Grants Policy

Further Resources for NIH Grantees

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

FAQs, Definitions and Acronyms
NIH Guide Notices
  • Clarification of Registration in According to Date of Initiation and Status as an “Ongoing” Trial - NOT-OD-10-007 (10/23/2009)
  • Clarification of NOT-OD-08-014 Regarding Obtaining Assistance from NIH for Registration and Reporting of Results in - NOT-OD-09-147 (09/04/2009)
  • Clarification of NOT-OD-08-014 and NOT-OD-08-023 Regarding Registration in - NOT-OD-09-030 (12/11/2008)
  • Clinical Trials Registration in (Public Law 110-85): Competing Applications and Non-Competing Progress Reports - NOT-OD-08-023 (12/21/2007)
  • Guidance on New Law (Public Law 110-85) Enacted to Expand the Scope of Registration - NOT-OD-08-014 (11/16/2007)

For Additional Information

  • For general inquiries or comments related to the Protocol Registration System (PRS), contact
  • Additional questions about the requirements may be directed to the NIH Office of Extramural Research at

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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