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Exam Code: ACRP-CP
Exam Name: ACRP Certified Professional Exam
Certification Provider: ACRP
Corresponding Certification: ACRP Certified Professional

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ACRP-CP

Last Updated: Oct 05, 2026

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ACRP ACRP-CP Exam Syllabus Topics:

SectionWeightObjectives
Topic 1: Regulatory and Compliance Requirements17%- Compliance procedures
  • 1. Regulatory submissions and approvals
  • 2. Audits and inspections
- International standards
  • 1. Declaration of Helsinki
- ICH Guidelines
  • 1. E2A Expedited Reporting
  • 2. E9 Statistical Principles
  • 3. E11 Pediatric Trials
  • 4. E8 General Considerations for Clinical Trials
  • 5. E6(R2)/E6(R3) Good Clinical Practice
Topic 2: Data Management and Informatics17%- Data reporting
  • 1. Database lock and data transfer
  • 2. Data integrity and security
- Data quality control
  • 1. Data validation and cleaning
  • 2. Query management and resolution
- Data collection
  • 1. Case report form design and completion
  • 2. Electronic data capture systems
Topic 3: Study Design and Conduct17%- Study planning
  • 1. Sample size and statistical considerations
  • 2. Protocol development and amendments
  • 3. Study population and eligibility criteria
- Study implementation
  • 1. Investigational product management
  • 2. Study monitoring and oversight
  • 3. Site selection and activation
Topic 4: Professionalism and Ethical Practice15%- Continuous improvement
  • 1. Quality assurance and process improvement
  • 2. Professional development and education
- Professional standards
  • 1. Confidentiality and conflict of interest
  • 2. Role responsibilities and boundaries
Topic 5: Ethical and Participant Safety Considerations19%- Safety monitoring and reporting
  • 1. Safety information evaluation and communication
  • 2. Adverse event identification and classification
- Clinical care and management of research participants
  • 1. Standard of care vs protocol requirements
  • 2. Continuity of medical care
  • 3. Informed consent development and review
- Ethical principles
  • 1. Clinical equipoise and therapeutic misconception
  • 2. Human subject protections and privacy
Topic 6: Clinical Study Operations15%- Site management
  • 1. Site personnel training and delegation
  • 2. Study documentation and record keeping
- Project management
  • 1. Vendor and stakeholder management
  • 2. Timeline and budget management

ACRP Certified Professional Sample Questions:

Question #1

A sponsor wants a new clinical trial to be reviewed at regular intervals for progress, safety, and endpoint evaluation, and make recommendations to continue, modify, or stop the trial. How should they proceed?

  • A. Draft a CAPA plan
  • B. Establish a DSMB/IDMC
  • C. Develop a monitoring plan
  • D. Conduct routine investigators' meetings
Reveal Solution  Discussion  0

Correct Answer: B  🗳️

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Question #2

A deferred consent can take place in which of the following situations?

  • A. Only when the PI approves such a consent process immediately prior to patient enrollment, regardless of the situation being classed as emergency.
  • B. In an emergency situation only, even when this process is not described in the protocol, but the sponsor approves the consent process.
  • C. Only when the PI approves such a consent process, regardless of the emergency situation described in the protocol.
  • D. In an emergency situation only, when this process is described in the protocol and has received permission from the ethics committee.
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Correct Answer: D  🗳️

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Question #3

One key attribute for good study documentation is that the data are contemporaneous, which refers to the practice of:

  • A. Allowing real-time access for data review in the eCRF.
  • B. Recording the date and time each data element is entered onto the source document.
  • C. Comparing source document data to other data recorded in the same study time period.
  • D. Recording data on source documents at the time the data are collected during the conduct of the study.
Reveal Solution  Discussion  0

Correct Answer: D  🗳️

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Question #4

An audit was recently completed and identified non-compliance that could potentially affect the reliability of study results. Who should perform a root cause analysis and implement appropriatecorrective and preventive actions?

  • A. IRB/IEC
  • B. Sponsor
  • C. PI
  • D. DSMB/IDMC
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Correct Answer: C  🗳️

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Question #5

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. Immediately unblind the entire trial to ensure patient safety.
  • 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. Request the DSMB to conduct a full risk assessment and recommend whether the sub-group should be unblinded.
Reveal Solution  Discussion  0

Correct Answer: D  🗳️

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