What is a PI?
A PI serves as the principal investigator and accepts responsibility for the safe and ethical conduct of a clinical trial.
Am I Eligible to Become a CPI®?
In order to achieve CPI® Certification, all applicants must meet the eligibility requirements and pass the written PI Certification Exam. The applicant should determine his/her own eligibility before submitting an application to the program.
Explore the ‘Eligibility for Your Exam’ tab below to review full eligibility requirements.
The exam content is based on current practice in clinical research and was determined by an international job analysis.
The exam is referenced to the International Conference on Harmonization (ICH) Guidelines. Other than the ICH Guidelines, no other regulatory framework is tested.
The exam assesses your proficiency of the body of knowledge required and the application of that knowledge in the conduct of your job duties and responsibilities.
To earn CPI® Certification, professionals are expected to have proficiency in six (6) core knowledge areas found below and detailed further in the Detailed Content Outline (DCO) for their respective exam:
- Scientific Concepts and Research Design
- Ethical and Participant Safety Considerations
- Product Development and Regulation
- Clinical Trial Operations (GCPs)
- Study and Site Management
- Data Management and Informatics
Each question on the exam is based on this outline; therefore, one should study this outline and especially consider the underlying knowledge, skills, and abilities needed to perform as a CRA, CRC, or PI, to prepare for the exam.
Handbook & Detailed Content Outline
ACRP CERTIFICATION EXAM HANDBOOK
CPI EXAM DCO
The exam is referenced to the International Conference on Harmonization (ICH) Guidelines. Other than the ICH Guidelines, no other regulatory framework is tested. The exam does not cover country-specific (FDA, EMA, etc.) regulations.
The exam does not test how you or your employer carries out those duties. The exam tests your knowledge and application of that knowledge, which is required to perform in your role safely and effectively. The following are the only references for which the ACRP Certification exam content can be supported:
- 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, and
- The Declaration of Helsinki (DoH).
Also available at the official webpages for the ICH Guidelines and the Declaration of Helsinki.
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.
How Are Exams Developed?
To learn more about how the DCOs and exams are developed, visit How Are Certification Exams Developed? and view the ACRP Certification Handbook.
The exam consists of 125 multiple-choice questions (25 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 expert peer review, performed by the Global Certification Exam Committees. 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 three (3) hours to complete the 125 questions. Questions can be skipped, marked for review, and returned to at any time prior to submitting the exam for scoring. Results are provided upon the conclusion of the exam.
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.