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ACRP ACRP-CP Exam Syllabus Topics:

Section	Weight	Objectives
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. Data integrity and security 2. Database lock and data transfer
Professionalism and Ethical Practice	15%	- Professional standards 1. Confidentiality and conflict of interest 2. Role responsibilities and boundaries - Continuous improvement 1. Quality assurance and process improvement 2. Professional development and education
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. Study monitoring and oversight 2. Site selection and activation 3. Investigational product management
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
Regulatory and Compliance Requirements	17%	- International standards 1. Declaration of Helsinki - Compliance procedures 1. Audits and inspections 2. Regulatory submissions and approvals - ICH Guidelines 1. E6(R2)/E6(R3) Good Clinical Practice 2. E2A Expedited Reporting 3. E9 Statistical Principles 4. E8 General Considerations for Clinical Trials 5. E11 Pediatric Trials
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

ACRP Certified Professional Sample Questions:

Question #1

A PI is being considered for an industry-sponsored study. The PI sees approximately 20 patients per month who meet the study criteria. The PI does not have access to a Positron Emission Tomography (PET) scanner, which is required for the protocol. The PI is already taking part in three other studies. Should the Sponsor choose this PI?

A. No, the PI is taking part in too many ongoing studies to participate in this study.
B. Yes, the PI has a sufficient patient population to take part in this study.
C. Yes, the PI can perform other imaging scans instead of the PET scans.
D. No, the PI does not have the resources to perform all protocol-required procedures.

Reveal Solution Discussion 0

Correct Answer: D 🗳️