Sunday, April 11, 2010

CDER's Role in FDA's BIMO, DSI and GCP Goals

CDER's role in FDA's Bioresearch Monitoring (BIMO) Programs and Human Subject Protection primarily focus on 4 areas which are Compliance, DSI Manufacturing/Product Quality, Compliance Risk Management/Surveillance and the Division of New Drugs/Labeling Compliance.
In an earlier post, goals of CDER's BIMO were clarified and presented.

What are the goals of CDER's FDA's DSI and GCP divisions?

DSI - For the Review Divisions -
  • DSI will arrange for routine data audit GCP inspections to determine data quality, data integrity and safety of subjects in pivotal clinical trials and provide the inspection reports to the review division prior to the Division Action Goal Date.

DSI - For the Public -

  • DSI will investigate complaints related to the conduct of clinical trials, including arranging for directed or "for cause" inspections and take appropriate regulatory action.
  • DSI will arrange for routine surveillance inspections of IRBs to determine if rights, safety and welfare of human subjects are protected.


  • Issue assignments to the Office of Regulatory Affairs (ORA) field investigators and participate on inspection when expertise is required.
  • Evaluate the results of inspections from a scientific and regulatory perspective.
  • Recommend and implement regulatory actions.
  • Provide expert advice on program design, policy issues and guidance.
  • Educate and inform program constituents - communication within CDER, FDA, otherwise.

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