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ACRP ACRP-CP Exam Syllabus Topics:

Section	Weight	Objectives
Regulatory and Compliance Requirements	17%	- International standards 1. Declaration of Helsinki - Compliance procedures 1. Regulatory submissions and approvals 2. Audits and inspections - ICH Guidelines 1. E11 Pediatric Trials 2. E9 Statistical Principles 3. E8 General Considerations for Clinical Trials 4. E2A Expedited Reporting 5. E6(R2)/E6(R3) Good Clinical Practice
Ethical and Participant Safety Considerations	19%	- Safety monitoring and reporting 1. Adverse event identification and classification 2. Safety information evaluation and communication - 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 - Ethical principles 1. Clinical equipoise and therapeutic misconception 2. Human subject protections and privacy
Study Design and Conduct	17%	- Study implementation 1. Site selection and activation 2. Investigational product management 3. Study monitoring and oversight - Study planning 1. Sample size and statistical considerations 2. Protocol development and amendments 3. Study population and eligibility criteria
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. Electronic data capture systems 2. Case report form design and completion - Data reporting 1. Database lock and data transfer 2. Data integrity and security - Data quality control 1. Data validation and cleaning 2. Query management and resolution
Clinical Study Operations	15%	- Site management 1. Study documentation and record keeping 2. Site personnel training and delegation - Project management 1. Timeline and budget management 2. Vendor and stakeholder management

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

Reveal Solution Discussion 0

Correct Answer: C 🗳️