Investigator-Initiated Clinical Trial Resources

If you haven’t done so already, check NIAID’s Clinical Trial Research page and confirm whether your planned research meets NIH’s definition of a clinical trial. Then read this page for NIAID’s unique requirements for investigator-initiated clinical trials (IICTs).

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Follow the NIAID IICT Process

To apply for your own clinical trial outside of NIAID’s Networks, you must follow NIAID’s rules and process for IICTs as described below. Otherwise, we will not accept your application.

Start with NIAID’s Investigator-Initiated Clinical Trial Planning and Implementation Awards SOP, then read the Investigator-Initiated Clinical Trial Awards—General Questions and Answers and other IICT Questions and Answers.

Decide which FOA best suits your research:

*For the NIAID definition of high risk, see How do I determine level of risk and choose an award type for my application?

If you need support to get ready for the launch of an IICT, such as planning, designing, and preparing the documentation necessary for implementing an IICT, consider applying first for a NIAID Clinical Trial Planning Grant (R34). An R34 is not a prerequisite for any other clinical trial award.

Then, at least 10 weeks before your application’s due date, speak to the scientific/research contact listed on the FOA to request a prior consultation.

The purpose of this consultation is four-fold:

  1. Assure you that your proposed clinical trial meets NIAID’s goals, fits within our mission, and addresses a high priority research area
  2. Determine the risk level of your proposed trial
  3. Review the information and documents you’ll need to include in your application
  4. Identify other mechanisms to support your clinical trial, e.g., through a different funding opportunity announcement or one of our clinical trial networks

Prepare for that discussion using our guide, Requesting Prior Consultation to Discuss Submission of a NIAID Clinical Trial Application.

Last, write your application and gather all documentation you’ll need when you apply. Learn more and get advice at NIAID’s What’s Special About Clinical Trial Applications?

What To Do If You Need an Extension After Award

If you can't complete a clinical trial by the end of the award, you may be able to apply for an extension. For NIAID policy on extending an IICT, read the following pages:

IICT Resources for Staff and Applicants

In addition to the websites noted above, we have the following resources to help you with your application:

For more information, see NIAID Human Subjects Resources, which includes SOPs and questions and answers. Also learn more about how to Apply for a Grant and First-Level Peer Review.

We also advise you to review NIAID’s clinical research policies. These policies may differ somewhat depending on your research and topic area.

Content last reviewed on February 19, 2019