NIH Implementation of FDAAA

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

Identifying an "Applicable Clinical Trial" under FDAAA
  • This flow chart presents basic guidance on determining if a trial is considered an “applicable clinical trial” under FDAAA. It maps out the guidance provided in the "Elaboration of Definitions of Responsible Party and Applicable Clinical Trial" (PDF - 115 KB), and is also available as a PDF (393 KB).
  • This flow chart may not address every situation. The grantee's sponsored research office, general counsel, or other similar official should be involved in determining whether or not the grant supports an applicable clinical trial that needs to be registered under FDAAA.
Does the trial include a drug, biologic or device?

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 
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