ACRP-MDP Certification Exam Syllabus
Welcome to the official MedicoExam syllabus guide for the ACRP Medical Device Professional certification. This page delivers a clear, structured overview of the ACRP-MDP exam, including key exam details, syllabus topics, and preparation references to support effective study planning. The ACRP Medical Device Professional (ACRP-MDP) is intended for professionals pursuing roles aligned with Specialty, with assessment centered on applied competencies such as medical device trial operations and site management, participant safety and device risk oversight, investigational device regulation and research design within real-world settings like medical device sponsors and manufacturers, contract research organizations, clinical research 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-MDP 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 medical device clinical research professionals, clinical operations professionals, regulatory and quality professionals
ACRP-MDP Exam Summary and Key Details
| Exam Name | ACRP Medical Device Professional |
| Credential | ACRP Medical Device Professional (ACRP-MDP) |
| Vendor | Association of Clinical Research Professionals (ACRP) |
| Exam Code | ACRP-MDP » ACRP-MDP Certification Practice Exam |
| Exam Delivery Mode | Computer-based testing at a PSI test center or through PSI live remote proctoring |
| Exam Duration | 90 mins |
| Number of Questions | 60 (50 Scored Items / 10 Pretest Items) |
| Passing Score | 600 (on a scaled of 200-800) |
| Exam Price |
ACRP Members – $250 Nonmembers – $300 |
| Scheduling Window | Two annual testing windows: February 15–May 15 and July 15–October 15 |
| Schedule Exam | ACRP |
| Trainings/Resources | ACRP Certification Exam Preparation Resources |
| Sample Questions | ACRP-MDP Exam Sample Questions |
| Recommended Practice | ACRP-MDP Certification Practice Exam |
ACRP-MDP Exam Syllabus Topics and Weighting
| Topic Areas | Topic Details, Courses, Books | Weighting |
|---|---|---|
| ETHICAL AND PARTICIPANT SAFETY CONSIDERATIONS |
- Review the safety and performance of the investigational product/device (e.g., using the instructions for use/IB) - Develop the informed consent form, and process for obtaining consent - Compare and contrast clinical care and clinical management of research participants (e.g., standard of care vs protocol requirements) - Identify and comply with the requirements for human subject protections and privacy under different national and international regulations and ensure their implementation throughout all phases of a clinical study - Identify safety risks related to device studies - Confirm the inclusion and exclusion criteria assure human subject protection - Evaluate and/or explain the benefits versus risks for study subject protection - Develop, maintain, and/or review unblinding procedures as applicable - Evaluate potential conflicts of interest - Manage device recalls, study holds, and safety alerts - Manage subject registries and long-term follow-up, continued access |
25% |
| INVESTIGATIONAL PRODUCT/DEVICE REGULATION | 10% | |
| CLINICAL TRIAL OPERATIONS (GCPS) |
- Evaluate the conduct and management of clinical trials within the context of applicable plans (e.g., protocol, study plan, monitoring plan, data management plan) - Review and/or document the process of appropriate control, storage, shipment, and dispensing of investigational products - Differentiate the types of adverse event, device effect, and device deficiencies that can occur during clinical trials, and their identification and reporting process - Comply with the safety reporting requirements of regulatory agencies both pre- and post-approval - Assess compliance and documentation of consent process - Verify continuity of medical care is provided for study subjects - Identify and/or manage adverse event, adverse device affects, and device deficiencies (e.g., treat subject, adjust treatment based on subject need and protocol) - Assess qualifications of the investigational site, site staff, and principal investigator - Develop or participate in protocol training - Develop or participate in investigational product/device training - Identify issues potentially requiring protocol amendments - Develop, update, and/or review the instructions for use/IB - Develop and/or utilize study device assessment tools (e.g., pacemaker interrogator) - Assess investigator/site/subject protocol compliance - Conduct initial risk assessment and ongoing risk assessment review - Oversee vendors (e.g., core labs, IRB/IEC, technology, subject recruitment, CRO) - Collect, maintain, verify, and/or store regulatory essential documents - Comply with randomization procedures of investigational product/device - Manage investigational product/device recall - Identify critical elements of an investigator agreement |
30% |
| STUDY AND SITE MANAGEMENT |
- Develop and/or manage resources necessary to conduct a study (the financial, timeline, and cross-disciplinary personnel) - Participate in and document the informed consent process(es) - Develop, review, and/or implement study plans and/or tools (e.g., subject materials, recruitment plan, lab manuals) - Evaluate reasons for subject discontinuation (e.g., causes, contact efforts) - Evaluate study for feasibility (e.g., site determining ability to successfully conduct the study) - Obtain and/or confirm presence of a signed indemnification/insurance, contracts, and/or budgets - Assess protocol compliance (visits, procedures, reporting) - Instruct subjects on protocol requirements and assess compliance (e.g., investigational product/device, diaries/logs, visits) - Perform and/or verify study device and diagnostic equipment calibration and maintenance - Verify appropriate staff, facility, supplies, and equipment availability throughout the study - Manage and/or review investigational product/device expiration and/or manage resupply or relabeling - Oversee device returns (e.g., unused returns, recalls, explant) - Manage device deficiency reporting - Record, and/or review data for accuracy and verifiability (e.g., device data transmitted directly, data collection devices) |
30% |
| SCIENTIFIC CONCEPTS AND RESEARCH DESIGN |
- Evaluate protocol for practicality of execution - Identify and/or implement risk management strategies (e.g., subject, investigational product/device, data handling) - Identify and/or describe study design |
5% |
The ACRP-MDP certification exam is designed to assess both theoretical knowledge and applied professional judgment in Specialty. The exam evaluates competencies such as medical device trial operations and site management, participant safety and device risk oversight, investigational device regulation and research design, ensuring candidates are prepared for real-world responsibilities as medical device clinical research professionals, clinical operations professionals, regulatory and quality professionals working in settings such as medical device sponsors and manufacturers, contract research organizations, clinical research sites.
To prepare effectively for the ACRP Medical Device Professional exam, candidates are encouraged to review official vendor materials, complete structured practice assessments, and gain hands-on experience relevant to their professional role.
