ACRP ACRP-CP : ACRP Certified Professional Exam

  • Exam Code: ACRP-CP
  • Exam Name: ACRP Certified Professional Exam
  • Updated: Aug 06, 2026   Q&As: 127 Questions and Answers

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ACRP ACRP-CP Exam Syllabus Topics:
SectionWeightObjectives
Regulatory and Compliance Requirements17%- International standards
  • 1. Declaration of Helsinki
- ICH Guidelines
  • 1. E6(R2)/E6(R3) Good Clinical Practice
  • 2. E9 Statistical Principles
  • 3. E11 Pediatric Trials
  • 4. E8 General Considerations for Clinical Trials
  • 5. E2A Expedited Reporting
- Compliance procedures
  • 1. Regulatory submissions and approvals
  • 2. Audits and inspections
Study Design and Conduct17%- Study implementation
  • 1. Investigational product management
  • 2. Study monitoring and oversight
  • 3. Site selection and activation
- Study planning
  • 1. Protocol development and amendments
  • 2. Study population and eligibility criteria
  • 3. Sample size and statistical considerations
Clinical Study Operations15%- Project management
  • 1. Vendor and stakeholder management
  • 2. Timeline and budget management
- Site management
  • 1. Study documentation and record keeping
  • 2. Site personnel training and delegation
Data Management and Informatics17%- Data collection
  • 1. Case report form design and completion
  • 2. Electronic data capture systems
- 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
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%- Clinical care and management of research participants
  • 1. Informed consent development and review
  • 2. Standard of care vs protocol requirements
  • 3. Continuity of medical care
- Ethical principles
  • 1. Human subject protections and privacy
  • 2. Clinical equipoise and therapeutic misconception
- Safety monitoring and reporting
  • 1. Adverse event identification and classification
  • 2. Safety information evaluation and communication
ACRP Certified Professional Sample Questions:

1. A PI on a study is a regular member of the IRB/IEC. Which of the following statements is TRUE regarding their participation in the IRB/IEC discussion and deliberation?

A) They cannot be the PI on the clinical study due to conflict of interest.
B) They can attend the meeting and can vote/provide opinion on whether to approve the study.
C) They can attend the meeting, but should not vote/provide opinion on whether to approve the study.
D) They must recuse themselves from the meeting given their dual roles as IRB/IEC member and PI.


2. Who is responsible to ensure training for key staff members unable to attend the site initiation visit?

A) Monitor
B) Coordinator
C) Sponsor
D) Investigator


3. A PI is being considered for an industry-sponsored study. The PI sees approximately 20 patients per month who meet the study criteria. The PI does not have access to a Positron Emission Tomography (PET) scanner, which is required for the protocol. The PI is already taking part in three other studies. Should the Sponsor choose this PI?

A) No, the PI does not have the resources to perform all protocol-required procedures.
B) No, the PI is taking part in too many ongoing studies to participate in this study.
C) Yes, the PI has a sufficient patient population to take part in this study.
D) Yes, the PI can perform other imaging scans instead of the PET scans.


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

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


5. 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.


Solutions:

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

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