Guide to FDAAA Reporting Research Results

Those in the IRP responsible for specified clinical trials of FDA-regulated products are required to submit registration information to ClinicalTrials.gov (external link), summary results information for clinical trials of approved products, and adverse events information, according to the provisions of the FDA Administrations Act (FDAAA (PDF file)) of 2007, section 402(j) of the Public Health Service Act (PHS Act) (42 U.S.C. 282(j) (external link)) and the Final Rule CFR 81 (September 16, 2016).

While NIH Office of Protocol Services (OPS) (external link) assists with Registration, the Responsible Party named in the Registration, is expected to make sure that Research Results are posted to ClinicalTrials.gov within one year of the trial completion date. In addition, the Responsible Party named in the Registration is responsible for providing information periodically as needed for NIH IRP data-calls.

NIH Policies Related to the FDAAA NPRM

The NIH Policy on FDAAA requirements applied to extramurally funded Clinical Trials also applies to the Intramural Research Program (IRP).

• Clinical Trial Requirements for Grants & Contracts (external link)
• Notice of Revised NIH Definition of “Clinical Trial” (PDF file)
  • Decision Tree for NIH Clinical Trial Definition (PDF file)
• Frequently Asked Questions (FAQs): NIH Clinical Trial Definition
• NIH Definition of Clinical Trial Case Studies (external link)
• Assistance Available to Help with Results Reporting to ClinicalTrials.gov