ACRP CCRC Certification Exam Syllabus
Welcome to the official MedicoExam syllabus guide for the ACRP Certified Clinical Research Coordinator certification. This page delivers a clear, structured overview of the ACRP CCRC exam, including key exam details, syllabus topics, and preparation references to support effective study planning. The ACRP Certified Clinical Research Coordinator (CCRC) is intended for professionals pursuing roles aligned with Flagship Certification, with assessment centered on applied competencies such as participant consent and safety management, protocol and site compliance, data collection and study documentation within real-world settings like clinical trial investigator sites, academic medical centers, hospitals and healthcare research institutions.
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 CCRC 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 coordinators, study coordinators, research site operations professionals
ACRP CCRC Exam Summary and Key Details
| Exam Name | ACRP Certified Clinical Research Coordinator |
| Credential | ACRP Certified Clinical Research Coordinator (CCRC) |
| Vendor | Association of Clinical Research Professionals (ACRP) |
| Exam Code | CCRC » ACRP CCRC Certification Practice Exam |
| Exam Delivery Mode | Computer-based testing at PSI test centers or computer-based 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 (USD) |
| Scheduling Window | Spring testing: February 15–May 15; fall testing: July 15–October 15 |
| Schedule Exam | ACRP |
| Trainings/Resources | ACRP Certification Exam Preparation Resources |
| Sample Questions | ACRP CCRC Exam Sample Questions |
| Recommended Practice | ACRP CCRC Certification Practice Exam |
ACRP CCRC Exam Syllabus Topics and Weighting
| Topic Areas | Topic Details, Courses, Books | Weighting |
|---|---|---|
| Scientific Concepts and Research Design |
- Elements of a protocol - Elements of an Investigational Brochure (IB) and/or investigational device use - Elements of and rationale for subject eligibility requirements - Rationale for complying with a protocol - Statistical principles related to study design (e.g., sample size, screen fail rate) - Study design characteristics (e.g., double-blind, crossover, randomized) - Study objective(s) - Study endpoints/outcomes - Rationale for using supplemental/rescue/comparator product in study design - Treatment assignments (e.g., randomization, open label, registries) |
8 |
| Ethical and Participant Safety Considerations |
- Adverse events classification, documentation and reporting - Blinding/unblinding procedures - Components of subject eligibility requirements - Confidentiality and privacy requirements - Elements of the IB related to identifying risks and benefits - Elements of the informed consent form - Informed consent process requirements (e.g., paper, eConsent, assent) - Protection of human subjects including vulnerable subject populations - Protocol deviation/violation identification, documentation, and reporting processes - Subject recruitment and retention plan/strategies (e.g., social media, digital, print) - Safety monitoring and elements of pharmacovigilance and/or product/device vigilance (e.g., CIOMS, IDMC/DSMB, safety databases) - Subject discontinuation criteria/procedures - Subject safety - Conflicts of interest in clinical research - Ethical responsibilities including fraud and misconduct |
19 |
| Product Development and Regulation |
- Audit and inspection processes (preparation, participation, documentation, and follow-up) - Clinical development process (e.g., preclinical, clinical trial phases, device class) - Clinical trial registries and requirements - Elements of fraud and misconduct - IRB/IEC and other regulatory body reporting requirements - IRB/IEC role, composition, and purpose - Protocol and protocol amendment submission and approval processes - Safety reporting requirements - Significant milestones in the evaluation of efficacy and safety (e.g., interim analysis result, DSMB review) |
13 |
| Clinical Trial Operations (GCPs) |
- Site staff qualifications for delegation of responsibilities, duties, and training requirements - Elements of effective corrective and preventive action (CAPA) process(es) and plan(s) - Monitoring activities (frequency of visits, data review, and follow-up) - Pre-study/site selection criteria and visit activities - Principal investigator oversight responsibilities - Project feasibility considerations - Roles of various clinical trial entities (e.g., CROs, sponsors, regulatory authority) - Site initiation and close-out activities - Site staff qualifications - Study close-out activities |
23 |
| Study and Site Management |
- Communication documentation requirements between all study entities - Content of contract and study budget - Equipment and supplies use and maintenance - Investigational product accountability and documentation requirements - Study staff training procedures and documentation requirements - Investigational product characteristics, labeling requirements, and packaging - Investigational product shipment - Investigational product storage - Non-compliance management - Project timelines (e.g., data lock, enrollment period, recruitment/retention) - Purpose of and process(es) for protocol compliance - Sample collection, processing, shipment, and storage requirements - Subject compliance assessment - Subject responsibilities for study participation and visit activities - Vendor management |
22 |
| Data Management and Informatics |
- Data management activities including data privacy 6B Elements and purposes of data collection tools (e.g., eCRF, EDC, IWRS blinding) - Elements of and process for data query - Reporting requirements for pharmacovigilance and/or product/device vigilance (e.g., CIOMS, IDMC/DSMB, safety databases) - Essential Documents for the conduct of a clinical trial (e.g., paper/electronic, trial master file) - Record retention, certified copy, and destruction practices and requirements - Source data review (SDR) and source data verification (SDV) purpose and process - Study documentation practices and requirements (Accurate, Legible, Complete, Original, Attributable, Contemporaneous, Consistent, Enduring, Available (ALCOA+)) |
15 |
The ACRP CCRC certification exam is designed to assess both theoretical knowledge and applied professional judgment in Flagship Certification. The exam evaluates competencies such as participant consent and safety management, protocol and site compliance, data collection and study documentation, ensuring candidates are prepared for real-world responsibilities as clinical research coordinators, study coordinators, research site operations professionals working in settings such as clinical trial investigator sites, academic medical centers, hospitals and healthcare research institutions.
To prepare effectively for the ACRP Certified Clinical Research Coordinator exam, candidates are encouraged to review official vendor materials, complete structured practice assessments, and gain hands-on experience relevant to their professional role.
