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ACRP ACRP Certified Professional ACRP-CP

ACRP-CP

Exam Code: ACRP-CP

Exam Name: ACRP Certified Professional Exam

Updated: Aug 05, 2026

Q & A: 127 Questions and Answers

ACRP-CP Free Demo download:

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ACRP ACRP-CP Exam Syllabus Topics:

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

ACRP Certified Professional Sample Questions:

1. A serious unexpected ADR is one:

A) Where the severity of the reaction is not consistent with IB.
B) Severity and nature of the reaction is consistent with protocol.
C) That does not need to be reported to the IRB/IEC.
D) That results in the death of the subject.


2. Who ensures information regarding payments to subjects is documented in a written consent form?

A) IRB/IEC
B) Sponsor
C) Coordinator
D) PI


3. A clinical trial is conducted to test the effect of an investigational drug on cholesterol levels. Statistical analysis will be performed to:

A) Fail to reject the alternative hypothesis that the drug has an effect on cholesterol levels.
B) Reject the null hypothesis that the drug has no effect on cholesterol levels.
C) Reject the alternative hypothesis that the drug has no effect on cholesterol levels.
D) Fail to reject the null hypothesis that the drug has an effect on cholesterol levels.


4. A subject became pregnant 16 weeks into a clinical trial. She has been taking a daily dose of IP since enrollment. The baby was born missing two toes on each foot. How should this be reported by the site?

A) This needs to be reported to the regulatory authorities within 10 business days.
B) This qualifies for expedited reporting to the sponsor.
C) This needs to be reported to the patient's primary care physician.
D) This qualifies for prompt reporting to the IRB/IEC within 15 business days.


5. A written description of a trial in which the clinical and statistical description, presentations, and analyses are fully integrated into a single document is called a:

A) IDMC/DSMB Report
B) Investigator Brochure
C) Clinical Study Report
D) Clinical Study Protocol


Solutions:

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

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