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ACRP ACRP-CP Exam Syllabus Topics:

SectionObjectives
Data Management and Documentation- Clinical trial documentation
  • 1. Essential documents
  • 2. Source documentation
- Data integrity
  • 1. Data collection
  • 2. Query resolution
Clinical Trial Operations- Study start-up activities
  • 1. Site preparation
  • 2. Protocol implementation
- Study conduct
  • 1. Safety reporting
  • 2. Participant management
Professional Responsibilities- Communication and collaboration
  • 1. Cross-functional teamwork
  • 2. Stakeholder communication
- Leadership and professionalism
  • 1. Professional ethics
  • 2. Decision making
Ethical and Participant Safety Considerations- Regulatory compliance
  • 1. IRB and ethics requirements
  • 2. ICH GCP adherence
- Human subject protection
  • 1. Informed consent
  • 2. Participant rights
Quality Management- Audit and inspection readiness
  • 1. Inspection preparation
  • 2. Compliance monitoring
- Risk management
  • 1. Corrective and preventive actions
  • 2. Quality assurance

ACRP Certified Professional Sample Questions:

Question 1

When designing a clinical trial, why is it important to define the study population?

A. To support the study objectives
B. To determine where to conduct the study
C. To determine the study objectives
D. To support subject recruitment to the study


Question 2

A study drug will be shipped, stored, and mixed at the hospital pharmacy and will be transferred to the study site for infusion. Which document describes how the transfer will occur?

A. Standard Operating Procedure
B. Clinical Monitoring Plan
C. Investigator's Brochure
D. Data & Safety Monitoring Plan


Question 3

A PI is being considered for an industry-sponsored study. The PI sees approximately 20 patients per month who meet the study criteria. The PI does not have access to a Positron Emission Tomography (PET) scanner, which is required for the protocol. The PI is already taking part in three other studies. Should the Sponsor choose this PI?

A. No, the PI does not have the resources to perform all protocol-required procedures.
B. Yes, the PI can perform other imaging scans instead of the PET scans.
C. No, the PI is taking part in too many ongoing studies to participate in this study.
D. Yes, the PI has a sufficient patient population to take part in this study.


Question 4

Which of the following should be considered when implementing a risk-based monitoring plan?

A. 100% source document review is mandatory.
B. Centralized monitoring must be incorporated in any trials.
C. On-site monitoring frequency may change depending on the quality of the data.
D. Monitoring schedule must be pre-defined in the monitoring plan.


Question 5

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. Use a central IRB/IEC.
B. Recruit for the study without use of social media.
C. Rely on the sponsor to notify the IRB/IEC.
D. Decline the study.


Solutions:

Question 1
Answer: A
Question 2
Answer: A
Question 3
Answer: A
Question 4
Answer: C
Question 5
Answer: D

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