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.

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

Step 1	Determine if the competing application, contract proposal, funded grant, or awarded contract supports a clinical trial. Your human subject study may meet the NIH definition of a clinical trial. Use these four questions or our decision tool to see if your study meets the NIH definition of clinical trial: Question 1: Does the study involve human participants? If yes, then go to Question 2. If no, then STOP: Your application, proposal, funded grant or contract does NOT support a clinical trial and does not need to be compliant with clinical trial regulations and policies. Question 2: Are the participants prospectively assigned to an intervention? If yes, then go to Question 3. If no, then STOP: Your application, proposal, funded grant or contract does NOT support a clinical trial and does not need to be compliant with clinical trial regulations and policies. Question 3: Is the study designed to evaluate the effect of the intervention on the participants? If yes, then go to Question 4. If no, then STOP: Your application, proposal, funded grant or contract does NOT support a clinical trial and does not need to be compliant with clinical trial regulations and policies. Question 4: Is the effect that will be evaluated a health-related, biomedical, or behavioral outcome? If yes, then your study is a clinical trial as defined by NIH and needs to comply with clinical trial regulations and policies. If no, then STOP: Your application, proposal, funded grant or contract does NOT support a clinical trial and does not need to be compliant with clinical trial regulations and policies.
Step 2	Determine which regulations and/or policies apply to your NIH-funded clinical trial. Is your study an Applicable Clinical Trial? Visit Clinicaltrials.gov for the Checklist for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (ACT) to find out. If yes, then your study is subject to both FDAAA 801 as implemented by 42 CFR Part 11 (the Final Rule), and the NIH Policy on Dissemination of NIH Funded Clinical Trial Information. If no, then your study is subject to the NIH Policy on Dissemination of NIH Funded Clinical Trial Information.
Step 3	Certify compliance in NIH grant applications, contract proposals and progress reports. All competing applications (new and renewal), and contract proposals that include clinical trials must certify compliance. For grants, see application form instructions on the How to Apply - Application Guide page for specific guidance about certifying compliance. For progress reports for non-competing continuations, see progress report instructions to provide details on registration and reporting for both new clinical trials and existing clinical trials. These certifications of compliance submitted to the NIH are different than the certification required by the Food and Drug Administration (FDA). To learn more about the FDA certification of compliance, please access the FDA page on Certification of Compliance to FDA.
Step 4	Determine who is responsible for clinical trial registration and results reporting. NIH-funded clinical trial is subject to FDAAA and the Final Rule (i.e., supports an ACT): FDAAA defines the responsible party as: (1) the sponsor of the clinical trial (as defined in 21 CFR 50.3), or (2) the principal investigator of such clinical trial if so designated by a sponsor, recipient, contractor, or awardee (provided that “the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements” for submitting information under the law.) See PL 110-85, Section 801(a) (PDF - 549 KB), (adding new 42 U.S.C. 282(j)(1)(A)(ix)). See also the FDAAA definition of responsible party. NIH-funded clinical trial is subject only to the NIH Policy (i.e., supports a clinical trial but not an applicable clinical trial): the entity responsible for registering and reporting results is the recipient or investigator. NOTE: If you are not the responsible entity, contact the responsible entity to ensure that the clinical trial is registered and results are reported as appropriate
Step 5	Ensure the responsible entity registers the clinical trial no later than 21 days after enrolling the first subject. Visit clinicaltrials.gov for information on how to register your study in the Clinicaltrials.gov Protocol Registry System (PRS).
Step 6	Ensure the responsible entity updates information in the clinical trial record at least once every 12 months. Visit Clinicaltrials.gov for information on how to edit your study in the Clinicaltrials.gov Protocol Registry System (PRS).
Step 7	Ensure the responsible entity reports summary results not later than a year after clinical trial completion date. Visit Clinicaltrials.gov for information on how to submit your results in the clinicaltrials.gov Protocol Registry System (PRS). Note: 42 CFR Part 11 describes several circumstances under which the results reporting submission for an ACT may be extended past one year. Please refer to 42 CFR Part 11 for details about results reporting submission requirements for ACT.