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FDAAA for NIH Grantees: The Basics
This page provides a basic introduction to FDAAA specifically for NIH grantees. Review the entire website for fuller information about the statute and roles and responsibilities for compliance.
Overview of FDAAA
The Food and Drug Administration Amendments Act of 2007 (FDAAA) (PDF - 540 KB), Title VIII, expands the National Library of Medicine (NLM) clinical trials registry and results database known as ClinicalTrials.gov and imposes new requirements that apply to certain trials supported by NIH funds.
Trials subject to FDAAA are called “applicable clinical trials” (ACTs; see Definitions). Any ACT supported in whole or in part by an NIH grant (including cooperative agreements) must be in full compliance with FDAAA.
The trial’s “responsible party” (see Definitions) is responsible for two basic elements of compliance:
A third basic element of compliance specific to the NIH implementation of FDAAA is a requirement for all NIH grantees, regardless of whether or not they are the “responsible party” under FDAAA:
To help understand if a grant supports an ACT and which entity or individual is the responsible party for the trial, please review “Steps to Compliance for NIH Grantees.”
The entity responsible for registering the trial is the “responsible party.” The statute defines the responsible party as the sponsor (see Definitions) of the trial, or the principal investigator of the trial if designated so by the sponsor. Under grants: