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)Â |
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> |