Grants and Funding
NIH Implementation of FDAAA
Certifying compliance with FDAAA in applications and progress reports

NIH grantees must certify compliance with FDAAA in applications and progress reports.

  • The certification of compliance with FDAAA required by the NIH is different than that required by the Food and Drug Administration (FDA).  To learn more about the FDA certification of compliance, please access the ClinicalTrials.gov Web site on Certification of Compliance to FDA.
For competing applications that include applicable clinical trial/s:

  • If a new applicable clinical trial is proposed -OR- if the grant will support an applicable clinical trial that is on-going but not yet required to register under FDAAA (e.g. less than 21 days have passed since enrollment of the first patient), the Human Subjects section of the Research Plan must include a clear statement, under a heading entitled “ClinicalTrials.gov”, that the project includes an applicable clinical trial which will require registration in ClinicalTrials.gov. 
    • Remember, FDAAA requires that applicable clinical trials be registered in ClinicalTrials.gov no later than 21 days after the first subject is enrolled.
  • If the competing application will support an applicable clinical trial that is registered in ClinicalTrials.gov, then the Human Subjects section of the Research Plan must include, under a heading entitled “ClinicalTrials.gov”, the ClinicalTrials.gov registry number (which is “NCT” followed by an 8-digit number, e.g. NCT00000418), the Brief Title (protocol title intended for the lay public), and the identity (name, organization) of the responsible party and their contact information (e-mail address-required for internal administrative use only).
  • The signature on the application of the Authorized Organizational Representative (Signing Official) assures compliance with FDAAA.
For non-competing continuation progress reports for a project that includes applicable clinical trial/s:

  • If a new applicable clinical trial is proposed -OR- if the progress report includes an applicable clinical trial that is on-going but not yet required to register under FDAAA (e.g. less than 21 days have passed since enrollment of the first subject), the Human Subjects section of the progress report must include a clear statement, under a heading entitled “ClinicalTrials.gov”, that the project includes an applicable clinical trial which will require registration in ClinicalTrials.gov. 
    • Remember, FDAAA requires that applicable clinical trials be registered in ClinicalTrials.gov no later than 21 days after the first subject is enrolled.
  • If the progress report includes an applicable clinical trial that is registered in ClinicalTrials.gov, then the Human Subjects section of the progress report must include, under a heading entitled “ClinicalTrials.gov”, the ClinicalTrials.gov registry number (which is “NCT” followed by an 8-digit number, e.g. NCT00000418), the Brief Title (protocol title intended for the lay public), and the identity (name, organization) of the responsible party and their contact information (e-mail address-required for internal administrative use only).
  • The signature on the non-competing continuation progress report of the Authorized Organizational Representative (Signing Official) assures compliance with FDAAA.

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 May 26, 2011
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