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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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The Clinical Research Policy Analysis and Coordination (CRpac) Program is an important initiative of the NIH Roadmap, which aims to improve the efficiency, organization and advancement of medical research. To accelerate and strengthen the clinical research process in the 21st century, CRpac has an important role in re-engineering the clinical research enterprise.
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CRpac serves as a focal point for ongoing harmonization, streamlining, and optimization of policies and requirements concerning the conduct and oversight of clinical research.
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The CRpac Program addresses a wide range of topics including:
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Adverse Event Reporting
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Clinical Trial Design
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Clinical Trials Monitoring
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Human Data and Specimens on Research
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Human Subjects Regulations
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Informed Consent
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Models of IRB Review
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The CRpac program is located in the Office of Biotechnology Activities (OBA) which is housed with in the Office of Science Policy in the Office of the NIH Director.
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The CRpac staff work closely with other Federal agencies and offices that have responsibilities concerning the oversight of clinical research including:
The Office of Human Research Protections (OHRP) and The Food and Drug Administration (FDA).
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