Each of the following sections contain mapping tables, in the order in which they appear in the TSRs.
Trial Identification
| TSR Data Elements | XML Data Elements |
|---|---|
Trial Category | (Not included in the XML file) |
Trial Type | <study_type> |
NCI Trial Identifier | <secondary_id> |
| Other Trial Identifiers | <secondary_id> |
| Lead Organization (Trial) Identifier | <org_study_id> |
| ClinicalTrials.gov Identifier | (Not included in the XML file) |
| DCP Identifier | <secondary_id> |
| CTEP Identifier | <secondary_id> |
| CCR Identifier | (Not included in the XML file) |
| Duplicate NCI Identifier | <secondary_id> |
| Obsolete ClinicalTrials.gov Identifier | (Not included in the XML file) |
| Other Identifier | <secondary_id> |
| Amendment Date | (Not included in the XML file) |
| Amendment Number | (Not included in the XML file) |
General Trial Details
| TSR Data Elements | XML Data Elements |
|---|---|
| Type | <study_type> |
| Official Title | <official_title> |
| Alternate Title | (Not included in the XML file) |
| Brief Title | <brief_title> |
Acronym | <acronym> |
| Brief Summary | <brief_summary> |
| Detailed Description | <detailed_description> |
Keywords | <keyword> |
| Reporting Dataset Method | (Not included in the XML file) |
| Sponsor | <lead_sponsor> |
| Lead Organization | <overall_official> |
| Principle Investigator | <resp_party> |
| Responsible Party | <resp_party_type> |
| Overall Official | <overall_official> |
| Central Contact | <overall_contact> |
Status/Dates
| TSR Data Elements | XML Data Elements |
|---|---|
| Current Trial Status | <overall_status> |
| Trial Start Date | <start_date> |
| Primary Completion Date | <primary_compl_date> |
Trial Completion Date | <last_follow_up_date> |
Regulatory Information/Oversight Information
| TSR Data Elements | XML Data Elements |
|---|---|
| Studies a U.S. FDA-regulated Drug Product | <fda_regulated_drug> |
| Studies a U.S. FDA-regulated Device Product | <fda_regulated_device> |
| Unapproved/Uncleared Device? | <delayed_posting> |
| Post Prior to U.S. FDA Approval or Clearance | <post_prior_to_approval> |
| Pediatric Post-market Surveillance | <ped_postmarket_surv> |
| Product Exported from the U.S. | <exported_from_us> |
| FDA Regulated Intervention? | <is_fda_regulated> |
| Section 801? | <is_section_801> |
| DMC Appointed? | <has_dmc> |
| IND/IDE Study? | <is_ind_study> |
Human Subject Safety/Regulatory Authority
| TSR Data Elements | XML Data Elements |
|---|---|
| Board Approval Status | <approval_status> |
| Board Approval Number | <approval_number> |
| Board | <irb_info> |
| Affiliation | <affiliation> |
IND/IDE
| TSR Data Elements | XML Data Elements |
|---|---|
| Type | <ind_info> |
| Grantor | <ind_grantor> |
| Number | <ind_number> |
| Holder Type | (Not included in the XML file) |
| Holder | (Not included in the XML file) |
| Availability of Expanded Access | <has_expanded_access> |
| Expanded Access Record | <expanded_access_nct_id> |
NIH Grants
| TSR Data Elements | XML Data Elements |
|---|---|
| Funding Mechanism | <secondary_id> |
| NIH Institute Code | <secondary_id> |
| Serial Number | <secondary_id> |
| NCI Division/Program Code | <secondary_id> |
Data Table 4 Information
| TSR Data Elements | XML Data Elements |
|---|---|
| Funding Category | (Not included in the XML file) |
| Funding Sponsor/Source | (Not included in the XML file) |
| Program Codes | (Not included in the XML file) |
| Anatomic Site Code | (Not included in the XML file) |
Collaborators
| TSR Data Elements | XML Data Elements |
|---|---|
| Name | <collaborator> |
| Role | (Not included in the XML file) |
Disease/Condition
| TSR Data Elements | XML Data Elements |
|---|---|
| Name | <condition> |
Trial Design
| TSR Data Elements | XML Data Elements |
|---|---|
| Type | <study_type> |
| Primary Purpose | <interventional_subtype> |
| Secondary Purpose | (Not included in the XML file) |
| Phase | <phase> |
| Interventional Study Model | <assignment> |
| Model Description | <model_description> |
| Number of Arms | <number_of_arms> |
| Masking | <no_masking> |
| Masking Description | <masking_description> |
| Allocation | <allocation> |
| Target Enrollment | <enrollment> |
Eligibility Criteria
| TSR Data Elements | XML Data Elements |
|---|---|
| Accepts Healthy Volunteers? | <healthy_volunteers> |
| Sex | <gender> |
| Gender Based | <gender_based> |
| Gender Eligibility Description | <gender_description> |
| Minimum Age | <minimum_age> |
| Maximum Age | <maximum_age> |
| Inclusion Criteria | <criteria> |
| Exclusion Criteria | <criteria> |
Intervention(s)
| TSR Data Elements | XML Data Elements |
|---|---|
| Type | <intervention_type> |
| Name | <intervention_name> |
| Alternate Name | (Not included in the XML file) |
| Description | <intervention_description> |
Arm/Group(s)
| TSR Data Elements | XML Data Elements |
|---|---|
| Type | <arm_type> |
| Label | <arm_group_label> |
| Description | <arm_group_description> |
Primary and Secondary Outcome Measures
| TSR Data Elements | XML Data Elements |
|---|---|
| Title | <outcome_measure> |
| Description | <outcome_description> |
| Time Frame | <outcome_time_frame> |
Sub-groups Stratification Criteria
| TSR Data Elements | XML Data Elements |
|---|---|
| Label | (Not included in the XML file) |
| Description | (Not included in the XML file) |
Markers
| TSR Data Elements | XML Data Elements |
|---|---|
| Marker Name | (Not included in the XML file) |
| Evaluation Type | (Not included in the XML file) |
| Assay Type | (Not included in the XML file) |
| Biomarker Use | (Not included in the XML file) |
| Biomarker Purpose | (Not included in the XML file) |
| Specimen Type | (Not included in the XML file) |
Participating Sites
| TSR Data Elements | XML Data Elements |
|---|---|
| PO ID | (Not included in the XML file) |
| Facility | <facility> |
| Contact | <contact> |
| Recruitment Status and Dates | <status> |
| Target Accrual | (Not included in the XML file) |
| Investigator(s) | <investigator> |
