SOCRA CCRP Practice Exam

What are the components of an FDA audit?

1. Initial meeting, inspection, review of financials, and final report

2. Notice of inspection, opening interview, records inventory and audit, documentation of findings, close-out discussion

3. Review of protocols, inspection of sites, interviews with staff, and a compliance certificate

4. Submission of trial data, inspection of lab equipment, and a safety review

The correct answer is: Notice of inspection, opening interview, records inventory and audit, documentation of findings, close-out discussion

Possible explanationAn FDA audit typically includes an initial meeting between the auditors and the company being audited, where the audit process is discussed. This is followed by a notice of inspection, where the auditors inform the company of the date and time of the actual audit. During the opening interview, the auditors may discuss the company's procedures and protocols. A records inventory and audit is then conducted, where the auditors review the company's documentation and records. The auditors then document their findings and have a close-out discussion with the company to discuss any issues or concerns. Option A is incorrect because it does not include a records inventory and audit, which is an important component of an FDA audit. Option C is incorrect as it only mentions a review of protocols and interviews with staff, but does not mention the notice of inspection or close-out discussion. Option D is incorrect as it only mentions