The CPI® (Certified Principal Investigator) credential is awarded to a PI (principal investigator) who has met eligibility requirements, demonstrated proficiency of specific knowledge and job‐related skills, and passed the standardized ACRP PI Certification exam.
The CPI® designation formally recognizes a PI has met the professional standards set forth by the Association of Clinical Research Professionals.
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 ACRP 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:
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.
ACRP’s certification exams are now aligned with the Clinical Trial Competency Framework, developed by the Joint Task Force for Clinical Trial Competency (JTF). The framework supports a growing movement toward defining professional competency in clinical research by using a universal set of standards.
Here’s what’s been recently updated:
These improvements are the result of a recent Job Analysis Survey to collect descriptive information about the tasks performed by clinical researchers and the knowledge, skills, or abilities requisite to job competence in the field.
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:
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 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. 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.
Exam results provide important feedback about one’s performance in each of the six (6) 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.
The total cost to apply includes an Exam fee and Application fee as follows:
Early-Bird Application Dates: May 1 – June 15, 2018
ACRP Member Rate
Application Fee: $135
Exam Fee: $300
Application Fee: $135
Exam Fee: $350
Regular Application Dates: June 16 – August 17, 2018
ACRP Member Rate
Application Fee: $135
Exam Fee: $325
Application Fee: $200
Exam Fee: $400
Should an applicant not be eligible to take the exam or need to cancel within a reasonable time frame, the exam fee is refundable. The application fee ($135/$200) is non-refundable regardless of eligibility status or cancellation. Credit card, check, or bank transfers are acceptable forms of payment.
Before you apply, login to acrpnet.org to verify your ACRP Membership status and confirm the total payment due at time of application.
The CPI® eligibility criteria define the minimum experience required before a PI can apply for the program. It is important to compare the CPI® eligibility criteria with your experience to self-determine your eligibility before submitting an application and payment. All applications must undergo a formal review process to determine an applicant’s eligibility to sit for the exam.
In order to be deemed eligible to take the CPI® exam, applicants for the CPI® credential must be able to provide evidence through a job description, detailed CV or other documentation that they:
The PI Certification Handbook has complete employment definitions.
Update: The CPI Exam is the first exam being offered to all investigators with a doctoral-level degree. A license to practice medicine is no longer required.
As defined by the ACRP, and determined through ACRP’s 2015 Job Analysis Survey, principal investigators who are eligible for PI Certification must document performance of the essential PI duties using a job description for each relevant position held during the dates of employment listed on the application. The essential PI duties are as follows:
The eligibility requirement options below should be met before applying for the CPI® program.
For at least two (2) of the most recent five (5) years*:
Applicants must submit a detailed résumé or CV and a job description with the exam application. This must include a description of the candidate’s PI job functions and specific employment dates. Do not include a list of study participation with your CV.
Any proprietary details may be blocked out.
Applicants may utilize one option below as a valid substitute. Under no circumstance will an applicant be permitted to use more than one substitution for the same application.
ACRP acknowledges that there is a shared knowledge base between CCRA and CRC designation holders and those who seek the CPI designation. Any candidate for the CPI designation who has a current CCRA or CCRC designation will have achieved a valid substitute for 1,500 hours of the required professional experience performing the essential duties of a CPI.
ACRP permits applicants who have completed a clinical research degree program that meets specific standards to be used as a substitute for one (1) of the two (2) required years of employment as a principal investigator.
For requirements and details, view the PI Handbook (Clinical Research Degree Programs- Substitution for Work Experience Requirements section).
The eligibility review process includes determining completeness of the application and determining whether or not the applicant meets the eligibility criteria for the exam. This process begins within one week of receiving the application and may take up to two weeks to review before any update is emailed.
