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ACRP ACRP-CP Exam Syllabus Topics:

Section	Weight	Objectives
Topic 1: Data Management and Informatics	17%	- Data quality control 1. Query management and resolution 2. Data validation and cleaning - Data collection 1. Electronic data capture systems 2. Case report form design and completion - Data reporting 1. Database lock and data transfer 2. Data integrity and security
Topic 2: Ethical and Participant Safety Considerations	19%	- 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. Standard of care vs protocol requirements 3. Continuity of medical care - Ethical principles 1. Clinical equipoise and therapeutic misconception 2. Human subject protections and privacy
Topic 3: Regulatory and Compliance Requirements	17%	- ICH Guidelines 1. E8 General Considerations for Clinical Trials 2. E6(R2)/E6(R3) Good Clinical Practice 3. E9 Statistical Principles 4. E11 Pediatric Trials 5. E2A Expedited Reporting - Compliance procedures 1. Audits and inspections 2. Regulatory submissions and approvals - International standards 1. Declaration of Helsinki
Topic 4: 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
Topic 5: 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
Topic 6: Study Design and Conduct	17%	- Study implementation 1. Site selection and activation 2. Investigational product management 3. Study monitoring and oversight - Study planning 1. Protocol development and amendments 2. Study population and eligibility criteria 3. Sample size and statistical considerations

ACRP Certified Professional Sample Questions:

Question #1

IP is dispensed to all subjects who:

A. Consented for the trial.
B. Are eligible to receive it in the trial.
C. Need IP for their medical condition.
D. Screened for the trial.

Reveal Solution Discussion 0

Correct Answer: B 🗳️