ACRP ACRP-CP - ACRP Certified Professional Exam
- Exam Code: ACRP-CP
- Exam Name: ACRP Certified Professional Exam
- Updated: Aug 16, 2026
- Q & A: 127 Questions and Answers
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| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Clinical Study Operations | 15% | - Project management
|
| Topic 2: Professionalism and Ethical Practice | 15% | - Professional standards
|
| Topic 3: Data Management and Informatics | 17% | - Data reporting
|
| Topic 4: Ethical and Participant Safety Considerations | 19% | - Ethical principles
|
| Topic 5: Study Design and Conduct | 17% | - Study implementation
|
| Topic 6: Regulatory and Compliance Requirements | 17% | - ICH Guidelines
|
1. Who must be blinded in a double-blind study in order to prevent bias?
A) Pharmacist
B) IRB/IEC
C) Subject
D) Data entry staff
2. A protocol requires participants to take IP for 6 months. The protocol allows for any participants who are noncompliant to be replaced by enrolling additional participants, except if it is due to an AE. The investigator has enrolled 12 participants.
The status of the enrolled participants is as follows:
* 3 participants were withdrawn due to noncompliance
* 1 participant withdrew consent after experiencing severe nausea
* 1 participant had to discontinue IP for an unscheduled hospitalization
* 1 participant who is not returning for visits
* 2 participants completed the 6 months of treatment
* 4 participants currently on IP
How many participants should be replaced?
A) 5 participants
B) 3 participants
C) 4 participants
D) 6 participants
3. The sponsor should supply a PI with the IP after:
A) Approval/favorable opinion from IRB/IEC and regulatory authority.
B) Submission of documents to IRB/IEC and regulatory authority for review.
C) Approval of protocol by the sponsor.
D) Approval of protocol by the PI.
4. The primary purpose for IRB/IEC approval of posters, fliers, social media posts, and promotional items is to:
A) Review the content for ethically or morally sensitive issues.
B) Safeguard the rights, safety, and well-being of all potential subjects.
C) Assure the ads do not impinge on confidentiality agreements.
D) Confirm subjects receive the appropriate reimbursement.
5. Upon receiving their first dose of study drug in the clinic, the subject exhibits an immediately life-threatening reaction. The protocol prohibits any concomitant medications. What should be the investigator's IMMEDIATE response?
A) Administer rescue medication.
B) Call the medical monitor.
C) Consult the IB.
D) Report the AE to the sponsor.
Solutions:
| Question # 1 Answer: C | Question # 2 Answer: B | Question # 3 Answer: A | Question # 4 Answer: B | Question # 5 Answer: A |
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