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ACRP ACRP-CP Exam Syllabus Topics:

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

ACRP Certified Professional Sample Questions:

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. 1.8 mg/dL
  • B. 3.6 mg/dL
  • C. 3.0 mg/dL
  • D. 2.6 mg/dL
Reveal Solution  Discussion  0

Correct Answer: C  🗳️

Explanation: Only visible for ExamPrepAway members. You can sign-up / login (it's free).

IP is dispensed to all subjects who:

  • A. Need IP for their medical condition.
  • B. Are eligible to receive it in the trial.
  • C. Consented for the trial.
  • D. Screened for the trial.
Reveal Solution  Discussion  0

Correct Answer: B  🗳️

Explanation: Only visible for ExamPrepAway members. You can sign-up / login (it's free).

Source data/documentation should be:

  • A. Attributable, legible, contemporaneous, original, accurate, and complete.
  • B. Attributable, legible, contemporaneous, original, accurate, and clear.
  • C. Attributable, legible, correct, original, accurate, and clear.
  • D. Attributable, legible, correct, original, accurate, and complete.
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

Explanation: Only visible for ExamPrepAway members. You can sign-up / login (it's free).

The PI did not record the relationship to IP in the medical chart when assessing an adverse event. The CRC noticed the omission and brought it to the PI's attention. How should this be addressed?

  • A. The PI should notify the monitor.
  • B. The PI should amend the medical chart.
  • C. The CRC should amend the medical chart.
  • D. The CRC should write a note to file.
Reveal Solution  Discussion  0

Correct Answer: B  🗳️

Explanation: Only visible for ExamPrepAway members. You can sign-up / login (it's free).

A printed, optical, or electronic document designed to record all of the protocol-required information and is transmitted to the sponsor is called a:

  • A. Worksheet.
  • B. Source document.
  • C. CRF.
  • D. PRO.
Reveal Solution  Discussion  0

Correct Answer: C  🗳️

Explanation: Only visible for ExamPrepAway members. You can sign-up / login (it's free).

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