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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. Per protocol, participants are scheduled to receive IP, which is calculated based on the participant's current weight. Unknown to the pharmacist, a participant recently lost 15 pounds and was overdosed as a result. What is the FIRST action the CRC must take to ensure the participant's safety?

A) Notify the PI.
B) Call the participant to return for an unscheduled visit.
C) Notify the sponsor.
D) Report a protocol deviation to the IRB/IEC.

2. In preparation for an upcoming site audit, whose responsibility is it to ensure study-related functions were conducted by qualified personnel?

A) CRC
B) CRA
C) Investigator
D) Sponsor

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

4. 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.

5. An audit was recently completed and identified non-compliance that could potentially affect the reliability of study results. Who should perform a root cause analysis and implement appropriatecorrective and preventive actions?

A) Sponsor
B) IRB/IEC
C) PI
D) DSMB/IDMC

Solutions: