ClinicalTrialXMLREADME.md

Clinical Trial Data from ClinicalTrials.gov

Quick explanatory guide of the possible fields in one XML file

XML Conforms to this Schema which is updated regularly

Further explanation of important terms can be found here

{M} - field appears multiple times

{O} - field appears only once

{M?} - field may appear multiple times

{O?} - field may appear only once

• clinical_study {O} - all data about the clinical trial stored under this field including clinical_results
• required_header {O} - header that provides general info about the download
  • download_date {O} - date the data was downloaded
  • link_text {O} - the text that would display instead of the url if opened in a webpage
    • Says the same thing for each file
  • url {O} - where to find the data for the file online
• id_info {O} - different ways to classify the study id
  • org_study_id {O} - full id of the study
  • secondary_id {M} - shortened or different id to use to find the study
  • nct_id {O} - ClinicalTrials.gov identifier for the study (unique)
  • nct_alias {M} - alternate version of the nct_id
• brief_title {O} - title of the clinical trial
• acronym {O} - condensed abbreviation of the title
• official_title {O}
• sponsors {O} - wrapper
  • lead_sponsor {O} - wrapper
    • agency - organization running the clinical trial
    • agency_class - the type of the organization
      • Values: NIH, US Fed, Industry, Other
  • collaborator {M} - wrapper
    • agency - organization supporting the clinical trial that is not the sponsor
    • agency_class - the type of the organization
      • Values: NIH, US Fed, Industry, Other
• source {O} - who is funding the study
• oversight_info {O} - wrapper
  • has_dmc - whether or not the study has a data monitoring committee
    • Values: Yes, No
  • is_fda_regulated_drug
    • Values: Yes, No
  • is_fda_regulated_device
    • Values: Yes, No
  • is_unapproved_device
    • Values: Yes, No
  • is_ppsd
    • Values: Yes, No
  • is_us_export
    • Values: Yes, No
• brief_summary {O} - wrapper
  • textblock - short explanation of what the study is doing and looking to test
• detailed_description {O} - wrapper
  • textblock - more indepth explanation of the study, includes a lot more information than the breif summary
• overall_status {O} - potential values depend on the study_type
  • Study Type: Expanded Access - Values: Available, No Longer Available, Temporarily Not Available, Approved for Marketing
  • Study Type: N/A - Values: Withheld
  • Study Type: Anything Else - Values: "Active, not recruiting", Completed, Enrolling by invitation, Not yet recruiting, Recruiting, Suspended, Terminated, Withdrawn
• last_known_status {O} - most recent status of a study that has not been verified in at least 2 years
• why_stopped {O} - reason for discontinuing the study
• start_date {O}
• completion_date {O}
• primary_completion_date {O}
• phase {O} - current phase of the clinical trial (1-4)
  • Values: N/A, Early Phase 1, Phase 1, Phase 1/Phase2, Phase 2, Phase 2/Phase 3, Phase 3, Phase 4
• study_type {O} - classification of the study
  • Values: Expanded Acess, Interventional, N/A, Observational, Observational [Patient Registry]
• has_expanded_access {O} - does the clinical trial allow patients with immediately life threatening conditions to participate
  • Values: Yes, No
• expanded_access_info {O} - wrapper
  • expanded_access_type_individual
    • Values: Yes, No
  • expanded_access_type_intermediate
    • Values: Yes, No
  • expanded_access_type_treatment
    • Values: Yes, No
• study_design_info {O} - wrapper
  • allocation - how the tests are administered to the patients
    • Value: Randomized
  • intervention_model - general design of the strategy for assigning treatments to participants
  • intervention_model_description
  • primary_purpose - reason for the clinical trial
    • Values: Treatment
  • observational_model
  • time_persepective
  • masking - tells who knows which people were treated
  • masking_description
• target_duration {O} - optional - desired length of the study
• primary_outcome {M} - (outcome=endpoint) just a wrapper
  • measure - important for evaluating the effect of the treatment, what it is supposed to do
  • time_frame - how long it takes to see the outcome's effects
  • description
• secondary_outcome {M} - (outcome=endpoint) just a wrapper
  • measure - important for evaluating the effect of the treatment, what it is supposed to do
  • time_frame - how long it takes to see the outcome's effects
  • description
• other_outcome {M} - (outcome=endpoint) just a wrapper
  • measure - important for evaluating the effect of the treatment, what it is supposed to do
  • time_frame - how long it takes to see the outcome's effects
  • description
• number_of_arms {O} - number of groups/sub-groups in the clinical trial
• number_of_groups {O} - number of different overall trial goups (possibly)
• enrollment {O} - number of participants in the clinical study tagged with a type
  • Types: Actual, Anticipated, Estimate
• condition {M} - disease, disorder, etc being studied
• arm_group {M} - wrapper
  • arm_group_label {M} - treatment group
  • arm_group_type
    • Values: Experimental, Placebo Comparator
  • description
• intervention {M} - treatment
  • intervention_type - type of treatment
    • Values: Behavioral, Biological, Combination Product, Device, Diagnostic Test, Dietary Supplement, Drug, Genetic, Procedure, Radiation, Other
  • intervention_name - name of treatment
  • description
  • arm_group_label {M} - arm group associated with this treatment
  • other_name {M} - other way to identify the treatment
• biospec_retention {O} - wrapper
  • Values: None Retained, Samples With DNA, Samples Without DNA
• biospec_descr {O} - wrapper
• eligibility {O} - who can participate in the study
  • study_pop - population of the study
    • textblock
  • sampling_method
    • Values: Probability Sample, Non-Probability Sample
  • criteria
    • textblock - details about desired participants
  • gender
    • Values: Female, Male, All
  • gender_based
    • Values: Yes, No
  • gender_description
  • minimum_age
    • Format: XX Years
  • maximum_age
    • Format: XX Years
  • healthy_volunteers - Yes or No
• overall_official {M} - main point of contact for the clinical study
  • first_name
  • middle_name
  • last_name
  • degree
  • role
    • Values: Principal Investigator, Sub-Investigator, Study, Study Director
  • affiliation
• overall_contact {M?} - first person to call for more info about the study
  • first_name
  • middle_name
  • last_name
  • degrees
  • phone
  • phone_ext
  • email
• overall_contact_backup {M?} - second person to call for more info about the study
  • first_name
  • middle_name
  • last_name
  • degrees
  • phone
  • phone_ext
  • email
• location {M} - where the study is being conducted
  • facility - wrapper
    • name - name of the facility
    • address - wrapper
      • city
      • state
      • country
  • status
    • Values: "Active, not recruiting", Completed, Enrolling by invitation, Not yet recruiting, Recruiting, Suspended, Terminated, Withdrawn
  • contact {M?}
    • first_name
    • middle_name
