High-Risk Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Required)
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This Notice of Funding Opportunity (NOFO) invites applications for investigator-initiated, high-risk clinical trials that will involve multiple clinical centers. The proposed trials must be hypothesis-driven, have the potential to change clinical practice and/or public health, and focus on diseases within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Planning activities must be completed prior to submission and are not permitted under this NOFO; applicants needing a planning phase may apply for a U34 implementation planning cooperative agreement. Consultation with NIDDK Scientific/Research staff prior to submitting either a U34 or U01 application is strongly encouraged. This opportunity is open to various eligible applicants, including but not limited to, for-profit organizations other than small businesses, state governments, private institutions of higher education, small businesses, public and state institutions of higher education, and non-profit organizations. Foreign components are allowed, but non-domestic (non-U.S.) entities are not eligible to apply.
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