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ACRP ACRP-CP Exam Syllabus Topics:

Section	Objectives
Topic 1: Data Management and Documentation	- Clinical trial documentation 1. Source documentation 2. Essential documents - Data integrity 1. Data collection 2. Query resolution
Topic 2: Clinical Trial Operations	- Study start-up activities 1. Site preparation 2. Protocol implementation - Study conduct 1. Safety reporting 2. Participant management
Topic 3: Ethical and Participant Safety Considerations	- Regulatory compliance 1. ICH GCP adherence 2. IRB and ethics requirements - Human subject protection 1. Participant rights 2. Informed consent
Topic 4: Quality Management	- Risk management 1. Corrective and preventive actions 2. Quality assurance - Audit and inspection readiness 1. Inspection preparation 2. Compliance monitoring
Topic 5: Professional Responsibilities	- Leadership and professionalism 1. Professional ethics 2. Decision making - Communication and collaboration 1. Stakeholder communication 2. Cross-functional teamwork

ACRP Certified Professional Sample Questions:

Question #1

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

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

Reveal Solution Discussion 0

Correct Answer: A 🗳️

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Question #2

During a multi-center, double-blind, placebo-controlled Phase III clinical trial evaluating a novel oncology drug, the following situation occurs:
An interim analysis performed by the DSMB reveals that the investigational product (IP) shows a statistically significant improvement in progression-free survival (PFS) compared to the placebo. However, a sub-group analysis indicates a higher incidence of Grade 4 hepatotoxicity in patients with pre-existing mild liver dysfunction.
The sponsor, upon reviewing the DSMB report, decides to unblind the affected sub-group to assess safety.
The trial protocol specifies that unblinding should only occur if a life-threatening situation is identified.
What is the most appropriate next step the sponsor should take?

A. Request the DSMB to conduct a full risk assessment and recommend whether the sub-group should be unblinded.
B. Submit the DSMB findings to the IRB/IEC and await their guidance before proceeding.
C. Conduct an urgent protocol amendment to include specific monitoring for hepatotoxicity and submit to the IRB/IEC.
D. Immediately unblind the entire trial to ensure patient safety.

Reveal Solution Discussion 0

Correct Answer: A 🗳️

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Question #3

A study protocol must contain which of the following elements?