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ACRP Certified Professional Sample Questions:

1. After the site qualification visit report has been finalized, it must be:

A) Stored in the sponsor's budgets and contracts file.
B) Included in the PI's regulatory file.
C) Sent to the IRB/IEC for review and approval.
D) Kept in the CRO/sponsor's trial master file.

2. The coding system for a double-blind clinical trial is accessible by the:

A) Regulatory authority
B) IRB/IEC
C) Sponsor
D) PI

3. 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 the following should the site personnel do next?

A) Allow access to the entire records.
B) Deny the request until the sponsor approves.
C) Consult with the IRB/IEC first.
D) Redact subject identification for privacy protection.

4. A clinical trial where participants will be randomized to receive a sequence of two medications has which design configuration?

A) Parallel Group
B) Group sequential
C) Crossover
D) Factorial

5. Which of the following activities is the MOST efficient way of overseeing a CRO's management during a clinical trial?

A) Central monitoring of data fields by sponsor
B) Co-monitoring of CRO site visits
C) Risk-based audits of CRO activities as delegated
D) Pre-qualification assessment of CRO

Solutions: