NIAID Clinical Trial Implementation (U01) Cooperative Agreement

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Beginning with the May 1, 2006 receipt date for AIDS applications and the June 1, 2006 receipt date for non-AIDS applications, NIAID will accept, peer review, and consider for funding applications for implementation of investigator-initiated clinical trials only from NIAID Clinical Trial Planning (R34) grant awardees (See PAR-05-112 for information on NIAID Clinical Trial Planning Grants). Each clinical trial implementation application will use the PHS 398 grant application with special instructions and will include a copy of the Institutional Review Board (IRB) approved study protocol, investigators brochure or equivalent, and a manual of operations or equivalent. These documents must meet all National Institutes of Health (NIH), Food and Drug Administration (FDA), and Office of Human Research Protections (OHRP) requirements. All awards will be made as cooperative agreements. In order not to delay the initiation of the clinical trial, the peer review and award of the clinical trial implementation grant will be completed within four months of the receipt of the application.

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