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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 reporting 1. Data integrity and security 2. Database lock and data transfer - Data quality control 1. Query management and resolution 2. Data validation and cleaning
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
Clinical Study Operations	15%	- Site management 1. Study documentation and record keeping 2. Site personnel training and delegation - Project management 1. Vendor and stakeholder management 2. Timeline and budget management
Study Design and Conduct	17%	- Study planning 1. Sample size and statistical considerations 2. Study population and eligibility criteria 3. Protocol development and amendments - Study implementation 1. Study monitoring and oversight 2. Investigational product management 3. Site selection and activation
Ethical and Participant Safety Considerations	19%	- Clinical care and management of research participants 1. Informed consent development and review 2. Continuity of medical care 3. Standard of care vs protocol requirements - 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
Regulatory and Compliance Requirements	17%	- ICH Guidelines 1. E11 Pediatric Trials 2. E9 Statistical Principles 3. E6(R2)/E6(R3) Good Clinical Practice 4. E2A Expedited Reporting 5. E8 General Considerations for Clinical Trials - International standards 1. Declaration of Helsinki - Compliance procedures 1. Regulatory submissions and approvals 2. Audits and inspections

ACRP Certified Professional Sample Questions:

Question #1

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

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

Reveal Solution Discussion 0

Correct Answer: C 🗳️