ACRP ACRP-CP : ACRP Certified Professional Exam

  • Exam Code: ACRP-CP
  • Exam Name: ACRP Certified Professional Exam
  • Updated: Aug 16, 2026

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ACRP ACRP-CP Exam Syllabus Topics:

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

ACRP Certified Professional Sample Questions:

1. A new device trial is being considered. Before committing to participate in the trial, what is the MOST important item the PI needs to evaluate?

A) Information to be included in the advertising flyer
B) Availability of qualified staff to conduct the trial
C) Location of stored trial records
D) Length of time to receive the approved trial device


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


3. The site submitted all start-up documents for a study to the sponsor and the IRB/IEC. The site also has subjects identified for screening. What should happen FIRST?

A) Verify subject eligibility
B) Schedule a site initiation visit
C) Ship/receive IP
D) Obtain IRB/IEC approval


4. The CRC is prepared to consent a cognitively impaired participant to an Alzheimer's clinical trial. The CRC is required to utilize which of the following in the consent process?

A) A legally acceptable representative
B) A family member
C) A witness
D) A member of the research team


5. A protocol requires participants to take IP for 6 months. The protocol allows for any participants who are noncompliant to be replaced by enrolling additional participants, except if it is due to an AE. The investigator has enrolled 12 participants.
The status of the enrolled participants is as follows:
* 3 participants were withdrawn due to noncompliance
* 1 participant withdrew consent after experiencing severe nausea
* 1 participant had to discontinue IP for an unscheduled hospitalization
* 1 participant who is not returning for visits
* 2 participants completed the 6 months of treatment
* 4 participants currently on IP
How many participants should be replaced?

A) 5 participants
B) 4 participants
C) 6 participants
D) 3 participants


Solutions:

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

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