Protocol Data Element Definitions (DRAFT)

August 20, 2008

*   Required by
FDAAA   Required to comply with US Public Law 110-85, Section 801
(FDAAA)   May be required to comply with US Public Law 110-85, Section 801

1. Titles and Background Information

2. US Food and Drug Administration (FDA) Information 3. Human Subjects Review Submitted studies must have approval from a human subjects review board prior to the recruitment of the first patient. Appropriate review boards include an Institutional Review Board, an ethics committee or an equivalent group that is responsible for review and monitoring of this protocol to protect the rights and welfare of human research subjects. A study may be submitted for registration prior to approval of the review board so long as the study is not yet recruiting patients.

Review board information is desired but not required for trials associated with U.S. FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications.

Review board information is required for internal administrative use and is not revealed to the public.

Oversight authority information is displayed on For IND/IDE protocols, Oversight Authority is filled in automatically with "United States: Food and Drug Administration."

4. Sponsors

5. Study Description
6. Status 7. Study Design

8. Arms, Groups and Interventions 9. Conditions and Keywords

10. Eligibility

11. Protocol Location, Contact and Investigator Information

Multiple locations may be specified. Location is composed of the following fields.

12. Related Information