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fda audit clinical trials

Running a Site 6 Minute Read

Our Clinical Research Site Went Through an FDA Audit

Dr. James Clark of Charlottesville Medical Research recently had an FDA inspection of his site as it is a high enroller. He did not receive a FDA Form 483, and he was using the CRIO electronic source system on the study. Learn about his experience in this Q&A session. CRIO: What’s your background? Dr. Clark:...

Running a Site
5 Minute Read -

The 5 Stages of an FDA Audit for Clinical Trial Sites

Hear what it feels like to endure an FDA audit as a Principal Investigator or clinical research site owner, based on interviews with current or former site owners and operators. Stage 1 of an FDA Audit: Anticipation One mistake could ruin your clinical trial site… Unfortunately, many site owners and principal investigators live in constant...

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