It is not unusual for an applicant to receive a request for additional and/or clarifying information from an Eligibility Reviewer. These requests will come via e-mail. Applicants will have seven (7) calendar days to respond to the request. Applicants who do not respond to the request for additional or clarifying information will automatically have their applications determined incomplete and therefore are ineligible to take the exam. Ineligible applicants will be refunded the exam fee only.
If an applicant is determined to be eligible after the application has been reviewed, the candidate will be e-mailed an Eligibility Notice, with further instructions as to how to schedule his/her exam appointment.
Note: check your SPAM or Junk mail folder if you do not receive any notice within 14 days of applying.
If an applicant is determined to be ineligible during initial review, the application is automatically reviewed by a second reviewer. If the second reviewer also determines the applicant to be ineligible, the applicant is automatically found ineligible and will be refunded the exam fee. Applicants are notified via e-mail at each step of the review with an explanation of the deficiency identified.
If a third-level review is necessary the final determination will be made by the Certification Director. If the application is deemed ineligible, he/she can choose to appeal to the Academy Board of Trustees.
Applicants found to be ineligible who do not initiate the Appeals process within the stipulated timeframe will automatically be refunded the exam fee.
See the PI Certification Handbook for complete details of the Eligibility Review Process.
After determining that you meet the eligibility requirements, you must submit together the application, supporting documents, and full payment for a complete application.
ACRP offers a one-time transfer from the current exam offering to the next for a $50 fee. There are two situations in which candidates may take advantage of this:
Transfers are applied toward the next exam only. Transfer of eligibility and associated fees will be applied only to the original candidate and are not transferable to another person, even if paid for by a third party. Exam fees are transferred toward the next exam only and not toward other products or services.
If you choose to transfer to the next exam window for one of the two reasons above, you must submit a request to transfer before the end of the exam window for which you had originally applied. To submit a transfer request, you must access your online application and select Request Exam Window Transfer.
If you have an exam appointment scheduled, you must first cancel it directly with Prometric before submitting your online request to transfer to the next exam window. Fees, payable to Prometric directly, apply for appointment cancellations made within thirty (30) to five (5) days prior to an appointment date and do not include transfer fees paid to ACRP. Cancellations are not permitted less than five (5) days prior to an appointment.
If a transfer candidate does not submit the request before the end of the current exam testing window, then all funds originally submitted will be forfeited. Transferring is not an option for re-examination candidates (from the previous exam cycle).
When a transfer request has been approved, all fees (application and exam fees) are applied automatically at the start of the next application period. All eligible transfer candidates will receive an email notice of Eligibility when the Eligibility ID has been reactivated and an exam appointment can be scheduled. Contact firstname.lastname@example.org if you did not receive your new Eligibility Notice. Candidates who are required to submit documentation for subsequent eligibility review must do so at the start of the next application period.
View full policy on transfers, cancellation, no shows, refunds and re-examination.
If a candidate must cancel an exam, the only portion of the total amount submitted that will be refunded is the exam fee, provided that the request for cancellation is received at least five (5) calendar days prior to a scheduled exam appointment. Application fees are nonrefundable. Cancellation requests received after that time will not be honored. Refunds are not available to candidates who do not schedule or attend the exam. Refund requests will be accepted only if made by the candidate.
Applicants who do not meet the eligibility requirements for the exam (i.e., those who are ineligible), or who are ineligible due to an incomplete application, will receive a refund of the exam fee only, within three weeks of the final ineligibility notification.
Refund requests can be made by the candidate only. Employers supporting a candidate’s fees cannot request or receive a refund for fees paid to ACRP. Any refund will be sent to the party who initially paid for the exam. If payment was made by credit card, that card will receive the credit. If the payment was made by check, ACRP will mail a refund check to the original payer.
Contact email@example.com for any other refund inquiries.
Only applications received with required supporting documentation and full payment will be accepted. View the PI Certification Handbook for complete details, or View the Application Checklist for helpful tips.
Online Application (Recommended)
Payment Options: Credit Card Only
You will receive an automatic email confirmation upon submission of application and the following documents:
Upload documents as part of the online application.
