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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Ethical and Participant Safety Considerations | 19% | - Ethical principles
|
| Topic 2: Professionalism and Ethical Practice | 15% | - Continuous improvement
|
| Topic 3: Clinical Study Operations | 15% | - Site management
|
| Topic 4: Study Design and Conduct | 17% | - Study implementation
|
| Topic 5: Data Management and Informatics | 17% | - Data collection
|
| Topic 6: Regulatory and Compliance Requirements | 17% | - International standards
|
ACRP Certified Professional Sample Questions:
1. Which of the following elements of the Informed Consent are NOT required?
A) Statement that study involves research
B) A description of potential benefits
C) A description of any reasonably foreseeable risks or discomforts
D) Subject legal rights can be waived
2. After the completion or termination of a clinical trial, who should store the enrollment log?
A) PI
B) Regulatory authority
C) CRO
D) Sponsor
3. In preparation for an upcoming site audit, whose responsibility is it to ensure study-related functions were conducted by qualified personnel?
A) CRC
B) Investigator
C) CRA
D) Sponsor
4. After the site qualification visit report has been finalized, it must be:
A) Stored in the sponsor's budgets and contracts file.
B) Included in the PI's regulatory file.
C) Sent to the IRB/IEC for review and approval.
D) Kept in the CRO/sponsor's trial master file.
5. Which one of the following is a primary objective of a Phase III study of a new IP?
A) To establish dose information
B) To demonstrate or confirm therapeutic benefit
C) To show superiority over another treatment
D) To establish the safety profile
Solutions:
| Question # 1 Answer: D | Question # 2 Answer: A | Question # 3 Answer: B | Question # 4 Answer: D | Question # 5 Answer: B |
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