ACRP-CP Exam Format | Course Contents | Outline | Syllabus | Objectives

ACRP-CP Exam Syllabus & Study Guide

Before you start practicing with our exam simulator, it is essential to understand the official ACRP-CP exam objectives. This course outline serves as your roadmap.

The information below reflects the 2026 syllabus defined by ACRP.

Below are complete topics detail with latest syllabus and course outline, that will help you good knowledge about exam objectives and topics that you have to prepare. These contents are covered in questions and answers pool of exam.

Association of Clinical Research Professionals – Certified Professional (ACRP-CP) I. Ethical and Participant Safety Considerations (19%) II. Investigational Product/Device Regulation (16%) III. Clinical Trial Operations (GCPs) (25%) IV. Study and Site Management (23%) V. Scientific Concepts and Research Design (8%) VI. Data Management and Informatics (9%) Total 100% I. Ethical and Participant Safety Considerations - Clinical care and clinical management of research participants - Clinical equipoise and therapeutic misconception as related to the conduct of a clinical trial - Requirements for human subject protections and privacy - Principles and content of the key documents ensuring the protection of human participants in clinical research - Ethical issues involved when dealing with vulnerable populations and the need for additional safeguards - Past and current ethical issues, and cultural variations as they apply to the clinical development process - Why inclusion and exclusion criteria are included in a clinical protocol to assure human subject protection - Principles and methods of risk versus benefit through selection and management of clinical trial subjects - Adverse events classification, documentation, and reporting - Blinding procedures - Components of subject eligibility requirements - Confidentiality and privacy requirements - Elements of the Investigator Brochure - Elements of the informed consent form - Informed consent/assent process requirements - Protocol deviation/violation identification, documentation, and reporting process - Recruitment plan/strategies - Safety monitoring - Subject discontinuation criteria/procedures - Subject retention strategies - Subject safety and privacy issue management - Conflicts of interest in clinical research II. Investigational Product/Device Regulation - Roles and responsibilities of the various stakeholders and regulatory institutions in clinical trials - Legislative and regulatory framework supporting the development and registration of medicines, devices, and biologics - Specific processes and phases required for regulatory approval of marketing authorization - Regulatory reporting requirements (e.g., pre- and post-approval, safety) - Standards for handling hazardous goods, materials, and biological samples (e.g., IATA) - Audit and inspection processes (preparation, participation, documentation, and follow-up) - Clinical trial registries and requirements - What constitutes fraud and misconduct - IRB/IEC reporting requirements - IRB/IEC role, composition, and purpose - Protocol and protocol amendment submission and approval processes - Significant milestones in the evaluation of efficacy and safety (e.g., interim analysis, DSMB review) III. Clinical Trial Operations (GCPs) - Conduct and management of clinical trials within the context of applicable plans - Roles and responsibilities of the clinical investigation team as defined by GCP - Design, conduct, and documentation of clinical trials required for GCP compliance - Protocol-required control, storage, and dispensation of investigational products/devices - Adverse events occurring during clinical trials, including identification of AEs, SAEs, and ADRs - Regulations and guidelines assuring human subject protection and privacy - Reporting requirements relating to clinical trial conduct - Processes and purposes for monitoring the study - Purpose and process of clinical trial audits and inspections - Identification, management, and reporting requirements for protocol/GCP deviations/violations - IRB/IEC requirements for submission, review, and approval of documents - Delegation of responsibilities - Elements of an effective corrective and preventive action (CAPA) - Purpose and use of the Investigator Brochure - Requirements of indemnification/insurance - Source data review (SDR) and source data verification (SDV) - Site selection activities - Principal investigator responsibilities - Project feasibility considerations - Roles of various clinical trial entities (e.g., CROs, sponsors, regulatory authorities) - Site initiation activities - Site and study close-out activities - Study personnel training and qualification requirements IV. Study and Site Management - Quality management activities in the conduct of clinical research - Resources necessary to conduct a study - Methods used to track subject recruitment and study progress - Responsibilities and obligations involved in the conduct of a clinical trial - Procedures, documentation, and oversight requirements of PIs, sponsors, CROs, and regulatory authorities - How to assess, manage, and report adverse event causality, severity, and relationship to investigational product/device - Communication documentation requirements - Contractual agreements - Corrective and preventive action (CAPA) processes - Maintenance and use of equipment and supplies - Investigational product/device accountability and documentation requirements - Investigational product/device use - Investigational product/device reference materials - Investigational product/device storage and disposition - Non-compliance management - Sample collection, storage, disposal, and shipment requirements - How to assess subject compliance - Subject responsibilities for study participation - Subject visit activities - Vendor management - Principal investigator oversight requirements - Identification and reporting requirements for protocol deviations/violations - Study evaluation for feasibility - Reviewing and interpreting values for lab and test results - Subject discontinuation process - Protocol and protocol amendment implementation process V. Scientific Concepts and Research Design - Clinical trial design - Elements of a protocol - Elements of an Investigator Brochure (IB) and/or investigational device instructions for use - Rationale for subject eligibility requirements - Rationale for complying with and consequences of noncompliance with a protocol - Risk management strategies and principles - Study objectives, hypotheses, and endpoints/outcomes - Treatment assignments (e.g., randomization, open-label, registries) VI. Data Management and Informatics - Basic concepts of biostatistics and informatics in research - Flow of data throughout a clinical trial - Process of electronic data capture - Requirements for data collection, correction, and queries - Data quality systems - Data privacy principles - Purpose of pharmacovigilance - Essential documents for the conduct of a clinical trial - Record retention and destruction practices and requirements - Source data/document review (SDR) and source data verification (SDV) - Study documentation practices (ALCOA-C) - Principal investigator responsibility to make all source records available for monitoring, auditing, and inspection