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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Ethical and Participant Safety Considerations | - Regulatory compliance
|
| Topic 2: Quality Management | - Audit and inspection readiness
|
| Topic 3: Data Management and Documentation | - Data integrity
|
| Topic 4: Clinical Trial Operations | - Study conduct
|
| Topic 5: Professional Responsibilities | - Communication and collaboration
|
ACRP Certified Professional Sample Questions:
1. The PI may assign responsibility for IP accountability to the pharmacist provided they are:
A) Approved by the IRB/IEC.
B) An employee of the institution.
C) Under the supervision of the PI.
D) Licensed to practice medicine.
2. Which entity has ultimate responsibility over the conduct of the multi-center clinical trial?
A) Regulatory authority
B) CRO
C) IRB/IEC
D) Sponsor-Investigator
3. An interim analysis is conducted during a clinical trial. To review the results, the sponsor assigns:
A) Regulatory authority expert advisors.
B) Investigators participating in the trial.
C) Independent qualified individuals.
D) Executive board members.
4. The coding system for a double-blind clinical trial is accessible by the:
A) Regulatory authority
B) IRB/IEC
C) PI
D) Sponsor
5. 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) A total of five members.
B) One member who is independent of the institution/trial site.
C) One member of the site's QA group.
D) One member whose primary area of interest is in the same scientific area.
Solutions:
| Question # 1 Answer: C | Question # 2 Answer: D | Question # 3 Answer: C | Question # 4 Answer: D | Question # 5 Answer: B |
