ACRP-MDP study guide
ACRP-MDP · Work through your exam, one topic at a time.
The ACRP-MDP® (ACRP Medical Device Professional) is a specialty credential from the Association of Clinical Research Professionals that formally recognizes clinical research professionals with specialized knowledge in medical device clinical trials. It is aimed at practitioners who already hold an ACRP certification - CCRC®, CPI®, ACRP-CP®, or CCRA® - and want to demonstrate device-specific competence on top of their core credential. The exam consists of 60 multiple choice questions that must be answered within 90 minutes, and it is referenced to the ICH Guidelines and to ISO 14155:2026. Content is organized around core knowledge areas described in the ACRP-MDP Exam Content Outline, which candidates should read first to identify where to focus study time. Topics on this exam: Medical device clinical research core knowledge areas (per ACRP-MDP Exam Content Outline) and ICH and ISO 14155:2026-referenced medical device trial conduct (per ACRP-MDP Exam Content Outline). The ACRP-MDP study guide has 2 sections and about 750 words.
01Medical Device Clinical Research Core Knowledge Areas
Medical device trials differ from drug trials in ways that drive most of the questions. Devices are often iterative, modified during development, and evaluated for safety and performance rather than efficacy alone. Know the vocabulary: intended use (the general purpose for which the device is intended, per labeling) versus indications for use (the specific disease/condition, population, and anatomical site). Confusing these is a classic trap-intended use is broad; indications are narrow.
399 words, about 2 min02ICH and ISO 14155-Referenced Medical Device Trial Conduct
ISO 14155 (Good Clinical Practice for clinical investigations of medical devices) is the backbone, harmonized with ICH E6 GCP principles. Know that ISO 14155 addresses the sponsor, monitor, investigator, and ethics committee roles, plus the CIP, informed consent, and documentation. ICH E6 supplies overarching GCP principles (ethics, data quality, traceability). Expect questions testing which party owns which obligation.
351 words, about 2 min