ACRP ACRP-CP Q&A - in .pdf

  • ACRP-CP pdf
  • Exam Code: ACRP-CP
  • Exam Name: ACRP Certified Professional Exam
  • Updated: Aug 15, 2026
  • Q & A: 127 Questions and Answers
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  • Updated: Aug 15, 2026
  • Q & A: 127 Questions and Answers
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ACRP ACRP-CP Q&A - Testing Engine

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ACRP ACRP-CP Exam Syllabus Topics:

SectionWeightObjectives
Regulatory and Compliance Requirements17%- International standards
  • 1. Declaration of Helsinki
- Compliance procedures
  • 1. Regulatory submissions and approvals
  • 2. Audits and inspections
- ICH Guidelines
  • 1. E8 General Considerations for Clinical Trials
  • 2. E9 Statistical Principles
  • 3. E6(R2)/E6(R3) Good Clinical Practice
  • 4. E2A Expedited Reporting
  • 5. E11 Pediatric Trials
Ethical and Participant Safety Considerations19%- Safety monitoring and reporting
  • 1. Adverse event identification and classification
  • 2. Safety information evaluation and communication
- Clinical care and management of research participants
  • 1. Continuity of medical care
  • 2. Standard of care vs protocol requirements
  • 3. Informed consent development and review
- Ethical principles
  • 1. Clinical equipoise and therapeutic misconception
  • 2. Human subject protections and privacy
Professionalism and Ethical Practice15%- Continuous improvement
  • 1. Quality assurance and process improvement
  • 2. Professional development and education
- Professional standards
  • 1. Role responsibilities and boundaries
  • 2. Confidentiality and conflict of interest
Study Design and Conduct17%- Study planning
  • 1. Protocol development and amendments
  • 2. Sample size and statistical considerations
  • 3. Study population and eligibility criteria
- Study implementation
  • 1. Study monitoring and oversight
  • 2. Investigational product management
  • 3. Site selection and activation
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
Data Management and Informatics17%- Data reporting
  • 1. Data integrity and security
  • 2. Database lock and data transfer
- 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

ACRP Certified Professional Sample Questions:

1. Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of the following documents?

A) Protocol, IB, and information about payments and compensation available to subjects
B) Protocol, site coordinator CVs, and clinical trial agreement
C) Protocol, informed consent, and clinical trial agreement
D) IB, site coordinator CVs, and information about payments and compensation available to subjects


2. Who should vote during the IRB/IEC review and discussion process?

A) All IRB/IEC members
B) All members who were involved in the review and discussion and non-member experts
C) All members who were involved in the review and discussion
D) All IRB/IEC members and non-member experts


3. While reviewing a new protocol, a PI realizes a specialized laboratory test is required that the local hospital does not perform. The PI locates a laboratory that performs the specialized test and retains their services.
Responsibility for ensuring the laboratory retained is qualified for this trial-related task lies with the:

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


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

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


5. A study is using an EDC system. After the data is entered into EDC, who is the next to review and conduct SDV of this data?

A) Monitor
B) Sponsor
C) Data Manager
D) QA Department


Solutions:

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

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