ACRP ACRP-CP Q&A - in .pdf

Exam Code: ACRP-CP
Exam Name: ACRP Certified Professional Exam
Updated: Oct 02, 2026
Q & A: 127 Questions and Answers
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Exam Code: ACRP-CP
Exam Name: ACRP Certified Professional Exam
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Q & A: 127 Questions and Answers
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ACRP ACRP-CP Exam Syllabus Topics:

Section	Weight	Objectives
Clinical Study Operations	15%	- Project management 1. Timeline and budget management 2. Vendor and stakeholder management - Site management 1. Site personnel training and delegation 2. Study documentation and record keeping
Professionalism and Ethical Practice	15%	- Continuous improvement 1. Professional development and education 2. Quality assurance and process improvement - Professional standards 1. Confidentiality and conflict of interest 2. Role responsibilities and boundaries
Data Management and Informatics	17%	- Data collection 1. Case report form design and completion 2. Electronic data capture systems - Data quality control 1. Query management and resolution 2. Data validation and cleaning - Data reporting 1. Data integrity and security 2. Database lock and data transfer
Ethical and Participant Safety Considerations	19%	- 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. Standard of care vs protocol requirements 2. Continuity of medical care 3. Informed consent development and review
Regulatory and Compliance Requirements	17%	- Compliance procedures 1. Audits and inspections 2. Regulatory submissions and approvals - International standards 1. Declaration of Helsinki - ICH Guidelines 1. E9 Statistical Principles 2. E2A Expedited Reporting 3. E6(R2)/E6(R3) Good Clinical Practice 4. E11 Pediatric Trials 5. E8 General Considerations for Clinical Trials
Study Design and Conduct	17%	- Study planning 1. Sample size and statistical considerations 2. Study population and eligibility criteria 3. Protocol development and amendments - Study implementation 1. Site selection and activation 2. Investigational product management 3. Study monitoring and oversight

ACRP Certified Professional Sample Questions:

Question #1

A protocol inclusion criterion requires the serum magnesium at screening to be within the normal range. After the subject received IP, the CRC discovers the subject's screening magnesium level was below the normal range and the sub-investigator marked the lab sheet as not clinically significant. Which of the following should be done FIRST?

A. Notify the sponsor.
B. Notify the subject.
C. Notify the regulatory authority.
D. Withdraw the subject.

Reveal Solution Discussion 0

Correct Answer: A 🗳️