    • last_name
    • degrees
    • phone
    • phone_ext
    • email
  • contact_backup {M?}
    • first_name
    • middle_name
    • last_name
    • degrees
    • phone
    • phone_ext
    • email
  • investigator {M}
    • first_name
    • middle_name
    • last_name
    • degree
    • role
      • Values: Principal Investigator, Sub-Investigator, Study, Study Director
    • affiliation
• location_countries {O} - countries the study is being conducted in
  • country {M}
• removed_countries {O} - countries no longer in the study
  • country {M}
• link {M} - wrapper
  • url - link to another website about this data
  • description
• reference {M} - sources of information for study
  • citation
  • PMID - unique identifier used in PubMed
• results_reference {M} - wrapper
  • citation
  • PMID - unique identifier used in PubMed
• verification_date {O} - most recent date that the study sponsor/investigator confirmed trial info is accurate
• study_first_submitted {O} - date of first submission to ClinicalTrials.gov
• study_first_submitted_qc {O} - date when study was consistent with NLM quality control review criteria
• study_first_posted {O} - date the study first appeared on ClinicalTrials.gov
• results_first_submitted {O} - date the summary results were first submitted to ClinicalTrials.gov
• results_first_submitted_qc {O} - date when study results were consistent with NLM quality control review criteria
• results_first_posted {O} - date the summary results first appeared on ClinicalTrials.gov
• disposition_first_submitted {O} - date the disposition was first submitted to ClinicalTrials.gov
• disposition_first_submitted_qc {O} - date when disposition was consistent with NLM quality control review criteria
• disposition_first_posted {O} - date the disposition first appeared on ClinicalTrials.gov
• last_update_submitted {O} - last date the sponsor/investigator submitted updates to the trial on ClinicalTrials.gov
• last_update_submitted_qc {O} - date when study was consistent with NLM quality control review criteria
• last_update_posted {O} - last date the sponsor/investigator updates were posted on ClinicalTrials.gov
• responsible_party {O?} - person responsible for submitting information about the study to ClinicalTrials.gov
  • name_title - only used in old style
  • organization - only used in old style
  • responsible_party_type
    • Values: Sponsor, Principal Investigator, Sponsor-Investigator
  • investigator_affiliation
  • investigator_full_name
  • investigator_title
• keyword {M} - keyword in the study
• condition_browse {O} - searchable conditions that this study would appear as a result of
  • mesh_term {M} - one condition
• intervention_browse {O} - searchable interventions that this study would appear as a result of
  • mesh_term {M} - one intervention
• patient_data {O} - information about the patients
  • sharing_ipd - whether or not they are sharing individual patient data
    • Values: Yes, No
  • ipd_description
  • ipd_info_type {M}
  • ipd_time_frame
  • ipd_access_criteria
  • ipd_url
• study_docs {O} - wrapper
  • study_doc {M} - wrapper
    • doc_id
    • doc_type
    • doc_url
    • doc_comment
• provided_document_section {O} - wrapper
  • provided_document {M} - wrapper
    • document_type
    • document_has_protocol
    • document_has_icf
    • document_has_sap
    • document_date
    • document_url
• pending_results {M} - appears only when the data provider has submitted study results for QC review, but those results have not yet been publicly posted
  • submitted - date
  • returned - date
  • submission_canceled - date

