In multi-center clinical research studies, does each study site have to meet the inclusion requirements separately?
NO. When multi-center clinical research studies are proposed, the inclusion requirements may be met by combining recruitment from the multiple sites. However, each clinical site must still describe its planned recruitment, retention and outreach plans, which will be evaluated as part of the initial review of the application or proposal. As part of its funding plan, the NIH may select recruitment sites with high minority and/or relevant subpopulation enrollments for inclusion in multi-center studies to achieve inclusion of the most diverse study population. See Question 4 under INFORMATION ON THE NIH PEER REVIEW PROCESS for additional discussion of contract projects.
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