(Application link will be under “My Account Links” after signing in with your ACRP account).
Payment Options: Check or Bank/Wire Transfer
You will receive an email confirmation within 10 business days upon receipt of emailed, faxed, or mailed applications and the following documents:
Email, fax, or mail documents with application.
All applications undergo a thorough eligibility review process. A second email confirms that the application was received by ACRP and is being prepared for the Eligibility Review process. Please allow up to 10 days to receive your eligibility email notification.
Rescheduling or canceling an exam appointment (test center location, date, or time) is permitted by Prometric up to five (5) days before your scheduled appointment. There may be fees associated with appointment changes. Rescheduling availability varies, depending on the test center location, and number of days prior to the exam appointment date.
If you do not plan to take the exam during the current exam window, you must cancel your exam appointment and submit the following request:
Your request must be received by ACRP at firstname.lastname@example.org within the time specified or all fees paid will be forfeited.
1. Obtain Eligibility ID Number
2. Make Your Appointment
3. Keep Your Appointment Confirmation
Exams are scheduled through Prometric, ACRP’s testing partner, and may be taken at approximately 600 testing centers internationally. Only candidates determined to be eligible will receive an Eligibility Notice immediately following the Eligibility Review process.
This important notice includes a Prometric ID number, the Prometric Exam Scheduling web address, and instructions for scheduling a personal exam appointment. Candidates select the testing center, exam date, and time on a first-come, first-served basis.
For detailed assistance with selecting your test center, view Exam Sites.
Services for People with Disabilities: For questions regarding accommodation, view the Policy on Special Accommodations and Request Form.
Rescheduling or cancelling your exam appointment (test center location, date, or time) is permitted by Prometric up to five (5) days before your scheduled appointment. Appointments may only be rescheduled within the same exam window. Fees are associated with appointment changes. If you need to cancel, and do not plan to reschedule an exam appointment, you may be eligible for a refund. Rescheduling or cancelling is not permitted within four (4) days of an appointment.
To reschedule, cancel, or transfer find full details (contact information, deadlines, fees, and requests forms) in the PI Certification Handbook.
If a candidate will be unable to keep his/her exam appointment due to an emergency situation that arises within five (5) days prior to his/her exam date, the candidate is required to submit an Emergency Cancellation Form and official documentation to ACRP at email@example.com. This information must be received up to seven (7) calendar days after the candidate’s scheduled exam date. The following situations will be considered with documentation:
There are strict requirements for arrival, identification, available resources, exam security, and behavior during the exam. It is the exam candidate’s responsibility to be aware of the test center regulations and required behavior.
For full details, view the PI Certification Handbook (Section: Taking the Exam).
Become familiar with the following before you go:
For more Test Center FAQs, view Prometric’s Test Regulations.
The best preparation for ACRP Certification exams is understanding the knowledge requirements of your role and their application to clinical research.
ACRP recommends that you first understand the scope of the exam content by carefully reviewing its Detailed Content Outline and becoming familiar with the references (ICH Guidelines and Declaration of Helsinki).
No two candidates come to the exam with the same knowledge base. Since experience and educational backgrounds are unique, these differences must be taken into consideration when determining a study method. Begin to prepare using the following steps:
Step 1: Assess your own professional experience. Read carefully through the Detailed Content Outline description for the exam you wish to take. Each exam (CRC, CRA, PI) has a different DCO. Compare the detailed description of knowledge and tasks, plus the proportion of questions, to your own professional experience. Rate your relative skill level and experience on a scale of 0–5 (0 = no experience) as an indicator of how prepared you are for each section and where to invest more of your study focus in preparing for the exam.
While you personally may have limited experience with certain job functions due to your job description with your employer, success on the exam requires you to demonstrate competency in all areas of the exam.
