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
Topic 1: Study Design and Conduct	17%	- Study implementation 1. Study monitoring and oversight 2. Investigational product management 3. Site selection and activation - Study planning 1. Protocol development and amendments 2. Sample size and statistical considerations 3. Study population and eligibility criteria
Topic 2: 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
Topic 3: 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
Topic 4: Ethical and Participant Safety Considerations	19%	- 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 - Ethical principles 1. Clinical equipoise and therapeutic misconception 2. Human subject protections and privacy - Safety monitoring and reporting 1. Adverse event identification and classification 2. Safety information evaluation and communication
Topic 5: 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. E9 Statistical Principles 2. E8 General Considerations for Clinical Trials 3. E2A Expedited Reporting 4. E11 Pediatric Trials 5. E6(R2)/E6(R3) Good Clinical Practice
Topic 6: Data Management and Informatics	17%	- Data reporting 1. Database lock and data transfer 2. Data integrity and security - Data quality control 1. Data validation and cleaning 2. Query management and resolution - Data collection 1. Electronic data capture systems 2. Case report form design and completion

ACRP Certified Professional Sample Questions:

Question #1

A trial subject was involved in a traffic accident. The emergency room (ER) doctor notifies the investigator that he wants to give the subject a blood transfusion. Blood transfusion is one of the prohibited treatments in the trial. How should the investigator respond?

A. Ask the ER doctor not to transfuse blood and consider another treatment compliant with the protocol.
B. Advise the ER doctor to transfuse blood, and the PI should withdraw the subject from the trial.
C. Advise the ER doctor to transfuse the blood, and the PI should report this incident to the sponsor.
D. Report this incident immediately to the sponsor and leave the treatment decision to them.

Reveal Solution Discussion 0

Correct Answer: C 🗳️