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Investigator-Initiated Clinical Trial Resources

Lock icon: This link will not work for public visitors.Some links will work for NIAID staff only.

Table of Contents

Is Your Research Covered by NIAID's Policy?

If you plan an investigator-initiated clinical trial, you must go through NIAID's process for the following awards:

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 Clinical Trial Planning Grant (R34). An R34 is not a prerequisite for either the R01 or U01.

* For NIAID's definition of risk, see How do I determine whether to apply for an R01 implementation grant or U01 implementation cooperative agreement?

Learn More About the Process

Request Prior Consultation

You are strongly encouraged to request prior consultation from program staff before you apply.

Prepare Your Application

In addition to the resources noted above, we have the following help for writing your application.

For more information, see NIAID Human Subjects Resources, including SOPs and questions and answers. Also learn more about Application and Peer Review.

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's policy on extending an investigator-initiated clinical trial, read the January 30, 2007, Guide notice and see the following pages:

NIAID Division Clinical Web Sites

Resources for NIAID Staff

For more information, see NIAID Human Subjects Resources. ​​

Last Updated February 18, 2015

Last Reviewed September 16, 2014