ACRP CCRA Certification Exam Syllabus
Welcome to the official MedicoExam syllabus guide for the ACRP Certified Clinical Research Associate certification. This page delivers a clear, structured overview of the ACRP CCRA exam, including key exam details, syllabus topics, and preparation references to support effective study planning. The ACRP Certified Clinical Research Associate (CCRA) is intended for professionals pursuing roles aligned with Flagship Certification, with assessment centered on applied competencies such as Clinical trial monitoring and oversight, participant protection and ICH GCP compliance, site management and data quality within real-world settings like Sponsor organizations, contract research organizations, clinical trial sites.
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 CCRA 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 associates, clinical trial monitors, sponsor and CRO research professionals
ACRP CCRA Exam Summary and Key Details
| Exam Name | ACRP Certified Clinical Research Associate |
| Credential | ACRP Certified Clinical Research Associate (CCRA) |
| Vendor | Association of Clinical Research Professionals (ACRP) |
| Exam Code | CCRA » ACRP CCRA Certification Practice Exam |
| Exam Delivery Mode | Computer-based testing at PSI test centers or through 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 | 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 CCRA Exam Sample Questions |
| Recommended Practice | ACRP CCRA Certification Practice Exam |
ACRP CCRA 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 (instructions for use) - Rationale for participant eligibility requirements - Rationale for trial design - Study design characteristics (e.g., double-blind, crossover, randomized) - Study objective(s) and end points/outcomes - Use of comparator or control product in study design - Treatment assignments (e.g., randomization, open label, registries) - Stages of product development |
12 |
| Ethical and Participant Safety Considerations |
- Adverse events definitions/classification, documentation, and reporting (e.g., SAE, AESI, SUSAR) - Blinding/unblinding procedures - Elements of eligibility required by IRB/IEC - Confidentiality and privacy requirements - Risks and benefits of the safety profile - Elements of the informed consent - Informed consent process requirements - Protection of human subjects (e.g., IRB/IEC requirements, Declaration of Helsinki, participant compensation) - Protocol deviation/violation identification, documentation, and reporting processes - Recruitment and retention plan/strategies - Safety monitoring - Participant discontinuation criteria/procedures - Vulnerable participant populations - Conflicts of interest in clinical research (e.g., financial for PI or staff, family and site participation in trial) - Elements of potential fraud and misconduct |
18 |
| Regulatory Requirements |
- IRB/IEC reporting requirements and communication - IRB/IEC purpose, role, and composition - Protocol and protocol amendment submission and approval processes - Regulatory authority reporting requirements and communication (e.g., safety, CSR) |
14 |
| Clinical Trial Operations (GCP) |
- Elements of an effective root cause analysis and corrective and preventive action (CAPA) plan - Elements of and rationale for monitoring plan(s) - Monitoring responsibilities (e.g., purpose, extent, procedures) - Principal investigator responsibilities - Principles of risk-based monitoring/data governance - Project feasibility considerations - Responsibilities of various clinical trial entities/personnel (e.g., CROs, sponsors, regulatory authority, data manager) - Audits and inspection processes (preparation, participation, documentation, and follow-up) - Pre-study and site selection activities |
18 |
| Study and Site Management Activities |
- Communication documentation requirements (e.g., phone, email) - Equipment and supplies use and maintenance - Investigational product/device management (e.g., accountability, dispensing shipment, storage, labeling, and documentation requirements) - Processes and management of non-compliance (e.g., IRB, GCP, CFR, protocol) - Roles of various clinical trial entities/plan (e.g., medical monitor, vendors, IRB/IEC, sponsor, CRO) - Sample/diagnostic collection, shipment, verification, reporting, and storage requirements (e.g., lab, imaging, raters) - Participant compliance and responsibilities for study participation - Contracts and budgets (e.g., participant compensation, site payments) - Management of study site documentation (e.g., ISF/TMF reconciliation) - Delegation, qualification, and training of appropriate responsibilities at site - Site initiation activities - Interim visit activities - Site close-out activities - Essential document requirements (e.g., Trial Master File, Investigator Site File) |
25 |
| Data Quality |
- Data privacy principles and access to site/participant records (e.g., paper vs. EMR) - Elements and purposes of data collection tools (e.g., CRF/eCRF, patient reported outcome devices) - Elements of and process for data query (e.g., query writing) - Purpose of pharmacovigilance (e.g., CIOMS, IDMC/DSMB, safety databases) - Record retention and destruction practices and requirements - Source data review (SDR) and source data verification (SDV) purpose and process - Source documentation requirements and GDP (e.g., ALCOA+) - Critical variables and critical processes - Impact of efficacy and safety (e.g., interim analysis result, DSMB review) |
13 |
The ACRP CCRA certification exam is designed to assess both theoretical knowledge and applied professional judgment in Flagship Certification. The exam evaluates competencies such as Clinical trial monitoring and oversight, participant protection and ICH GCP compliance, site management and data quality, ensuring candidates are prepared for real-world responsibilities as Clinical research associates, clinical trial monitors, sponsor and CRO research professionals working in settings such as Sponsor organizations, contract research organizations, clinical trial sites.
To prepare effectively for the ACRP Certified Clinical Research Associate exam, candidates are encouraged to review official vendor materials, complete structured practice assessments, and gain hands-on experience relevant to their professional role.
