- Exam Code: ACRP-CP
- Exam Name: ACRP Certified Professional Exam
- Updated: Aug 08, 2026
- Q & A: 127 Questions and Answers
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| Section | Objectives |
|---|---|
| Topic 1: Clinical Research Foundations | - Ethical conduct in clinical trials - Good Clinical Practice (GCP) principles |
| Topic 2: Participant Safety and Protection | - Safety reporting and adverse events - Informed consent process |
| Topic 3: Study Operations | - Study planning and initiation - Study conduct and oversight |
| Topic 4: Regulatory Compliance | - Regulatory documentation and submissions - Audit and inspection readiness |
| Topic 5: Data and Quality Management | - Quality assurance and quality control - Clinical data management principles |
1. When assessing the monitoring needs for a study, sponsors should:
A) Use central monitoring instead of conducting physical monitoring visits at sites.
B) Permit PIs to select a monitor for their site as long as they are independent of the PI.
C) Ensure monitoring visits are conducted at periodic intervals with a minimum of monthly monitoring visits.
D) Ensure monitors have the scientific and/or clinical knowledge needed to monitor the trial adequately.
2. Upon receipt of temperature-controlled IP, the study staff noticed the IP incurred a temperature excursion during transport. What should the staff do NEXT?
A) Quarantine IP without registering in IWRS and request replacement from sponsor.
B) Register IP in IWRS, quarantine and notify sponsor of the excursion.
C) Dispose of IP and request replacement from sponsor.
D) Register IP in IWRS and continue with subject allocation.
3. SAEs must be reported immediately by the site to the:
A) IRB/IEC.
B) Sponsor.
C) Regulatory agency.
D) DSMB/IDMC.
4. 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) Study sponsor
D) Regulatory authority
5. All of the following are examples of what monitors review EXCEPT:
A) Potential patient medical records for eligibility prior to the informed consent process.
B) The signed ICF retained in the participant's study file.
C) Documentation in the participant's medical record of study drug administration.
D) Regulatory binder which includes copies of current certifications for all laboratories.
Solutions:
| Question # 1 Answer: D | Question # 2 Answer: B | Question # 3 Answer: B | Question # 4 Answer: C | Question # 5 Answer: A |
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