NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)

The NIAID Clinical Trial Implementation Cooperative Agreement (PAR-27-064) is a funding opportunity for investigator-initiated, milestone-driven clinical trials that require enhanced oversight. These awards support trials for up to five years, with possible extensions to six or seven years for complex studies involving long follow-up periods or difficult recruitment. The program encourages the inclusion of mechanistic studies to improve the understanding of human diseases and the development of future therapeutic modalities. As a cooperative agreement, this is an assistance mechanism governed by 2 CFR Part 200 and 42 CFR Part 52 rather than standard federal acquisition regulations. Applications are evaluated through the NIH peer review system based on the importance of the research, rigor and feasibility of the approach, and the expertise of the investigators and their environment. Key requirements include the implementation of good clinical, laboratory, and manufacturing practices, and the submission of a comprehensive clinical protocol and informed consent forms. Awardees must maintain active SAM and eRA Commons registrations and adhere to strict cybersecurity incident reporting protocols, including notifying HHS within 48 hours of a discovery. Funding is contingent upon the availability of appropriated funds, and the agreement excludes automatic carryover or automatic extensions of the final budget period.