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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Clinical Study Operations | 15% | - Site management
|
| Topic 2: Professionalism and Ethical Practice | 15% | - Professional standards
|
| Topic 3: Regulatory and Compliance Requirements | 17% | - ICH Guidelines
|
| Topic 4: Ethical and Participant Safety Considerations | 19% | - Clinical care and management of research participants
|
| Topic 5: Data Management and Informatics | 17% | - Data quality control
|
| Topic 6: Study Design and Conduct | 17% | - Study implementation
|
ACRP Certified Professional Sample Questions:
1. A study sponsor approaches a facility about participating in their research study. The study sponsor requires use of social media as its sole method of recruitment. The site knows their institutional IRB/IEC does not approve of social media recruiting. How should the site respond?
A) Rely on the sponsor to notify the IRB/IEC.
B) Recruit for the study without use of social media.
C) Decline the study.
D) Use a central IRB/IEC.
2. The sponsor should supply a PI with the IP after:
A) Approval of protocol by the sponsor.
B) Approval/favorable opinion from IRB/IEC and regulatory authority.
C) Submission of documents to IRB/IEC and regulatory authority for review.
D) Approval of protocol by the PI.
3. A clinical trial where participants will be randomized to receive a sequence of two medications has which design configuration?
A) Crossover
B) Factorial
C) Group sequential
D) Parallel Group
4. An interim analysis is conducted during a clinical trial. To review the results, the sponsor assigns:
A) Investigators participating in the trial.
B) Regulatory authority expert advisors.
C) Independent qualified individuals.
D) Executive board members.
5. Which of the following statements accurately describes the responsibilities of stakeholders involved in the conduct of a clinical study?
A) The regulatory authority is responsible for assessing and approving the clinical study protocol and accompanying CRF prior to implementation.
B) The IRB/IEC is responsible for obtaining consent from all subjects in the clinical study.
C) The CRC is responsible for identifying the relationship of an SAE to the IP.
D) The sponsor is responsible for overseeing any delegated activities to a CRO and ensuring that the delegation of these activities is documented.
Solutions:
| Question # 1 Answer: C | Question # 2 Answer: B | Question # 3 Answer: A | Question # 4 Answer: C | Question # 5 Answer: D |




