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ACRP ACRP-CP Exam Syllabus Topics:

Section	Weight	Objectives
Topic 1: Study Design and Conduct	17%	- Study implementation 1. Study monitoring and oversight 2. Investigational product management 3. Site selection and activation - Study planning 1. Sample size and statistical considerations 2. Study population and eligibility criteria 3. Protocol development and amendments
Topic 2: Professionalism and Ethical Practice	15%	- Professional standards 1. Confidentiality and conflict of interest 2. Role responsibilities and boundaries - Continuous improvement 1. Professional development and education 2. Quality assurance and process improvement
Topic 3: Data Management and Informatics	17%	- Data collection 1. Electronic data capture systems 2. Case report form design and completion - 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
Topic 4: Ethical and Participant Safety Considerations	19%	- Ethical principles 1. Clinical equipoise and therapeutic misconception 2. Human subject protections and privacy - Safety monitoring and reporting 1. Safety information evaluation and communication 2. Adverse event identification and classification - Clinical care and management of research participants 1. Standard of care vs protocol requirements 2. Informed consent development and review 3. Continuity of medical care
Topic 5: Clinical Study Operations	15%	- Site management 1. Site personnel training and delegation 2. Study documentation and record keeping - Project management 1. Timeline and budget management 2. Vendor and stakeholder management
Topic 6: 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. E8 General Considerations for Clinical Trials 2. E11 Pediatric Trials 3. E6(R2)/E6(R3) Good Clinical Practice 4. E9 Statistical Principles 5. E2A Expedited Reporting

ACRP Certified Professional Sample Questions:

Question #1

A PI is reviewing the CRF for a recent subject visit and notices the participant's heart rate and temperature are not recorded. Which of the following study documentation practices was neglected?

A. Contemporaneous
B. Attributable
C. Complete
D. Original

Reveal Solution Discussion 0

Correct Answer: C 🗳️