ACRP-CP exam dumps

ACRP ACRP-CP Value Package

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  • Exam Code: ACRP-CP
  • Exam Name: ACRP Certified Professional Exam
  • No. of Questions: 127 Questions and Answers
  • Updated: Aug 15, 2026

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ACRP ACRP-CP Exam Syllabus Topics:

SectionWeightObjectives
Regulatory and Compliance Requirements17%- ICH Guidelines
  • 1. E6(R2)/E6(R3) Good Clinical Practice
  • 2. E8 General Considerations for Clinical Trials
  • 3. E2A Expedited Reporting
  • 4. E11 Pediatric Trials
  • 5. E9 Statistical Principles
- Compliance procedures
  • 1. Regulatory submissions and approvals
  • 2. Audits and inspections
- International standards
  • 1. Declaration of Helsinki
Data Management and Informatics17%- Data quality control
  • 1. Data validation and cleaning
  • 2. Query management and resolution
- 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
Clinical Study Operations15%- Site management
  • 1. Site personnel training and delegation
  • 2. Study documentation and record keeping
- 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. Professional development and education
  • 2. Quality assurance and process improvement
Ethical and Participant Safety Considerations19%- Safety monitoring and reporting
  • 1. Adverse event identification and classification
  • 2. Safety information evaluation and communication
- 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. Standard of care vs protocol requirements
  • 3. Continuity of medical care
Study Design and Conduct17%- Study implementation
  • 1. Study monitoring and oversight
  • 2. Investigational product management
  • 3. Site selection and activation
- Study planning
  • 1. Sample size and statistical considerations
  • 2. Protocol development and amendments
  • 3. Study population and eligibility criteria

ACRP Certified Professional Sample Questions:

1. 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) Ship/receive IP
C) Obtain IRB/IEC approval
D) Schedule a site initiation visit


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

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


3. Who must be blinded in a double-blind study in order to prevent bias?

A) Pharmacist
B) Data entry staff
C) IRB/IEC
D) Subject


4. Which of the following should be reviewed and evaluated by qualified experts to assess implications for the safety of the trial subjects?

A) Sample collection storage, disposal, and shipment requirements
B) PI roles and responsibilities
C) Project feasibility considerations
D) Emerging animal toxicological and clinical data


5. When determining whether a protocol deviation (PD) is reportable to the IRB/IEC, the PI should take into consideration whether the:

A) Sponsor approved the PD.
B) Participant verbally agreed to the PD.
C) PD affected participant recruitment.
D) PD affected participant safety.


Solutions:

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

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