Audits

You just received a phone call from the FDA. They want to inspect your site as soon as it is convenient for you. post a comprehensive response to the following:
• What are some of the reasons why the FDA might want to conduct an audit at your site? • How will you prepare for their visit? • How would your preparation differ for a site audit by the study sponsor? • How would your preparation differ for a site audit by the IRB?
The FDA has now completed its audit of your site, and you are awaiting the findings.
• What are the categories of response that might come from the FDA? What are the consequences that your site or the principal investigator might face if problems were identified during the audit?

 

Sample Solution

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