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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Ethical and Participant Safety Considerations | 19% | - Safety monitoring and reporting
|
| Clinical Study Operations | 15% | - Site management
|
| Professionalism and Ethical Practice | 15% | - Professional standards
|
| Study Design and Conduct | 17% | - Study planning
|
| Regulatory and Compliance Requirements | 17% | - ICH Guidelines
|
| Data Management and Informatics | 17% | - Data collection
|
ACRP Certified Professional Sample Questions:
1. In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?
A) Randomization
B) Placebo-controlled
C) Privacy controls
D) Blinding
2. The coding system for a double-blind clinical trial is accessible by the:
A) Regulatory authority
B) Sponsor
C) IRB/IEC
D) PI
3. When designing a clinical trial, why is it important to define the study population?
A) To support the study objectives
B) To support subject recruitment to the study
C) To determine the study objectives
D) To determine where to conduct the study
4. After the site qualification visit report has been finalized, it must be:
A) Sent to the IRB/IEC for review and approval.
B) Stored in the sponsor's budgets and contracts file.
C) Included in the PI's regulatory file.
D) Kept in the CRO/sponsor's trial master file.
5. Which strategy is used to safeguard subject privacy?
A) Utilize subject initials on correspondence.
B) Email updated enrollment logs to the CRA.
C) Store source documentation in the CRC's office.
D) Conduct subject-related conversations in controlled environments.
Solutions:
| Question # 1 Answer: A | Question # 2 Answer: B | Question # 3 Answer: A | Question # 4 Answer: D | Question # 5 Answer: D |

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