ACRP Certified Professional : ACRP-CP Exam Questions

  • Exam Code: ACRP-CP
  • Exam Name: ACRP Certified Professional Exam
  • Updated: Aug 09, 2026
  • Q&As: 127 Questions and Answers

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ACRP-CP exam dumps

ACRP ACRP-CP Exam Syllabus Topics:

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

ACRP Certified Professional Sample Questions:

1. A quality assurance audit of the EDC system SOP revealed a deficiency. Which of the following is the MOST likely reason?

A) The list of comparable technology solutions was not included.
B) The number of users with access was not defined.
C) The frequency of data backup was not defined.
D) The number of unique eCRF templates was not specified.


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

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


3. In a quality management system, in which category do risk reduction activities belong?

A) Risk Control
B) Risk Evaluation
C) Risk Communication
D) Risk Review


4. Who is responsible for securing agreement from all involved parties to ensure direct access of all trial-related source documents?

A) CRC
B) Sponsor
C) Investigator
D) CRO


5. After the completion or termination of a clinical trial, who should store the enrollment log?

A) Sponsor
B) PI
C) CRO
D) Regulatory authority


Solutions:

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

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