Step 2: Start early and plan ahead. Don’t wait to receive your Eligibility Notice. You must complete and submit your detailed application at least three (3) weeks before the exam. Don’t leave this until the last minute! Focus some learning time on reading in every content category, but spend extra time reading in those categories where your experience is limited. Match your study efforts in relation to the time you have available and the specific study needs you have identified for yourself. Every exam candidate will answer the same number of questions in every category.
Step 3: Schedule your study time. If you decide to set up a study group, you should hold weekly meetings that will take about two hours on one day/evening every week. Schedule flexible blocks of time into your personal schedule. The key is not to memorize what you read, but to understand concepts behind ICH/GCP and best practices in each knowledge category area to supplement your experience. Be sure you understand how your SOPs differ in relation to ICH/GCP.
Step 4: Organize your study notes. It may help you to organize your study notes, articles, summaries, etc. in a binder using either the five (5) exam categories, or your own index. Let your experience guide you in the content areas you are most comfortable with and focus more time in your weaker areas or on those areas with which you are least familiar. Create flashcards to use as study aids.
Step 5: Choose the methods that are right for your study plan. Choose a mentor or colleague who has more experience in the areas in which you are less familiar and ask him/her to review concepts with you. As you perform your daily responsibilities, think about the underlying principles that lead you to take a particular course of action. This will help you connect ICH/GCP to your daily work.
Step 6: Stick to your study group’s plan. Pick a regular night and show up on time. Each of you has the same goal, and everyone has something to offer. Sharing reading and exchanging notes is a great way to lighten the load. Study groups foster friendships and provide an incentive to stay focused on your collective goal. Complete; don’t compete.
Step 7: Don’t panic. Follow the excellent pre-exam advice that ACRP provides, and come to the exam well-rested and prepared.
In addition to reviewing the ICH Guidelines, one way to review is to select texts and training materials you used when first taking on the role of a CRA, CRC or PI. You can select a publication that you may already have on your bookshelf, or one that you can borrow from a colleague. You should select books or publications that cover topics found on the Detailed Content Outline, the ICH Guidelines, or the tenets of GCP, but do not focus on specific (i.e., FDA) regulations.
If you have time, take a workshop or attend a conference session on topics in which you need to become more familiar. Any professional development courses that cover clinical research topics will add to your knowledge base and therefore will help you prepare for the exam.
NOTE: ACRP does not sponsor or endorse any specific educational courses—even if the course is advertised as a “prep” or “review” course for the ACRP Certification Exams. Courses titled this way are at the discretion of the organization offering the course. Those creating the course have not had any inside information about the exam. The same information that is included in this Handbook to help you prepare is publicly available to those creating educational content. Participation in these courses may help you learn or review topics covered on the exam, but you should not expect them to directly cover exam content.
Most adults haven’t taken a standardized exam recently. It can be helpful to be reminded of some key strategies for how to approach a multiple-choice exam:
ACRP offers a variety of resources to help you study and prepare for your ACRP Certification exam, including practice exercises, eLearning programs, apps, and more.
Upon completion of your computer based examination, you will receive your test results via email. A pass/fail score is generated based on your overall performance on the examination.
The passing score is set by a panel of subject matter experts representative of the professional. These experts review each test question, evaluate the difficulty of the questions, and make a judgement as to how a candidate with basic proficiency would perform on the question. The judgements are analyzed statistically to determine the passing score.
The passing scaled score for the exam is 600. A candidate scoring below 600 has not been successful on the exam and cannot be certified.
The number of questions answered correctly (or total points) is a candidate’s “raw score”. Prometric then converts a candidate’s raw score to a scaled score. The “Total Scaled Score” will determine whether a candidate has passed the exam. The exam is not scored on a curve and there is no predetermined number of candidates permitted to pass.
ACRP Certification is the premier mark of excellence in the clinical research field. View the benefits of certification to see what it can do for you and your organization.
Browse our index of important resources, including Certification forms, web pages, references, policies, and other helpful materials for earning your ACRP Certification.