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ACRP ACRP-CP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Study Design and Conduct | 17% | - Study planning
|
| Data Management and Informatics | 17% | - Data collection
|
| Professionalism and Ethical Practice | 15% | - Professional standards
|
| Regulatory and Compliance Requirements | 17% | - Compliance procedures
|
| Clinical Study Operations | 15% | - Project management
|
| Ethical and Participant Safety Considerations | 19% | - Clinical care and management of research participants
|
ACRP Certified Professional Sample Questions:
Question 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.
Question 2
A sponsor wants to transfer duties to a CRO. Which of the following statements is the MOST correct?
A. The IRB/IEC must approve the transfer of duties to a CRO.
B. Regulatory authorities must be notified promptly of the transfer of any duties to a CRO.
C. All duties transferred to a CRO should be specified in writing.
D. Any trial-related duties can be documented as transferred by verbal agreement.
Question 3
What would a sponsor use to implement and maintain quality in a study?
A. Clinical trial agreement
B. Protocol signature pages
C. Statistical analysis plan
D. Standard operating procedures
Question 4
Which of the following activities is the MOST efficient way of overseeing a CRO's management during a clinical trial?
A. Pre-qualification assessment of CRO
B. Central monitoring of data fields by sponsor
C. Risk-based audits of CRO activities as delegated
D. Co-monitoring of CRO site visits
Question 5
One key attribute for good study documentation is that the data are contemporaneous, which refers to the practice of:
A. Recording the date and time each data element is entered onto the source document.
B. Recording data on source documents at the time the data are collected during the conduct of the study.
C. Comparing source document data to other data recorded in the same study time period.
D. Allowing real-time access for data review in the eCRF.
Solutions:
| Question 1 Answer: C | Question 2 Answer: C | Question 3 Answer: D | Question 4 Answer: C | Question 5 Answer: B |


