SOCRA CCRP Practice Exam

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Master the SOCRA CCRP Exam with our comprehensive practice quiz. Tailored feedback, detailed explanations, and real-world scenarios to boost your confidence and success.

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What does the FDA regulation require regarding investigator's provision of access to records for audits?

Investigators must always divulge subject names
Investigators shall permit FDA to access, copy, and verify records
Investigators must provide access to financial records
Investigators shall only provide summaries of patient records

The correct answer is: Investigators shall permit FDA to access, copy, and verify records

FDA regulation requires investigators to permit the FDA to have access, make copies, and verify records during audits. This is important for ensuring compliance and safety standards are being followed. Option A is incorrect because the FDA does not require investigators to divulge subject names unless necessary for the audit. Option C is incorrect because the FDA only requires access to records related to the conduct of the clinical trial, not financial records. Option D is incorrect because the FDA requires full access to patient records, not just summaries.