Registration Data Element Definitions
for Expanded Access

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October 1, 2020

This document describes the definitions for registration data elements submitted to for expanded access records. Such records provide information about investigational products that are made available through expanded access for patients who do not qualify for enrollment in a clinical trial. For investigational drug products (including biological products) this includes all expanded access types under section 561 of the Federal Food, Drug, and Cosmetic Act: (1) for individual patients, including emergency use; (2) for intermediate-size patient populations; and (3) under a treatment IND or treatment protocol.

Only one expanded access record should be created for any given investigational product, even if the investigational product is being made available for individual patient expanded access (that is, the responsible party should not create an expanded access record for each instance of individual patient access).These definitions for expanded access records 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 some of the relevant requirements, see Support Materials.

*   Required
*§   Required if initial submission 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:

  • Investigator Name: Name of the investigator, including first and last name

  • Investigator Official Title: The official title of the investigator at the primary organizational affiliation
    Limit: 254 characters.

  • Investigator Affiliation: Primary organizational affiliation of the individual
    Limit: 160 characters.

Definition: The name of the entity that is the sponsor of the expanded access
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.

Definition: Other organizations (if any) providing support, including funding, design, implementation, data analysis and 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. Interventions

8. Eligibility

9. Contacts, Locations, and Investigator Information

10. References

History of Changes