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ACRP ACRP-CP exam : ACRP Certified Professional Exam

ACRP-CP Exam Questions
  • Exam Code: ACRP-CP
  • Exam Name: ACRP Certified Professional Exam
  • Updated: Aug 11, 2026
  • Q & A: 127 Questions and Answers
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ACRP ACRP-CP Exam Syllabus Topics:

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

ACRP Certified Professional Sample Questions:

1. The PI should ensure that source data is:

A) On worksheets that are provided by the sponsor.
B) Accurately reflected in the eCRFs.
C) Kept on site for a minimum of 2 years.
D) Printed directly from the EMR.


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


3. All of the following are steps to assure an effective risk management approach while conducting a clinical study EXCEPT:

A) Controlling risk by setting thresholds of risk acceptability.
B) Assessing risk based on study impact.
C) Documenting all possible risk scenarios.
D) Identifying potential study risks.


4. The inclusion and exclusion criteria are in place so all subjects are:

A) Patients with the disease under study and will not have any adverse events.
B) Healthy and willing to complete the clinical trial.
C) Medically appropriate and protected from ethical vulnerability.
D) Ethically vulnerable and patients with the disease under study.


5. Confidentiality and privacy rules for protection of human subjects at research sites are determined by the:

A) Applicable regulatory authorities
B) Sponsor
C) PI
D) Applicable site SOPs


Solutions:

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

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