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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Regulatory and Compliance Requirements | 17% | - Compliance procedures
|
| Clinical Study Operations | 15% | - Project management
|
| Data Management and Informatics | 17% | - Data reporting
|
| Ethical and Participant Safety Considerations | 19% | - Clinical care and management of research participants
|
| Professionalism and Ethical Practice | 15% | - Professional standards
|
| Study Design and Conduct | 17% | - Study planning
|
ACRP Certified Professional Sample Questions:
Access to study documentation for auditors and inspectors during an audit or inspection at a clinical trial site is the responsibility of the:
- A. PI
- B. CRA
- C. CRC
- D. Sponsor
Correct Answer: A 🗳️
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At a close-out visit, which document should be retained only at the site?
- A. Final trial close-out monitoring report
- B. Treatment allocation
- C. IP accountability
- D. Subject identification code list
Correct Answer: D 🗳️
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Per the protocol, participants' blood creatinine level must be no greater than 2.5 times the upper limit of normal (0.7-1.2 mg/dL). What is the maximum creatinine level the participant can have and be eligible for the trial?
- A. 2.6 mg/dL
- B. 3.0 mg/dL
- C. 3.6 mg/dL
- D. 1.8 mg/dL
Correct Answer: B 🗳️
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Which of the following statements accurately describes the responsibilities of stakeholders involved in the conduct of a clinical study?
- A. The CRC is responsible for identifying the relationship of an SAE to the IP.
- B. The IRB/IEC is responsible for obtaining consent from all subjects in the clinical study.
- C. The regulatory authority is responsible for assessing and approving the clinical study protocol and accompanying CRF prior to implementation.
- D. The sponsor is responsible for overseeing any delegated activities to a CRO and ensuring that the delegation of these activities is documented.
Correct Answer: D 🗳️
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When designing a clinical trial, why is it important to define the study population?
- A. To support subject recruitment to the study
- B. To support the study objectives
- C. To determine the study objectives
- D. To determine where to conduct the study
Correct Answer: B 🗳️
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