NIH issued 3 notices that impact NIH funded Clinical Trials.  These notices implement the DHHS’s new rulings but with expanded application to all NIH Funded clinical trials.  The following is a summary of the 3 notices for your information.  Please note that the Good Clinical Practice training is effective January 1, 2017.

  • Expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials be trained in Good Clinical Practice (GCP). – Effective January 1, 2017 NOT-OD-16-148
  • Expectation that all NIH-funded clinical trials are registered and that results are submitted to ClinicalTrials.gov whether or not subject to FDAAA. – Applies to grants, contracts, and intramural clinical trials submitted on or after January 18, 2017. NOT-OD-16-149
  • Requires all applications involving one or more clinical trials to be submitted in response to a clinical-trial specific FOA. –  Effective for receipt date on or after September 27,2017 NOT-OD-16-147

NIH Definition of Clinical Trials

NIH FAQ

Steps to Compliance for NIH Grantees