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ACRP ACRP-CP Exam Syllabus Topics:

Section	Weight	Objectives
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. Human subject protections and privacy 2. Clinical equipoise and therapeutic misconception - 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
Study Design and Conduct	17%	- Study implementation 1. Study monitoring and oversight 2. Site selection and activation 3. Investigational product management - Study planning 1. Protocol development and amendments 2. Study population and eligibility criteria 3. Sample size and statistical considerations
Regulatory and Compliance Requirements	17%	- ICH Guidelines 1. E2A Expedited Reporting 2. E6(R2)/E6(R3) Good Clinical Practice 3. E11 Pediatric Trials 4. E8 General Considerations for Clinical Trials 5. E9 Statistical Principles - Compliance procedures 1. Audits and inspections 2. Regulatory submissions and approvals - International standards 1. Declaration of Helsinki
Data Management and Informatics	17%	- Data reporting 1. Database lock and data transfer 2. Data integrity and security - Data quality control 1. Query management and resolution 2. Data validation and cleaning - Data collection 1. Case report form design and completion 2. Electronic data capture systems
Professionalism and Ethical Practice	15%	- Continuous improvement 1. Quality assurance and process improvement 2. Professional development and education - Professional standards 1. Role responsibilities and boundaries 2. Confidentiality and conflict of interest
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

ACRP Certified Professional Sample Questions:

Question #1

The inclusion and exclusion criteria are in place so all subjects are:

A. Medically appropriate and protected from ethical vulnerability.
B. Ethically vulnerable and patients with the disease under study.
C. Patients with the disease under study and will not have any adverse events.
D. Healthy and willing to complete the clinical trial.

Reveal Solution Discussion 0

Correct Answer: A 🗳️