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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Study Design and Conduct | 17% | - Study implementation
|
| Topic 2: Regulatory and Compliance Requirements | 17% | - International standards
|
| Topic 3: Clinical Study Operations | 15% | - Project management
|
| Topic 4: Professionalism and Ethical Practice | 15% | - Professional standards
|
| Topic 5: Data Management and Informatics | 17% | - Data collection
|
| Topic 6: Ethical and Participant Safety Considerations | 19% | - Ethical principles
|
ACRP Certified Professional Sample Questions:
1. Which of the following should be considered when implementing a risk-based monitoring plan?
A) 100% source document review is mandatory.
B) On-site monitoring frequency may change depending on the quality of the data.
C) Centralized monitoring must be incorporated in any trials.
D) Monitoring schedule must be pre-defined in the monitoring plan.
2. Access to study documentation for auditors and inspectors during an audit or inspection at a clinical trial site is the responsibility of the:
A) CRA
B) CRC
C) Sponsor
D) PI
3. In preparation for an upcoming site audit, whose responsibility is it to ensure study-related functions were conducted by qualified personnel?
A) CRA
B) CRC
C) Investigator
D) Sponsor
4. During a mid-study sponsor audit of a clinical trial, the auditor notices that all of the protocol-required subject drug dosing diaries were incomplete. The effect of this will be the inability to:
A) Evaluate study data.
B) Validate protocol endpoints.
C) Verify compliance with IP regimen.
D) Conduct safety analysis.
5. The site submitted all start-up documents for a study to the sponsor and the IRB/IEC. The site also has subjects identified for screening. What should happen FIRST?
A) Obtain IRB/IEC approval
B) Ship/receive IP
C) Verify subject eligibility
D) Schedule a site initiation visit
Solutions:
| Question # 1 Answer: B | Question # 2 Answer: D | Question # 3 Answer: C | Question # 4 Answer: C | Question # 5 Answer: A |
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