Clinical Trials

Before you submit your grant application or contract proposal that includes a clinical trial for NIH funding, and as you become involved in clinical trials research, learn about new NIH initiatives throughout the clinical trial lifecycle, from idea to results reporting.
 
On This Page:
Good Clinical Practice training Clinical trial-specific funding opportunity announcements Grants application form changes Single IRB policy Protocol template Expanded Clinicaltrials.gov registration and results submission policy

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Good clinical practice training Link to Non-U.S. Government Site - Click for Disclaimer

NIH expects all NIH-funded investigators who are involved in the conduct, oversight, or management of clinical trials to be trained in Good Clinical Practice (GCP). Learn more by reading the policy Link to Non-U.S. Government Site - Click for Disclaimer and reviewing the FAQs Link to Non-U.S. Government Site - Click for Disclaimer .

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Clinical trial-specific funding opportunities

Grant applications and contract proposals involving clinical trials submitted for due dates on or after January 25, 2018, must be submitted to a funding opportunity announcement (FOA) or request for proposal that explicitly states it will accept clinical trials.  After this date the NIH will no longer accept clinical trial applications through “parent” announcements or through other FOAs that are not specifically designed to accept clinical trials. Learn more by reading the full policy.

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Grant application form changes

We will be expanding and using discrete form fields for clinical trial information to provide the level of information needed for peer review; lead applicants through clinical trial information collection requirements; present key information to reviewers and agency staff in a consistent format; and align with ClinicalTrials.gov where possible to position us for future data exchange with ClinicalTrials.gov. Learn more.

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Single IRB policy

As of January 25, 2018, if you are conducting a multi-site NIH-funded study involving non-exempt human subjects research, you are expected to use a single Institutional Review Board (sIRB) to conduct the ethical review. Learn more Link to Non-U.S. Government Site - Click for Disclaimer .  

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Clinical trials protocol template Link to Non-U.S. Government Site - Click for Disclaimer

If your application includes phase 2 or 3 clinical trials that require Investigational New Drug application (IND) or Investigational Device Exemption (IDE) applications, a NIH-FDA template with instructional and sample text can help you in writing your protocols. Learn more Link to Non-U.S. Government Site - Click for Disclaimer .

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Clinicaltrials.gov registration and reporting

What you need to know about requirements for registering and reporting your NIH-funded clinical trial on clinicaltrials.gov. Learn more.