ACRP-PM Certification Exam Syllabus
Welcome to the official MedicoExam syllabus guide for the ACRP Project Manager certification. This page delivers a clear, structured overview of the ACRP-PM exam, including key exam details, syllabus topics, and preparation references to support effective study planning. The ACRP Project Manager (ACRP-PM) is intended for professionals pursuing roles aligned with Specialty, with assessment centered on applied competencies such as clinical study planning and oversight, trial operations and quality management, budget resource and stakeholder management within real-world settings like pharmaceutical and biotechnology sponsors, contract research organizations, academic medical centers and 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-PM 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 project management professionals, clinical trial operations managers, research program managers and related roles
ACRP-PM Exam Summary and Key Details
| Exam Name | ACRP Project Manager |
| Credential | ACRP Project Manager (ACRP-PM) |
| Vendor | Association of Clinical Research Professionals (ACRP) |
| Exam Code | ACRP-PM » ACRP-PM Certification Practice Exam |
| Exam Delivery Mode | PSI in-person test center or remotely proctored online examination |
| 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 | 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-PM Exam Sample Questions |
| Recommended Practice | ACRP-PM Certification Practice Exam |
ACRP-PM Exam Syllabus Topics and Weighting
| Topic Areas | Topic Details, Courses, Books | Weighting |
|---|---|---|
| ETHICAL AND PARTICIPANT SAFETY CONSIDERATIONS |
- Develop and/or review informed consent form. - Oversee compliance 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. - Collect and/review information about potential conflicts of interest. |
10% |
| REGULATORY AFFAIRS |
- Oversee compliance with the regulatory requirements that are applicable for investigational product/device development and/or research protocol. - Manage budgetary and logistical aspects of investigational product/device accountability |
10% |
| CLINICAL TRIAL OPERATIONS |
- Evaluate the conduct and management of clinical trials within the context of applicable plans (e.g., protocol, study plan, monitoring plan, data management plan). - Participate in audits and inspections (e.g. prepare, support, respond). - Coordinate and oversee protocol, protocol amendments, and other relevant documents through appropriate approval processes (e.g., IRB/IEC, sponsor, regulatory authority). - Develop or participate in protocol and study training (e.g., site initiation visit, investigator meeting, webinar). - Identify issues potentially requiring protocol amendments. - Develop and/or utilize study management tools. - Create, document, and/or implement corrective and preventive action (CAPA). - Integrate a risk-based approach to quality management (e.g. risk assessment). - Escalate significant issues as appropriate. - Prepare, support and/or participate in close-out activities (site or study). - Oversee vendors (e.g., labs, IRB/IEC, technology, subject recruitment, CRO). - Oversee the collection, maintenance, verification, and/or storage of regulatory essential documents. - Manage investigational product/device recall process. - Oversee and approve initial shipment of investigational product to site. |
25% |
| STUDY MANAGEMENT |
- Develop and/or manage resources necessary to conduct a study (e.g., the financial, timeline, and cross-disciplinary personnel. - Oversee quality control activities in the conduct of clinical research. - Continually evaluate subject recruitment strategy and study programs. - Manage staff to performance metrics. - Develop, review, and/or implement study plans and/or tools (e.g., subject materials, recruitment plan, lab manuals). - Manage the protocol amendments process. - Obtain and/or confirm presence of a signed indemnification/insurance, contracts, and/or budgets. - Assess protocol compliance (visits, procedures, reporting). - Manage and/or review investigative product/device expiration and/or manage resupply or relabeling. - Oversee and manage the study contract process. - Develop and/or negotiate study budget. |
30% |
| SCIENTIFIC CONCEPTS AND RESEARCH DESIGN |
- Review the protocol and supporting documentation (e.g., investigators brochure, instructions for use, package insert). - Identify and/or describe study design. - Identify and/or describe study hypothesis for investigator-initiated trials. |
10% |
| BUSINESS MANAGEMENT, LEADERSHIP, AND PROFESSIONALISM |
- Apply the principles and practices of leadership, management, and mentorship within the working environment - Lead culturally diverse teams |
15% |
The ACRP-PM certification exam is designed to assess both theoretical knowledge and applied professional judgment in Specialty. The exam evaluates competencies such as clinical study planning and oversight, trial operations and quality management, budget resource and stakeholder management, ensuring candidates are prepared for real-world responsibilities as clinical research project management professionals, clinical trial operations managers, research program managers and related roles working in settings such as pharmaceutical and biotechnology sponsors, contract research organizations, academic medical centers and research sites.
To prepare effectively for the ACRP Project Manager exam, candidates are encouraged to review official vendor materials, complete structured practice assessments, and gain hands-on experience relevant to their professional role.
