Grants Policy

NIH Implementation of FDAAA

Update: New HHS rule and NIH policy, effective January 18, 2017, affect all NIH-funded clinical trials. Read the summary.

Steps to Compliance for NIH Grantees

NIH grantees must take specific steps to ensure compliance with NIH implementation of FDAAA. Each step below provides guidance and includes links to FAQs and other sources including:

Click on the titles to display contents. Display All / Hide All

Step 1 Determine if the competing application or funded grant supports an applicable clinical trial that is required under FDAAA to be registered in
Step 2 Include a certification of compliance in the competing grant application and progress report.
Step 3 If the grant supports an applicable clinical trial, then determine which entity or individual is the responsible party.
Step 4 If the grantee is not the sponsor and therefore not the responsible party, contact the responsible party to ensure that the responsible party registers the trial and reports results as appropriate.
Step 5 The responsible party must register the applicable clinical trial no later than 21 days after enrolling the first subject.
Step 6 The responsible party must regularly update information in the applicable clinical trial record.
Step 7 If required, the responsible party must report summary results (including adverse event information) not later than 1 year after the trial completion date.

The NIH encourages registration and results reporting for all NIH-supported clinical trials, regardless of whether or not they are subject to FDAAA.

This page last updated on September 16, 2016 
Content Manager: 
Technical Issues: E-mail OER Webmaster