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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.  
  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.  
  CRpac serves as a focal point for ongoing harmonization, streamlining, and optimization of policies and requirements concerning the conduct and oversight of clinical research.  
  The CRpac Program addresses a wide range of topics including:  
   Adverse Event Reporting  
   Clinical Trial Design  
   Clinical Trials Monitoring  
   Human Data and Specimens on Research  
   Human Subjects Regulations  
   Informed Consent  
   Models of IRB Review  
  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.  
  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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