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Are FDA inspections of clinical investigator sites announced or unannounced?

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Proxima CRO Team
Alisa Hamilton
Director of Operations
Alisa’s overall goal through everything she has achieved at Proxima is to make it one of the most enjoyable places to work. ‍

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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