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FRequently Asked Questions
Are FDA inspections of clinical investigator sites announced or unannounced?
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About the Author
Alisa Survance
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.
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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
Related Terms:
Investigator
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What is a consent agreement?
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What happens after the FDA inspects a clinical investigator?
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