Exam Code: ACRP-CP
Exam Name: ACRP Certified Professional Exam
Certification Provider: ACRP
Corresponding Certification: ACRP Certified Professional

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ACRP ACRP-CP Exam Syllabus Topics:

Section	Weight	Objectives
Data Management and Informatics	17%	- 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 - Data collection 1. Case report form design and completion 2. Electronic data capture systems
Regulatory and Compliance Requirements	17%	- Compliance procedures 1. Audits and inspections 2. Regulatory submissions and approvals - International standards 1. Declaration of Helsinki - ICH Guidelines 1. E2A Expedited Reporting 2. E6(R2)/E6(R3) Good Clinical Practice 3. E8 General Considerations for Clinical Trials 4. E11 Pediatric Trials 5. E9 Statistical Principles
Professionalism and Ethical Practice	15%	- Continuous improvement 1. Quality assurance and process improvement 2. Professional development and education - Professional standards 1. Confidentiality and conflict of interest 2. Role responsibilities and boundaries
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. Adverse event identification and classification 2. Safety information evaluation and communication - 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
Clinical Study Operations	15%	- Site management 1. Site personnel training and delegation 2. Study documentation and record keeping - Project management 1. Vendor and stakeholder management 2. Timeline and budget management
Study Design and Conduct	17%	- Study planning 1. Study population and eligibility criteria 2. Sample size and statistical considerations 3. Protocol development and amendments - Study implementation 1. Investigational product management 2. Site selection and activation 3. Study monitoring and oversight

ACRP Certified Professional Sample Questions:

Question #1

The investigator/institution should permit:

A. Monitoring and auditing by the appropriate regulatory authority(ies), and inspection by the sponsor.
B. Monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies).
C. Monitoring and inspection by the sponsor, and auditing by the appropriate regulatory authority(ies).
D. Monitoring and inspection by the appropriate regulatory authority(ies), and auditing by the sponsor.

Reveal Solution Discussion 0

Correct Answer: D 🗳️