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ACRP ACRP-CP Exam Syllabus Topics:

Section	Weight	Objectives
Topic 1: Ethical and Participant Safety Considerations	19%	- 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 - 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
Topic 2: Regulatory and Compliance Requirements	17%	- ICH Guidelines 1. E2A Expedited Reporting 2. E11 Pediatric Trials 3. E9 Statistical Principles 4. E8 General Considerations for Clinical Trials 5. E6(R2)/E6(R3) Good Clinical Practice - Compliance procedures 1. Audits and inspections 2. Regulatory submissions and approvals - International standards 1. Declaration of Helsinki
Topic 3: 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
Topic 4: Data Management and Informatics	17%	- Data collection 1. Electronic data capture systems 2. Case report form design and completion - Data quality control 1. Data validation and cleaning 2. Query management and resolution - Data reporting 1. Database lock and data transfer 2. Data integrity and security
Topic 5: Study Design and Conduct	17%	- Study planning 1. Protocol development and amendments 2. Study population and eligibility criteria 3. Sample size and statistical considerations - Study implementation 1. Investigational product management 2. Study monitoring and oversight 3. Site selection and activation
Topic 6: 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

ACRP Certified Professional Sample Questions:

Question #1

A study sponsor approaches a facility about participating in their research study. The study sponsor requires use of social media as its sole method of recruitment. The site knows their institutional IRB/IEC does not approve of social media recruiting. How should the site respond?

A. Rely on the sponsor to notify the IRB/IEC.
B. Recruit for the study without use of social media.
C. Use a central IRB/IEC.
D. Decline the study.

Reveal Solution Discussion 0

Correct Answer: D 🗳️