* code from phenotype-codes (required) +* code.coding ^slicing.discriminator.type = #pattern +* code.coding ^slicing.discriminator.path = "code" +* code.coding ^slicing.rules = #openAtEnd +* code.coding ^slicing.ordered = true +* code.coding ^slicing.description = "Slice to require at least the one code from the phenotype-code value-set" +* code.coding contains + pheno-code 1..* +* code.coding[pheno-code].code from phenotype-codes (required) From 6091cad33f661df7b8384ed2e97eafae53c403ae Mon Sep 17 00:00:00 2001 From: Eric Torstenson Date: Mon, 4 Mar 2024 16:34:00 -0600 Subject: [PATCH 50/50] 'Officially' switched to 4.3.0B --- sushi-config.yaml | 4 ++-- 1 file changed, 2 insertions(+), 2 deletions(-) diff --git a/sushi-config.yaml b/sushi-config.yaml index 33920842..66104ab0 100755 --- a/sushi-config.yaml +++ b/sushi-config.yaml @@ -10,8 +10,8 @@ description: "FHIR Implementation Guide for the NIH Cloud Platform Interoperabil status: draft license: CC0-1.0 version: 0.2.0 -fhirVersion: 4.0.1 -#fhirVersion: 4.3.0 +#fhirVersion: 4.0.1 +fhirVersion: 4.3.0 copyrightYear: 2021+ releaseLabel: ci-build publisher: