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

The National Institute of Allergy and Infectious Diseases (NIAID) is seeking applications for investigator-initiated, milestone-driven clinical trials that need enhanced oversight. The program encourages cooperative agreement applications for implementation of clinical trials, including mechanistic studies associated with these clinical trials. The program encompasses both basic and clinical research, and support is available for clinical trials up to 5 years, as well as for extended clinical trials of 6- or 7-years. Key responsibilities of the recipient include designing and conducting the clinical trial, ensuring that each clinical site follows the procedures required by the protocol, and submitting a clinical close-out plan to NIAID staff within two months of the decision that an awarded study is no longer feasible. • The recipient will be responsible for the overall conduct of the clinical trial, including designing and conducting the trial, and ensuring that each clinical site follows the procedures required by the protocol. • The recipient will be required to submit a clinical close-out plan to NIAID staff within two months of the decision that an awarded study is no longer feasible. • The recipient will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.