The NIH Policy on Dissemination of NIH-Funded Clinical Trial Information details the reporting expectations to ClincialTrials.gov for all NIH-funded clinical trials.
- The NIH policy applies to all clinical trials funded by NIH, regardless of study phase, type of intervention, or whether they are subject to the regulation.
- The goal of the new regulation and policy is to increase the availability of information about clinical trials to the public.
Accordingly, all NIDCD-funded clinical trials should include a plan for registration and be registered and updated at ClinicalTrials.gov as follows:
- Grant application package: Applicants for NIH funding are required to submit a plan with their application that outlines how they will comply with the clinical trial information dissemination expectations of the policy. This information should be included in the PHS Human Subjects and Clinical Trials Information Form, section 4.7: Dissemination Plan.
Initial registration: Registration should be no later than 21 calendar days after the enrollment of the first participant.Note: In circumstances when an NIDCD-funded clinical trial has not yet enrolled participants, we recommend that investigators complete the ClinicalTrials.gov registration prior to the submission deadline of the first annual progress report.
- Results: Updates with results should occur no later than one year after the trial's primary completion date. The policy does allow, in certain circumstances, for delayed submission of results information (up to two additional years) for trials of products regulated by the FDA that are unapproved, unlicensed, or uncleared, or for trials of products for which approval of a new use is being sought.
Additional Registration Instructions for NIDCD-Funded Clinical Trials
When registering your clinical trial on the ClinicalTrials.gov website, please be sure to enter the full NIH project ID number in the “Other Study ID Number” field, e.g., 5U01DC013529 (U.S. NIH grant/contract). This will link your clinical trial to the NIH Research Portfolio Online Reporting Tools (RePORT).