“How do I determine level of risk when preparing an investigator-initiated clinical trial application?”

Funding News Edition: December 16, 2020
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NIAID considers your application “high risk” whenever you plan to provide a non-routine intervention—i.e., an intervention that would not otherwise be provided for the study condition in the facility where the trial is being conducted—or you plan to administer an unlicensed product or use a licensed product for an unapproved indication.

For an Investigator-Initiated Clinical Trial application, you should complete prior consultation with an NIAID program officer at least 10 weeks before the submission deadline. After Requesting Prior Consultation, discuss your determination of risk level for the proposed trial with the program officer.

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Email us at deaweb@niaid.nih.gov for help navigating NIAID’s grant and contract policies and procedures.

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