NIDDK High Risk Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional)

The National Institutes of Health (NIH) is seeking applications for a cooperative agreement to support the implementation planning of high-risk, multi-center clinical studies. The proposed clinical study should be hypothesis-driven and focus on a disease within the mission of NIDDK. The U34 is designed to permit early peer review of the rationale for the proposed clinical study, assessment of the design and protocol, and provide support for the development of essential elements required for the conduct of the clinical study. Key aspects of the job include: * Developing documents needed for the conduct of the study, including a manual of operations * Supporting the development of other essential elements required for the conduct of the clinical study * Permitting early peer review of the rationale for the proposed clinical study * Assessing the design and protocol of the proposed study * Focusing on a disease within the mission of NIDDK * Being hypothesis-driven * Being a high-risk, multi-center clinical study * Providing support for the development of essential elements required for the conduct of the clinical study.