ACRP-CP Questions & Answers & ACRP-CP Study Guide & ACRP-CP Exam Preparation

ACRP ACRP-CP : ACRP Certified Professional Exam

Exam Code: ACRP-CP

Exam Name: ACRP Certified Professional Exam

Updated: Aug 09, 2026

Q & A: 127 Questions and Answers

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ACRP ACRP-CP Exam Syllabus Topics:

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

ACRP Certified Professional Sample Questions:

1. A representative from a regulatory authority shows up unannounced at a research site. After confirming their credentials, the representative requested to view the entire records, including identifiable information, from study XYZ that was closed out. Which of the following should the site personnel do next?

A) Redact subject identification for privacy protection.
B) Deny the request until the sponsor approves.
C) Consult with the IRB/IEC first.
D) Allow access to the entire records.


2. Upon receipt of temperature-controlled IP, the study staff noticed the IP incurred a temperature excursion during transport. What should the staff do NEXT?

A) Dispose of IP and request replacement from sponsor.
B) Register IP in IWRS, quarantine and notify sponsor of the excursion.
C) Quarantine IP without registering in IWRS and request replacement from sponsor.
D) Register IP in IWRS and continue with subject allocation.


3. A potential subject is interested in a new clinical trial and would like to learn more about the risks and benefits of participation. Where can they find this information?

A) ICF
B) Package insert
C) Protocol
D) IB


4. Who ensures information regarding payments to subjects is documented in a written consent form?

A) Coordinator
B) PI
C) IRB/IEC
D) Sponsor


5. 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) Notify the sponsor.
B) Call the participant to return for an unscheduled visit.
C) Report a protocol deviation to the IRB/IEC.
D) Notify the PI.


Solutions:

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

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