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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Data Management and Informatics | 17% | - Data quality control
|
| Clinical Study Operations | 15% | - Site management
|
| Regulatory and Compliance Requirements | 17% | - ICH Guidelines
|
| Ethical and Participant Safety Considerations | 19% | - Ethical principles
|
| Study Design and Conduct | 17% | - Study implementation
|
| Professionalism and Ethical Practice | 15% | - Professional standards
|
ACRP Certified Professional Sample Questions:
1. Which of the following is a conflict of interest for a PI conducting a study?
A) A PI that presents at an investigator meeting
B) A PI that votes on the IRB/IEC approval of the protocol
C) A PI who receives payment for the study
D) A PI who is a key opinion leader, writes the protocol
2. An investigator in a multicenter trial reports multiple occurrences of an SAE to the sponsor. Who is responsible for reporting the SAEs to the remaining sites' IRB/IECs?
A) Original reporting investigator
B) Investigator at each site
C) Regulatory authority
D) Study sponsor
3. Centralized monitoring can:
A) Enable appropriate stratification of subject enrollment.
B) Confirm why sites are deviating from the protocol.
C) Indicate the need to send monitors to perform onsite visits.
D) Identify IP accountability and storage issues.
4. The composition of an IDMC/DSMB should include which one of the following?
A) A lead PI for the study
B) A member from the IRB/IEC
C) A clinical scientist who is knowledgeable in the appropriate discipline
D) A sponsor representative who is knowledgeable about the study's unblinded information
5. What would a sponsor use to implement and maintain quality in a study?
A) Protocol signature pages
B) Standard operating procedures
C) Statistical analysis plan
D) Clinical trial agreement
Solutions:
| Question # 1 Answer: B | Question # 2 Answer: D | Question # 3 Answer: C | Question # 4 Answer: C | Question # 5 Answer: B |
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