ClinicalTrials.gov Protocol Data Element Definitions (DRAFT)

September 2014



*   Required by ClinicalTrials.gov
FDAAA   Required to comply with Food and Drug Administration Amendments Act (FDAAA), Section 801
(FDAAA)   May be required to comply with FDAAA, Section 801

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups and Interventions

9. Outcome Measures

10. Eligibility

11. Contacts, Locations, and Investigator Information

12. References