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ACRP ACRP-CP Exam Syllabus Topics:

Section	Weight	Objectives
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
Ethical and Participant Safety Considerations	19%	- Ethical principles 1. Clinical equipoise and therapeutic misconception 2. Human subject protections and privacy - Clinical care and management of research participants 1. Continuity of medical care 2. Informed consent development and review 3. Standard of care vs protocol requirements - Safety monitoring and reporting 1. Adverse event identification and classification 2. Safety information evaluation and communication
Study Design and Conduct	17%	- Study planning 1. Study population and eligibility criteria 2. Protocol development and amendments 3. Sample size and statistical considerations - Study implementation 1. Investigational product management 2. Site selection and activation 3. Study monitoring and oversight
Data Management and Informatics	17%	- Data quality control 1. Data validation and cleaning 2. Query management and resolution - Data collection 1. Case report form design and completion 2. Electronic data capture systems - Data reporting 1. Data integrity and security 2. Database lock and data transfer
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. E8 General Considerations for Clinical Trials 3. E9 Statistical Principles 4. E11 Pediatric Trials 5. E2A Expedited Reporting
Clinical Study Operations	15%	- Site management 1. Study documentation and record keeping 2. Site personnel training and delegation - Project management 1. Timeline and budget management 2. Vendor and stakeholder management

ACRP Certified Professional Sample Questions:

Question #1

A quality assurance audit of the EDC system SOP revealed a deficiency. Which of the following is the MOST likely reason?

A. The number of unique eCRF templates was not specified.
B. The frequency of data backup was not defined.
C. The number of users with access was not defined.
D. The list of comparable technology solutions was not included.

Reveal Solution Discussion 0

Correct Answer: B 🗳️

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Question #2

A study sponsor approaches a facility about participating in their research study. The study sponsor requires use of social media as its sole method of recruitment. The site knows their institutional IRB/IEC does not approve of social media recruiting. How should the site respond?

A. Use a central IRB/IEC.
B. Decline the study.
C. Rely on the sponsor to notify the IRB/IEC.
D. Recruit for the study without use of social media.

Reveal Solution Discussion 0

Correct Answer: B 🗳️

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Question #3

A written description of a trial in which the clinical and statistical description, presentations, and analyses are fully integrated into a single document is called a: