FDA & OHRP Inspections

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Please notify UCSF upon receiving the call or letter from the FDA to schedule the inspection. The following officials can provide support and guidance for your inspection: IRB (Taylar Hagan), Legal Affairs (Ann Sparkman), FDA Regulatory Support, and Office of Ethics and Compliance.

For studies conducted at the CRCs, please include CTSI Clinical Research Services Administrative Associate Director (Carmela Lomonaco).

The following general guidelines are recommended during an FDA inspection from the time the FDA inspector is greeted to the time the exit interview is conducted and a response to the FDA’s observations are made. 

  • Investigators are required to permit the FDA to inspect and copy any records pertaining to the investigation including, in certain situations, those which identify subjects
  • Designate a person to serve as escort who will oversee the inspection (usually the research coordinator for the study) 
  • The escort serves as an institutional monitor as well as guide and general study contact person
  • The FDA investigator must not be permitted free access to areas where files are kept