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Question # 1
After the site qualification visit report has been finalized, it must be:
A. Kept in the CRO/sponsor's trial master file.
B. Included in the PI's regulatory file.
C. Stored in the sponsor's budgets and contracts file.
D. Sent to the IRB/IEC for review and approval.
Question # 2
A representative from a regulatory authority shows up unannounced at a research site.After confirming their credentials, the representative requested to view the entire records,including identifiable information, from study XYZ that was closed out. Which of thefollowing should the site personnel do next?
A. Redact subject identification for privacy protection.
B. Deny the request until the sponsor approves.
C. Allow access to the entire records.
D. Consult with the IRB/IEC first.
Question # 3
AEs that occur between study visits of a clinical trial should be evaluated by the:
A. Subject's primary care physician
B. Principal Investigator
C. Medical monitor
D. Study pharmacovigilance physician
Question # 4
Who must be blinded in a double-blind study in order to prevent bias?
A. Pharmacist
B. Subject
C. Data entry staff
D. IRB/IEC
Question # 5
A study subject inadvertently disposed of IP medication bottles. The site should report thisto the:
A. Sponsor.
B. IRB/IEC.
C. Medical monitor.
D. Regulatory authority.
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