This section will only appear in the database as (Yes, No) of whether or not clinical_results exist in the study

• clinical_results - results of the clinical trial (within clinical study wrapper)
  • can appear multiple times
  • participant_flow
    • recruitment_details
    • pre_assignment_details
    • group_list
      • group - has only a group_id as an attribute
        • can appear multiple times
        • Values: P1, P2, P3, P4
        • title
        • description
    • period_list
      • period - can appear multiple times
        • title
        • milestone_list
          • milestone - can appear multiple times
            • title
            • participants_list
              • participants - has group_id (phase) and count (number of people) as attributes
        • drop_withdraw_reason_list
          • drop_withrow_reason - can appear multiple times
            • title
            • participants_list
              • participants - has group_id (phase) and count (number of people) as attributes
  • baseline
    • population
    • group_list
      • group - has only a group_id as attributes
        • can appear multiple times
        • Values: P1, P2, P3, P4
        • title
        • description
    • analyzed_list
      • analyzed
        • units - what is being analyzed (ex: Participants)
        • scope
        • count_list
          • count - has group_id similar to group above and count (number of units) as attributes
            • can appear multiple times
    • measure_list
      • measure - ???
        • can appear multiple times
        • title
        • description
        • population
        • units - what is being measured (ex: Participants, mL)
        • param - the purpose or final result of the measurement
          • Values: Geometric Mean, Geometric Least Squares Mean, Least Squares Mean, Log Mean, Mean, Median, Number, Count of Participants, Count of Units
        • dispersion - how the spread is being calculated
          • Values: 80% Confidence Interval, 90% Confidence Interval, 95% Confidence Interval, 97.5% Confidence Interval, 99% Confidence Interval, Full Range, Gemoetric Coefficient of Variation, Inter-Quartile Range, Standard Deviation, Standard Error
        • units_analyzed
        • analyzed_list
          • analyzed - can appear multiple times
            • units - what is being analyzed (ex: Participants)
            • scope
            • count_list
              • count - has group_id similar to group above and count (number of units) as attributes
                • can appear multiple times
        • class_list
          • class - can appear multiple times
            • title
            • • analyzed_list
                • analyzed - can appear multiple times
                  • units - what is being analyzed (ex: Participants)
                  • scope
                  • count_list
                  • count - has group_id similar to group above and count (number of units)
            • category_list
              • category - can appear multiple times
                • title
                • measurement_list
                  • measurement - has a group_id, value, spread, lower limit, upper limit as attributes
  • outcome_list
    • outcome - can appear multiple times
      • type
        • Values: Primary, Secondary, Other Pre-specified, Post-Hoc
      • title
      • description
      • time_frame
      • safety_issue
        • Values: Yes, No
      • posting_date
      • population
      • group_list
        • group - has only a group_id as attributes
          • can appear multiple times
          • Values: P1, P2, P3, P4
          • title
          • description
      • measure - ???
        • can appear multiple times
        • title
        • description
        • population
        • units - what is being measured (ex: Participants, mL)
        • param - the purpose or final result of the measurement
          • Values: Geometric Mean, Geometric Least Squares Mean, Least Squares Mean, Log Mean, Mean, Median, Number, Count of Participants, Count of Units
        • dispersion - how the spread is being calculated
          • Values: 80% Confidence Interval, 90% Confidence Interval, 95% Confidence Interval, 97.5% Confidence Interval, 99% Confidence Interval, Full Range, Gemoetric Coefficient of Variation, Inter-Quartile Range, Standard Deviation, Standard Error
        • units_analyzed
        • analyzed_list
          • analyzed - can appear multiple times
            • units - what is being analyzed (ex: Participants)
            • scope
            • count_list
              • count - has group_id similar to group above and count (number of units) as attributes
                • can appear multiple times
      • analysis_list
        • analysis - can appear multiple times
          • group_id_list
            • group_id - can appear multiple times
          • groups_desc
          • non_inferiority_type
            • Values: Superiority, Non-Inferiority, Equivalence, Other, Non-Inferiority or Equivalence, Superiority or Other
          • non_inferiority_desc
          • p_value
          • p_value_desc
          • method
          • method_desc
          • param_type
          • param_value
          • dispersion_type
            • Values: Standard Deviation, Standard Error of the Mean
          • dispersion_value
          • ci_percent
          • ci_n_sides
            • Values: 1-Sided, 2-Sided
          • ci_lower_limit
          • ci_upper_limit
          • ci_upper_limit_na_comment
          • estimate_desc
          • other_analysis_desc
  • reported_events
    • time_frame
    • desc
    • group_list
      • group - has only a group_id as attributes
        • can appear multiple times
        • Values: P1, P2, P3, P4
        • title
        • description
    • serious_events
      • frequency_thresold
      • default_vocab
      • default_assessment
      • category_list
        • category - can appear multiple times
          • title
          • event_list
            • event - can appear multiple times
              • sub_title
              • assessment
                • Values: Non-systematic Assessment, Systematic Assessment
              • description
              • counts - has group_id, subjects_affected, subjects_at_risk, events as attributes
                • can appear multiple times
    • other_events
      • frequency_thresold
      • default_vocab
      • default_assessment
      • category_list
        • category - can appear multiple times
          • title
          • event_list
            • event - can appear multiple times
              • sub_title
              • assessment
                • Values: Non-systematic Assessment, Systematic Assessment
              • description
              • counts - has group_id, subjects_affected, subjects_at_risk, events as attributes
                • can appear multiple times
  • certain_agreements
    • pi_employmee - whether or not all principal agents are employed by the sponsor of the study
      • Values: "All Principal Investigators ARE employed by the organization sponsoring the study.", "All Principal Investigators are NOT employed by the organization sponsoring the study."
    • restrictive_agreement
  • limitations_and_caveats
  • point_of_contact
    • name_or_title
    • organization
    • phone
    • email