NIAMS Clinical Trial Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required) (PAR-24-208)

This Notice of Funding Opportunity Announcement (NOFO) solicits cooperative agreement (UG3/UH3) applications for implementation of investigator-initiated, single or multi-site, interventional clinical trials (all phases). Investigators who have completed all necessary preparation (e.g., the trial design, protocol synopsis, data analysis plan, etc.) through other means may apply for a NIAMS UG3/UH3. The UG3 phase is designed to allow the investigators to prepare the final aspects needed to start the trial, (e.g., establishing the single IRB (sIRB), contracts and reliance agreements with sites, hiring of staff, etc.). Transition to the UH3 phase to begin the trial is dependent upon completion of the UG3 milestones proposed by the investigator and approved by NIAMS. UG3 projects that meet their milestones will be administratively considered by NIAMS and prioritized for transition to the UH3 phase. NIAMS expects trials to be hypothesis-driven and have the potential for high clinical impact within the research mission of NIAMS.