Clinicaltrials.gov Program

Suggested language for National Institutes of Health grants

If you are seeking funding for a National Institutes of Health clinical trial, you are required to provide a plan describing how the expectations of the National Institutes of Health policy will be met. Examples of the grant language listed here:

ClinicalTrials.gov Dissemination Plan: The principal investigator will abide by the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information. The investigator intends to register the trial, maintain and update the record, and submit results information to ClinicalTrials.gov, consistent with policy and regulatory requirements. The Indiana University Office of Research Compliance, in collaboration with the Indiana CTSI, offers a robust compliance program and provides guidance to investigators in meeting their policy and regulatory obligations.

ClinicalTrials.gov Dissemination Plan: The investigator intends to coordinate with the lead principal investigator to ensure that all regulatory and policy requirements are met in compliance with the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information. The investigator intends to provide necessary information to the lead PI to facilitate registering the trial, maintaining and updating the record, and submitting results information to ClinicalTrials.gov. The Indiana University Office of Research Compliance, in collaboration with the Indiana CTSI, offers a robust compliance program and provides guidance to investigators in meeting their policy and regulatory obligations.