ACRP-CP Certification Exam Syllabus
Welcome to the official MedicoExam syllabus guide for the ACRP Certified Professional certification. This page delivers a clear, structured overview of the ACRP-CP exam, including key exam details, syllabus topics, and preparation references to support effective study planning. The ACRP Certified Professional (ACRP-CP) is intended for professionals pursuing roles aligned with Flagship Certification, with assessment centered on applied competencies such as Ethical participant protection and GCP compliance, Clinical trial and site operations, Research design and data management within real-world settings like Clinical research sites and academic medical centers, Sponsors and contract research organizations, Healthcare and life sciences organizations.
The syllabus outline below reflects the core domains and expectations defined by the official ACRP certification framework and aligns with the cognitive and professional standards assessed in the ACRP-CP exam. Candidates can use this guide alongside official vendor resources and structured practice to align their preparation with current exam standards and professional expectations for Clinical research professionals, Clinical trial operations professionals, Study management and regulatory professionals
ACRP-CP Exam Summary and Key Details
| Exam Name | ACRP Certified Professional |
| Credential | ACRP Certified Professional (ACRP-CP) |
| Vendor | Association of Clinical Research Professionals (ACRP) |
| Exam Code | ACRP-CP » ACRP-CP Certification Practice Exam |
| Exam Delivery Mode | Computer-based testing at PSI testing centers or through PSI live remote proctoring |
| Exam Duration | 180 mins |
| Number of Questions | 125 (100 Scored Items / 25 Pretest Items) |
| Passing Score | 600 (on a scaled of 200-800) |
| Exam Price |
Early Bird Registration - ACRP Members – $435 - Nonmembers – $485 Regular Registration - ACRP Members – $460 - Nonmembers – $600 |
| Scheduling Window | Two annual testing windows; 2026 Spring window February 15–May 15 and Fall window July 15–October 15 |
| Schedule Exam | ACRP |
| Trainings/Resources | ACRP Certification Exam Preparation Resources |
| Sample Questions | ACRP-CP Exam Sample Questions |
| Recommended Practice | ACRP-CP Certification Practice Exam |
ACRP-CP Exam Syllabus Topics and Weighting
| Topic Areas | Topic Details, Courses, Books | Weighting |
|---|---|---|
| Ethical and Participant Safety Considerations |
- Standard of care vs. clinical research protocol requirements - Clinical equipoise vs. therapeutic misconception - Content of the key documents ensuring subject protection (e.g., IB, protocol, informed consent documents) - Considerations for vulnerable populations - Past and current ethical issues in clinical research (e.g., diversity) - Risks vs. benefits in the selection of research subjects - Unblinding procedures - Confidentiality and privacy - Elements and process of informed consent/assent - Protocol deviation/violation identification, documentation, and reporting processes - Recruitment and retention plan/strategies - Safety monitoring and reporting - Subject discontinuation criteria/procedures - Conflict of interest in clinical research - Fraud and misconduct |
18 |
| Clinical Research Standards and Guidelines |
- Stakeholders and regulatory institutions and frameworks in clinical research - Phases of clinical research - Regulatory reporting requirements (e.g., pre- and post-approval, safety) - Standards for handling hazardous goods, materials, and biological samples - Audit and inspection processes (preparation, participation, documentation, and follow-up) - IRB/IEC role, composition, purpose, and reporting requirements - Protocol submission, approval, and amendment processes - Efficacy and safety evaluation milestones (e.g., interim analysis result, DSMB review |
17 |
| Clinical Trial Operations (GCPs) |
- Conduct, documentation, and management of clinical trials - Study staff roles, training, qualifications, and delegation of responsibilities - Control, storage, and dispensation of investigational products/devices - Adverse event classification, reporting, and management - Study reporting requirements (e.g., SAEs, deviations, INDs, IRB) - Study monitoring - Audits and inspections - Protocol/GCP deviation identification and management - IRB/IEC requirements such as submission, review, and approval of documents - Corrective and preventive action (CAPA) processes - Source data review and verification - Site selection activities - Principal investigator responsibilities - Roles of various clinical trial entities (e.g., CROs, sponsors, regulatory authority) - Site initiation, maintenance, and closeout activities |
25 |
| Study and Site Management |
- Quality management activities in the conduct of clinical research - Responsibilities and obligations involved in the conduct of a clinical trial - Oversight requirements of PIs, sponsors, contract research organizations (CROs), and regulatory authorities - Contractual agreements (e.g., budgets, clinical trial agreement) - Maintenance and use of equipment and supplies - Investigational product/device accountability and documentation requirements - Investigational product/device reference materials (e.g., Investigator brochure, instructions for use, user manual) - Non-compliance management - Sample collection, storage, disposal, and shipment requirements - Assessment of subject compliance - Study evaluation for feasibility - Record retention and destruction practices and requirements - Essential documents for the conduct of a clinical trial (e.g., trial master file) |
21 |
| Research Design and Data Management |
- Clinical trial design (e.g., double-blind, cross-over, randomization) - Elements of a protocol - Elements and purpose of an Investigational Brochure (IB) and Instructions for Use - Rationale for subject eligibility requirements - Study objectives, hypotheses, and end points/outcomes - Basic concepts of biostatistics and informatics in research - Flow of data throughout clinical research - Data collection, correction, and queries (e.g., electronic data capture, audit trails) - Data quality systems and privacy principles - Study documentation practices (ALCOA-C) |
19 |
The ACRP-CP certification exam is designed to assess both theoretical knowledge and applied professional judgment in Flagship Certification. The exam evaluates competencies such as Ethical participant protection and GCP compliance, Clinical trial and site operations, Research design and data management, ensuring candidates are prepared for real-world responsibilities as Clinical research professionals, Clinical trial operations professionals, Study management and regulatory professionals working in settings such as Clinical research sites and academic medical centers, Sponsors and contract research organizations, Healthcare and life sciences organizations.
To prepare effectively for the ACRP Certified Professional exam, candidates are encouraged to review official vendor materials, complete structured practice assessments, and gain hands-on experience relevant to their professional role.
