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ACRP Certified Professional : ACRP-CP

ACRP-CP

Exam Code: ACRP-CP

Exam Name: ACRP Certified Professional Exam

Updated: Aug 12, 2026

Q & A: 127 Questions and Answers

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ACRP ACRP-CP Exam Syllabus Topics:

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

ACRP Certified Professional Sample Questions:

1. A clinical trial is conducted to measure the effectiveness of music therapy to reduce anxiety in intensive care unit patients. Patients are randomly assigned to receive headphones with music of their choice or headphones with white noise. The group receiving the white noise headphones is considered which type of control group?

A) Alternate dose
B) Active control
C) No treatment
D) Placebo


2. The sponsor should supply a PI with the IP after:

A) Approval of protocol by the PI.
B) Approval/favorable opinion from IRB/IEC and regulatory authority.
C) Submission of documents to IRB/IEC and regulatory authority for review.
D) Approval of protocol by the sponsor.


3. A site is starting up a Phase III trial. They have received IRB/IEC approval and have scheduled the SIV. The site cannot begin enrolling subjects until:

A) The site receives approval from the medical monitor to begin enrolling.
B) A signed clinical trial agreement between the site and sponsor is in place.
C) The DSMB meets and the first DSMB meeting report has been issued.
D) The CRA has performed source document review and verification at the site.


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

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


5. Who takes responsibility for initiating a clinical trial?

A) Investigator
B) Sponsor
C) CRO
D) IRB/IEC


Solutions:

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

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