October 1, 2020
This document describes the definitions for registration data elements submitted to ClinicalTrials.gov 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 |
Brief Title
*
Definition: A short title identifying the expanded access, written in language intended for the lay public.
Limit: 300 characters.
Acronym
[*]
Definition: An acronym or abbreviation used publicly to identify the expanded access, if any.
Limit: 14 characters.
Official Title
[*]
(Optional if Expanded Access Type is "Individual Patients")
Definition: The title of the expanded access program corresponding to the title that has been submitted to the U.S. Food and Drug Administration (FDA) for that program, if any.
Limit: 600 characters.
Secondary ID
[*]
(Optional if Expanded Access Type is "Individual Patients")
Definition: An identifier(s) (ID), if any, other than the organization's Unique Protocol Identification Number or the NCT number that is assigned to the expanded access record. This includes any unique identifier assigned by other publicly available clinical trial or expanded access registries.
Limit: 30 characters.
If there is a Secondary ID, then the following information must be provided:
Limit: 119 characters.
Description
[*]
Definition: If a Secondary ID Type of "Other Grant/Funding Number," "Registry Identifier," or "Other Identifier" is selected, provide the name of the funding organization, clinical trial registry, or organization that issued the identifier.
Study Type
*
Definition: The nature of the investigation or investigational use for which clinical study information is being submitted. Select the "Expanded Access" menu item. (For more information on data requirements for Interventional or Observational Study Types, see Protocol Registration Data Element Definitions).
Expanded Access Type
*§
Definition: The type(s) of expanded access for which the investigational drug product (including a biological product) is available, as specified in U.S. Food and Drug Administration (FDA) regulations. Select all that apply.
Record Verification Date
*
Definition: The date on which the responsible party last verified the information in the entire expanded access record, even if no additional or updated information is being submitted.
Expanded Access Status
*
Definition: The status of availability of the investigational drug product (including a biological product) through expanded access. Select one.
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.
Investigator Information
[*]
If the Responsible Party, by Official Title is either "Principal Investigator" or "Sponsor-Investigator," the following is required:
Name of the Sponsor
*
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.
Collaborators
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.
Investigational New Drug Application (IND)/Investigational Device Exemption (IDE) Information
Definition: Complete the following information regarding an IND or IDE for the expanded access as defined under U.S. Food and Drug Administration (FDA) regulations in 21 CFR 312.3 or 21 CFR 812, respectively.
FDA Center
[*]
Definition: The name or abbreviation of the FDA center with which the IND or IDE is filed. Select one. (Will not be made public - for administrative purposes only.)
IND or IDE Number
[*]
Definition: IND or IDE number assigned by the FDA center. (Will not be made public - for administrative purposes only.)
IND Serial Number
[*]
Definition: For an IND, the IND serial number, as defined in 21 CFR 312.23(e), if any, assigned to the expanded access.
(Will not be made public - for administrative purposes only.)
Keywords
Definition: Words or phrases that best describe the expanded access. Keywords help users find studies in the database. Use NLM's Medical Subject Heading (MeSH)-controlled vocabulary terms where appropriate. Be as specific and precise as possible. Avoid acronyms and abbreviations.
Note: "Sex" means a person's classification as male or female based on biological distinctions.
Note: "Gender" means a person's self-representation of gender identity.
Maximum Age
[*]
Definition: The numerical value, if any, for the maximum age a patient can be to be eligible for the expanded access.
Facility Contact
Definition: For each facility participating in in providing expanded access to an investigational drug product, the following information:
Description
Definition: Title or brief description of the linked page.
Limit: 254 characters.
Note: "Responsible party" means with respect to a clinical study, the sponsor of the clinical study, as defined in 21 CFR 50.3; or the principal investigator of such clinical study if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the study, has access to and control over the data from the clinical study, has the right to publish the results of the study, and has the ability to meet all of the requirements for the submission of clinical study information. For a pediatric postmarket surveillance of a device product that is not a clinical trial, the responsible party is the entity who FDA orders to conduct the pediatric postmarket surveillance of the device product.