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The National Institutes of Health (NIH), as the primary Federal agency for the support of clinical research, is responsible for promoting the efficiency and effectiveness of the clinical research enterprise.
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Under the NIH Roadmap, the NIH has thus established the Clinical Research Policy Analysis and Coordination (CRpac) Program to serve as a focal point for the ongoing harmonization, streamlining, and optimization of policies and requirements concerning the conduct and oversight of clinical research.
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CRpac staff work closely with other Federal agencies and offices that have responsibilities concerning the oversight of clinical research, including:
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The Office of Human Research Protections (OHRP)
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The Food and Drug Administration (FDA)
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The Department of Veterans Affairs
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The Department of Defense (DOD)
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Other Federal agencies that have adopted the Federal Policy for the Protection of Human Research Subjects.
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The CRpac Program addresses a wide range of topics including adverse event reporting, clinical trial design, safety monitoring, IRB review models, informed consent, and the use of human specimens in research.
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