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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Data Management and Informatics | 17% | - Data reporting
|
| Study Design and Conduct | 17% | - Study implementation
|
| Clinical Study Operations | 15% | - Project management
|
| Ethical and Participant Safety Considerations | 19% | - Clinical care and management of research participants
|
| Professionalism and Ethical Practice | 15% | - Professional standards
|
| Regulatory and Compliance Requirements | 17% | - Compliance procedures
|
ACRP Certified Professional Sample Questions:
Who determines what criteria and procedures should be followed if a subject discontinues/withdraws their consent?
- A. Sponsor
- B. CRO
- C. Subject
- D. PI
Correct Answer: A 🗳️
Explanation: Only visible for ActualVCE members. You can sign-up / login (it's free).
Which statement does NOT represent a study monitor's responsibilities?
- A. Provide communication between the sponsor and the PI.
- B. Verify that the PI has adequate qualifications and resources to conduct the study.
- C. Check the accuracy and completeness of case report forms with source documents.
- D. Report serious adverse events to the IRB/IEC.
Correct Answer: D 🗳️
Explanation: Only visible for ActualVCE members. You can sign-up / login (it's free).
Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of the following documents?
- A. Protocol, informed consent, and clinical trial agreement
- B. IB, site coordinator CVs, and information about payments and compensation available to subjects
- C. Protocol, site coordinator CVs, and clinical trial agreement
- D. Protocol, IB, and information about payments and compensation available to subjects
Correct Answer: D 🗳️
Explanation: Only visible for ActualVCE members. You can sign-up / login (it's free).
A sponsor writes a protocol comparing an IP XYZ to a marketed drug ABC to determine if XYZ is more efficacious in the target population than ABC. Both drugs are prepared in identically masked IV bags and distributed according to the randomization scheme outlined in the protocol such that the study team is unaware of the treatment assignment.
Which of the following is an appropriate title for this study?
- A. A randomized, double-blind, double-dummy, superiority study comparing the efficacy of XYZ to ABC in the target population
- B. A randomized, double-blind, superiority study comparing the efficacy of XYZ to ABC in the target population
- C. A randomized, single-blind, placebo-controlled study comparing the efficacy of XYZ to ABC in the target population
- D. A randomized, open-label, comparator study comparing the efficacy of XYZ to ABC in the target population
Correct Answer: B 🗳️
Explanation: Only visible for ActualVCE members. You can sign-up / login (it's free).
All site financial matters pertaining to a trial are listed in what document?
- A. Protocol
- B. Informed consent form
- C. Financial disclosure
- D. Signed contract
Correct Answer: D 🗳️
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