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Are FDA inspections of clinical investigator sites announced or unannounced?

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Both. They occur for any of the following reasons:

  • to verify data that has been submitted to the agency
  • if any complaints have been submitted in regard to that particular investigational site
  • if any sponsors have concerns
  • upon termination of the clinical site
  • to provide real-time assessment of the investigator’s conduct of the trial and protection of human subjects during an ongoing trial
  • at the request of an FDA review division
  • for trials that are being conducted on investigational products that have been identified as a product of special interest

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