ACRP ACRP-CP : ACRP Certified Professional Exam

  • Exam Code: ACRP-CP
  • Exam Name: ACRP Certified Professional Exam
  • Updated: Aug 08, 2026     Q & A: 127 Questions and Answers

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ACRP ACRP-CP Exam Syllabus Topics:

SectionWeightObjectives
Topic 1: 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
Topic 2: Professionalism and Ethical Practice15%- Professional standards
  • 1. Role responsibilities and boundaries
  • 2. Confidentiality and conflict of interest
- Continuous improvement
  • 1. Professional development and education
  • 2. Quality assurance and process improvement
Topic 3: Regulatory and Compliance Requirements17%- ICH Guidelines
  • 1. E9 Statistical Principles
  • 2. E11 Pediatric Trials
  • 3. E2A Expedited Reporting
  • 4. E8 General Considerations for Clinical Trials
  • 5. E6(R2)/E6(R3) Good Clinical Practice
- International standards
  • 1. Declaration of Helsinki
- Compliance procedures
  • 1. Regulatory submissions and approvals
  • 2. Audits and inspections
Topic 4: Ethical and Participant Safety Considerations19%- 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
- Safety monitoring and reporting
  • 1. Adverse event identification and classification
  • 2. Safety information evaluation and communication
Topic 5: Data Management and Informatics17%- 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
- Data reporting
  • 1. Data integrity and security
  • 2. Database lock and data transfer
Topic 6: Study Design and Conduct17%- Study implementation
  • 1. Study monitoring and oversight
  • 2. Investigational product management
  • 3. Site selection and activation
- Study planning
  • 1. Protocol development and amendments
  • 2. Sample size and statistical considerations
  • 3. Study population and eligibility criteria

ACRP Certified Professional Sample Questions:

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


2. The sponsor should supply a PI with the IP after:

A) Approval of protocol by the sponsor.
B) Approval/favorable opinion from IRB/IEC and regulatory authority.
C) Submission of documents to IRB/IEC and regulatory authority for review.
D) Approval of protocol by the PI.


3. A clinical trial where participants will be randomized to receive a sequence of two medications has which design configuration?

A) Crossover
B) Factorial
C) Group sequential
D) Parallel Group


4. An interim analysis is conducted during a clinical trial. To review the results, the sponsor assigns:

A) Investigators participating in the trial.
B) Regulatory authority expert advisors.
C) Independent qualified individuals.
D) Executive board members.


5. Which of the following statements accurately describes the responsibilities of stakeholders involved in the conduct of a clinical study?

A) The regulatory authority is responsible for assessing and approving the clinical study protocol and accompanying CRF prior to implementation.
B) The IRB/IEC is responsible for obtaining consent from all subjects in the clinical study.
C) The CRC is responsible for identifying the relationship of an SAE to the IP.
D) The sponsor is responsible for overseeing any delegated activities to a CRO and ensuring that the delegation of these activities is documented.


Solutions:

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

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