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Last Updated: Aug 17, 2026

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ACRP ACRP-CP Exam Syllabus Topics:

SectionObjectives
Topic 1: Data Management and Documentation- Clinical trial documentation
  • 1. Source documentation
  • 2. Essential documents
- Data integrity
  • 1. Data collection
  • 2. Query resolution
Topic 2: Quality Management- Audit and inspection readiness
  • 1. Inspection preparation
  • 2. Compliance monitoring
- Risk management
  • 1. Corrective and preventive actions
  • 2. Quality assurance
Topic 3: Professional Responsibilities- Leadership and professionalism
  • 1. Professional ethics
  • 2. Decision making
- Communication and collaboration
  • 1. Cross-functional teamwork
  • 2. Stakeholder communication
Topic 4: Ethical and Participant Safety Considerations- Regulatory compliance
  • 1. ICH GCP adherence
  • 2. IRB and ethics requirements
- Human subject protection
  • 1. Participant rights
  • 2. Informed consent
Topic 5: Clinical Trial Operations- Study start-up activities
  • 1. Site preparation
  • 2. Protocol implementation
- Study conduct
  • 1. Participant management
  • 2. Safety reporting

ACRP Certified Professional Sample Questions:

1. Source data/documentation should be:

A) Attributable, legible, correct, original, accurate, and clear.
B) Attributable, legible, contemporaneous, original, accurate, and complete.
C) Attributable, legible, correct, original, accurate, and complete.
D) Attributable, legible, contemporaneous, original, accurate, and clear.


2. Who is responsible for defining, establishing, and allocating all trial-related duties and functions prior to initiating a trial?

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


3. Who is responsible for submitting a protocol amendment to the IRB/IEC?

A) CRC
B) Investigator
C) CRA
D) Sponsor


4. The IB contains which of the following sections?

A) IP preparation instructions
B) Known pharmacokinetic effects
C) Participant eligibility criteria
D) Participant dosing schedule


5. The sponsor must report a serious unexpected AE to the regulatory authorities within a maximum of:

A) 7 calendar days
B) 30 calendar days
C) 15 calendar days
D) 8 calendar days


Solutions:

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

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