The Office of Research Integrity

Clinical Trials & Related Requirements

September 2016: The NIH issued a final policy to promote broad and responsible dissemination of information from NIH-funded clinical trials through ClinicalTrials.gov. Under this policy, every clinical trial funded in whole or in part by NIH is expected to be registered on ClinicalTrials.gov and have summary results information submitted and posted in a timely manner, whether subject to FDAAA 801 or not. This policy is effective for applications for funding, including grants, other transactions, and contracts submitted on or after January 18, 2017. For the NIH intramural program, the policy applies to clinical trials initiated on or after January 18, 2017. NIH issued a final policy to promote broad and responsible dissemination of information from NIH-funded clinical trials through ClinicalTrials.gov. Under this policy, every clinical trial funded in whole or in part by NIH is expected to be registered on ClinicalTrials.gov and have summary results information submitted and posted in a timely manner, whether subject to FDAAA 801 or not. This policy is effective for applications for funding, including grants, other transactions, and contracts submitted on or after January 18, 2017. For the NIH intramural program, the policy applies to clinical trials initiated on or after January 18, 2017.