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ACRP Certified Professional Sample Questions:

1. In addition to members who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial, it is recommended that the IRB/IEC should include:

A) One member who is independent of the institution/trial site.
B) One member of the site's QA group.
C) A total of five members.
D) One member whose primary area of interest is in the same scientific area.

2. The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?

A) Regulatory Agency
B) Sponsor
C) PI
D) CRC

3. An investigator participating in a multicenter clinical trial has had 2 of the 4 subjects admitted to the emergency room for life-threatening infections. The investigator made the decision to stop treatment with IP and test for infections in the remaining subjects. What are the NEXT steps the investigator should take?

A) Add the risk of infection to the ICF and submit to the IRB/IEC for review.
B) Notify the sponsor of the change in study plan and submit the deviation to the IRB/IEC for review.
C) Discontinue current subjects from the study and monitor subjects for any anticipated safety events.
D) Update the IB to add the risk of infection and submit to the sponsor for approval.

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

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

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

Solutions: