How is ACRP-MDP® Different from Other ACRP Certifications?
The ACRP-MDP Subspecialty Designation does not replace any of the other ACRP certifications. The CCRA®, CCRC®, ACRP-CP®, and CPI® programs are based on the body of knowledge needed to demonstrate the competence of a clinical research professional. Those seeking the ACRP-MDP must first pass one of these certification exams. Those who pass the ACRP-MDP have demonstrated the specific knowledge related to medical devices in clinical research.
By earning the ACRP-MDP subspecialty, professionals of all types show they have not only earned a flagship certification in clinical research through ACRP, but have also demonstrated knowledge in clinical research project management.
The Medical Device Professional Subspecialty Designation exam is referenced only to the International Conference on Harmonization (ICH) Guidelines. The exam assesses your proficiency in medical devices related to clinical research.
To earn an ACRP Subspecialty designation, professionals are expected to have proficiency in a number of core knowledge areas. These specific areas are explained in the Detailed Content Outline (DCO) for this exam.
Detailed Content Outline
- Guideline for Good Clinical Practice E6(R2)
- Definitions and Standards for Expedited Reporting E2A
- General Considerations for Clinical Trials E8
- Statistical Principles for Clinical Trials E9
- Clinical Trials in Pediatric Population E11
- The Declaration of Helsinki (DoH), And
- ISO 14155:2011 (International Organization for Standardization)
Also available at the official webpages for the ICH Guidelines, the Declaration of Helsinki, and International Organization for Standardization.
Exam Abbreviation List
The Abbreviations List provides the full wording for abbreviations used on the exam. The list is accessible on each screen during the exam.
The exam consists of 60 multiple-choice questions (10 of these questions are pre-test items and do not affect a candidate’s score. These items are not identified to candidates).
Candidates are presented with a question and are asked to choose the single best answer from the four options provided. Only one answer is correct.
The questions test knowledge at the recall, application, and analysis level, not just a recitation of facts. Some questions use hypothetical scenarios.
The exam content is based on a process of peer review by subject matter experts. There are no “trick” questions on the exam, and there is no penalty for guessing.
The exams are administered at computer terminals at secure testing centers or online via remote proctoring. Each candidate is provided a brief tutorial on navigating the exam prior to the official start time. Each candidate is allowed a maximum of 90 minutes to complete the 60 questions. Questions can be skipped, marked for review, and returned to at any time prior to submitting the exam for scoring.
Exam results provide important feedback about one’s performance in each of the five (5) content areas of the exam. Understanding how the exams are scored is important for interpreting the results.
The Exam is provided in English.
Exam candidates may bring a hard-copy (Electronic dictionaries are not permitted) English-German/ Spanish/ Chinese/ Hindi/ etc. translation only (word-to-word) dictionary to the exam. Dictionaries containing any word definitions or other extraneous markings are strictly prohibited. The dictionary will be inspected by the proctor prior to and after the exam is completed. Any attempt to compromise the exam will be grounds for immediate dismissal from the site, invalidation of the exam score, and possible legal action. No additional time is given to those using a translation dictionary.
ACRP and the Academy shall not discriminate against any member, certificant, or individual applying for membership or certification on the basis of gender, race, color, national origin, sex, age, religion, marital status, sexual orientation, political affiliation, citizenship status, physical challenge, disability, veteran status or any other status or condition that is protected by applicable law.