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ACRP ACRP-CP Exam Syllabus Topics:

Section	Weight	Objectives
Topic 1: Ethical and Participant Safety Considerations	19%	- Ethical principles 1. Human subject protections and privacy 2. Clinical equipoise and therapeutic misconception - Safety monitoring and reporting 1. Safety information evaluation and communication 2. Adverse event identification and classification - Clinical care and management of research participants 1. Continuity of medical care 2. Standard of care vs protocol requirements 3. Informed consent development and review
Topic 2: 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
Topic 3: Study Design and Conduct	17%	- Study implementation 1. Study monitoring and oversight 2. Site selection and activation 3. Investigational product management - Study planning 1. Sample size and statistical considerations 2. Study population and eligibility criteria 3. Protocol development and amendments
Topic 4: Professionalism and Ethical Practice	15%	- Professional standards 1. Role responsibilities and boundaries 2. Confidentiality and conflict of interest - Continuous improvement 1. Quality assurance and process improvement 2. Professional development and education
Topic 5: Regulatory and Compliance Requirements	17%	- International standards 1. Declaration of Helsinki - ICH Guidelines 1. E8 General Considerations for Clinical Trials 2. E6(R2)/E6(R3) Good Clinical Practice 3. E2A Expedited Reporting 4. E11 Pediatric Trials 5. E9 Statistical Principles - Compliance procedures 1. Regulatory submissions and approvals 2. Audits and inspections
Topic 6: 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. Database lock and data transfer 2. Data integrity and security

ACRP Certified Professional Sample Questions:

Question #1

Which of the following should be considered when implementing a risk-based monitoring plan?

A. 100% source document review is mandatory.
B. On-site monitoring frequency may change depending on the quality of the data.
C. Centralized monitoring must be incorporated in any trials.
D. Monitoring schedule must be pre-defined in the monitoring plan.

Reveal Solution Discussion 0

Correct Answer: B 🗳️