Steps to Compliance for NIH Awardees

NIH awardees must take specific steps to ensure compliance with NIH implementation of the NIH Policy on Dissemination of Clinical Trials Research and Section 801 of FDAAA, as implemented by 42 CFR Part 11. 

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Step 1

Determine if the competing application, contract proposal, funded grant, or awarded contract supports a clinical trial.

Step 2

Determine which regulations and/or policies apply to your NIH-funded clinical trial.

Step 3

Certify compliance in NIH grant applications, contract proposals and progress reports.

Step 4

Determine who is responsible for clinical trial registration and results reporting.

Step 5

Ensure the responsible entity registers the clinical trial no later than 21 days after enrolling the first subject.

Step 6

Ensure the responsible entity updates information in the clinical trial record at least once every 12 months.

Step 7

Ensure the responsible entity reports summary results not later than a year after clinical trial completion date.