ACRP ACRP-CP : ACRP Certified Professional Exam

  • Exam Code: ACRP-CP
  • Exam Name: ACRP Certified Professional Exam
  • Updated: Sep 28, 2026
  • Q & A: 127 Questions and Answers

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ACRP ACRP-CP Exam Syllabus Topics:

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

ACRP Certified Professional Sample Questions:

Question #1

Who is responsible for defining, establishing, and allocating all trial-related duties and functions prior to initiating a trial?

  • A. CRO
  • B. Investigator
  • C. IRB/IEC
  • D. Sponsor
Reveal Solution  Discussion  0

Correct Answer: D  🗳️

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Question #2

Per protocol, participants are scheduled to receive IP, which is calculated based on the participant's current weight. Unknown to the pharmacist, a participant recently lost 15 pounds and was overdosed as a result. What is the FIRST action the CRC must take to ensure the participant's safety?

  • A. Report a protocol deviation to the IRB/IEC.
  • B. Notify the sponsor.
  • C. Call the participant to return for an unscheduled visit.
  • D. Notify the PI.
Reveal Solution  Discussion  0

Correct Answer: D  🗳️

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Question #3

Who determines what criteria and procedures should be followed if a subject discontinues/withdraws their consent?

  • A. CRO
  • B. Subject
  • C. PI
  • D. Sponsor
Reveal Solution  Discussion  0

Correct Answer: D  🗳️

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Question #4

A protocol requires participants to take IP for 6 months. The protocol allows for any participants who are noncompliant to be replaced by enrolling additional participants, except if it is due to an AE. The investigator has enrolled 12 participants.
The status of the enrolled participants is as follows:
* 3 participants were withdrawn due to noncompliance
* 1 participant withdrew consent after experiencing severe nausea
* 1 participant had to discontinue IP for an unscheduled hospitalization
* 1 participant who is not returning for visits
* 2 participants completed the 6 months of treatment
* 4 participants currently on IP
How many participants should be replaced?

  • A. 3 participants
  • B. 5 participants
  • C. 6 participants
  • D. 4 participants
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

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Question #5

A root cause analysis should be:

  • A. Specific to a clinical trial.
  • B. Focused on issues of non-compliance.
  • C. Written by the investigator.
  • D. Validated before use in a CAPA.
Reveal Solution  Discussion  0

Correct Answer: B  🗳️

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