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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Data and Quality Management | - Quality assurance and quality control - Clinical data management principles |
| Clinical Research Foundations | - Ethical conduct in clinical trials - Good Clinical Practice (GCP) principles |
| Study Operations | - Study conduct and oversight - Study planning and initiation |
| Participant Safety and Protection | - Safety reporting and adverse events - Informed consent process |
| Regulatory Compliance | - Regulatory documentation and submissions - Audit and inspection readiness |
ACRP Certified Professional Sample Questions:
1. Confidentiality and privacy rules for protection of human subjects at research sites are determined by the:
A) Applicable regulatory authorities
B) Sponsor
C) Applicable site SOPs
D) PI
2. Who is responsible for securing agreement from all involved parties to ensure direct access of all trial-related source documents?
A) Sponsor
B) CRC
C) CRO
D) Investigator
3. A potential subject is interested in a new clinical trial and would like to learn more about the risks and benefits of participation. Where can they find this information?
A) ICF
B) IB
C) Protocol
D) Package insert
4. In a quality management system, in which category do risk reduction activities belong?
A) Risk Evaluation
B) Risk Control
C) Risk Communication
D) Risk Review
5. 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 sponsor.
B) Report a protocol deviation to the IRB/IEC.
C) Call the participant to return for an unscheduled visit.
D) Notify the PI.
Solutions:
| Question # 1 Answer: A | Question # 2 Answer: A | Question # 3 Answer: A | Question # 4 Answer: B | Question # 5 Answer: D |
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