The National Institutes of Health (NIH), specifically through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), is issuing a funding opportunity for high-risk multi-center clinical study implementation planning via U34 Cooperative Agreements. This initiative supports early peer review and preparation for investigator-initiated clinical studies focusing on NIDDK mission-related diseases. The U34 phase aids in administrative planning, including development of protocols, operational manuals, and recruitment strategies, which are pivotal before participant recruitment begins. Notably, a Plan for Enhancing Diverse Perspectives (PEDP) is required, emphasizing inclusivity in the research process. Applications should demonstrate sufficient engagement with diverse communities and meet specific review criteria relating to significance, investigator qualifications, innovation, and approach. The maximum funding per year is $225,000 for a project period of up to two years. Important key dates include an opening application date of September 9, 2024, with all applications due by 5:00 PM local time on respective due dates, ensuring timely submission via Grants.gov or NIH systems. Compliance with detailed application instructions is strictly enforced, and applications must emphasize administrative milestones and strategies to strengthen research inclusivity.