Planning Grants for Clinical Trials of High Relevance to the NIGMS Mission (R34)

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The purpose of this funding opportunity announcement is to permit early peer review of the scientific rationale for a proposed clinical trial, and to facilitate the complete submission of a subsequent research grant application to support the full scale clinical trial. The R34 planning grant mechanism is intended to provide time and support for an applicant to prepare, organize, and make oversight arrangements prior to consideration of an investigator-initiated application for a full clinical trial. Activities supported by a planning grant could include development of a Manual of Procedures, creation of a Data Safety and Monitoring Board charter, development of data handling and statistical analysis plans, establishment of recruitment sites, preparation of preliminary submissions for regulatory approvals, development of training materials, and other tasks essential to a trial. Following funding and successful completion of a planning grant, a clinical trial that is highly relevant to the institute's mission may be submitted to NIGMS as an R01 grant application.

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