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Clinical Research Policy Analysis and Coordination
  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.  
  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.  
  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)  
   The Food and Drug Administration (FDA)  
   The Department of Veterans Affairs  
   The Department of Defense (DOD)  
   Other Federal agencies that have adopted the Federal Policy for the Protection of Human Research Subjects.  
  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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