Protocol Registration Data Element Definitions
for Interventional and Observational Studies

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October 1, 2020

This document describes the definitions for protocol registration data elements submitted to for interventional studies (clinical trials) and observational studies. These definitions are mostly adapted from 42 CFR Part 11.

Data element entries are annotated with symbols to indicate generally what information is required to be submitted (and under which circumstances). The responsible party must ensure that the information provided complies with any applicable laws, regulations, or policies. For more information about various requirements and definitions of regulatory terms under 42 CFR Part 11, see Support Materials.

Note: The term "clinical study" is used to refer to both interventional and observational studies. The term "participant" is used to refer to human subjects.

*   Required
*§   Required if Study Start Date is on or after January 18, 2017
[*]   Conditionally required

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

Responsible Party, by Official Title *
Definition: An indication of whether the responsible party is the sponsor, the sponsor-investigator, or a principal investigator designated by the sponsor to be the responsible party. Select one.

Note: The sponsor may designate a principal investigator as the responsible party if such principal investigator meets all of the following requirements: is responsible for conducting the study; has access to and control over the data from the study; has the right to publish the results of the study; and has the ability to meet all of the requirements for submitting and updating clinical study information.

Investigator Information [*]
If the Responsible Party, by Official Title is either "Principal Investigator" or "Sponsor-Investigator," the following is required:

Definition: The name of the entity or the individual who is the sponsor of the clinical study.
Limit: 160 characters.

Note: When a clinical study is conducted under an investigational new drug application (IND) or investigational device exemption (IDE), the IND or IDE holder is considered the sponsor. When a clinical study is not conducted under an IND or IDE, the single person or entity who initiates the study, by preparing and/or planning the study, and who has authority and control over the study, is considered the sponsor.

Definition: Other organizations (if any) providing support. Support may include funding, design, implementation, data analysis or reporting. The responsible party is responsible for confirming all collaborators before listing them.
Limit: 160 characters.

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. IPD Sharing Statement

13. References

A.1 Document Upload Information

A.2 Responsible Party Contact Information *§

History of Changes