The Association of Clinical Research Professionals

PI Certification

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 Academy of Clinical Research Professionals.

What is a PI?

A PI (principal investigator) holds a doctoral-level degree (PhD, PharmD, DNP, DO, MD, DDS or equivalent degree) and serves as the principal, sub- or co- investigator; or monitors, supervises, or designs clinical trials; and accepts responsibility for the safe and ethical conduct of a clinical trial.

Am I Eligible to Become a CPI®?

In order to achieve ACRP Certification, all applicants must meet the eligibility requirements and pass the written ACRP CPI 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.

About the Exam

Exam Content

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, CRAs, CRCs, and PIs 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:

  1. Scientific Concepts and Research Design
  2. Ethical and Participant Safety Considerations
  3. Product Development and Regulation
  4. Clinical Trial Operations (GCPs)
  5. Study and Site Management
  6. 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




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:

  1. Guideline for Good Clinical Practice E6(R1)
  2. Definitions and Standards for Expedited Reporting E2A
  3. General Considerations for Clinical Trials E8
  4. Statistical Principles for Clinical Trials E9, and
  5. 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 PI Certification Handbook.

Exam Format

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 CCRA, CCRC, and CPI 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

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.

Eligibility for Your Exam

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.

PI Certification Eligibility Requirements

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:

  • Have a doctorate level degree and;
  • Have proof of employment as a PI during at least two (2) of the most recent five (5) years and;
  • Perform all of the essential duties as detailed below.

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.

PI Essential Duties

As defined by the Academy, 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:

  • Responsible for the safe and ethical conduct of a clinical trial;
  • Evaluates the study proposal and decides on participation;
  • Facilitates or verifies formal approvals according to regulatory requirements and International Conference on Harmonisation (ICH) Good Clinical Practice (GCP);
  • Ensures that all site initiation activities are performed to start and conduct the study;
  • Participates in the selection of trial subjects according to the recruitment strategy;
  • Performs or supervises the conduct of study-related procedures and monitors the safety of the trial subjects and investigational staff;
  • Collects accurate and verifiable data and other essential study documents;
  • Ensures compliance with regulatory requirements and ICH GCP, the protocol and the handling of the investigational product;
  • Communicates with subjects, sponsor’s personnel, and Institutional Review Board
  • Ensures adequate close-out of the study

CPI® Eligibility Requirements

The eligibility requirement options below should be met before applying for the CPI® program.

Education Requirements and Documentation to be Submitted

  • Doctorate level degree (DDS, MD, or equivalent degree such as DO, MBBS or MBChB, PhD, PharmD, DNP, or
  • A licensed Physician’s Assistant or Nurse Practitioner who has served in a PI role, as documented below; current license required and must be submitted with application
  • CV must reflect name of educational institution, location (city, country), title of degree and date awarded.

Experience Requirements and Documentation to be Submitted

For at least two (2) of the most recent five (5) years*:

  • 1572 / PHS 398 / QIU (or equivalent) OR
  • IRB/IEC approval letter to conduct the study OR
  • Protocol approval letter for the study OR
  • Signed copy of an investigator agreement/protocol signature page OR
  • Other regulatory authority document verifying your role as a Principal Investigator or sub-investigator on the clinical trial being submitted in support of eligibility

Any proprietary details may be blocked out.

*Substitution for Work Experience Requirements

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.

Clinical Research Certifications (Option 1)

The Academy 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.

Clinical Research Education Programs (Option 2)

The Academy permits applicants who have completed a clinical research education 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 Education Programs- Substitution for Work Experience Requirements section).

Eligibility Review Process

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.

  1. Apply
    • Receive e-mail confirmation
    • Application enters eligibility review process within seven days
    • Check your e-mail for any reviewer requests
  2. Eligibility Review
    • “Ineligible” outcome: applicant receives up to three levels of automatic review (each can take seven days)
    • Applicant may be asked for more documentation
  3. Eligibility Determined
    • “Eligible” candidates receive Eligibility Notice with ID number and must schedule exam appointment
    • “Ineligible” applicants are refunded

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.

Confirmation of Eligibility and Testing Information

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 Manager. 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.

Applying for Your Exam

When to Apply

After determining that you meet the eligibility requirements, you must submit together the application, supporting documents, and full payment for a complete application.

Exam Dates, Deadlines, & Fees

The total cost to apply includes an Exam fee and Application fee as follows:

Spring 2017 Exam Test Dates: February 23 – March 20, 2017

Early-Bird Application Dates: October 19 – December 1, 2016

ACRP Member Rate
Application Fee: $135
Exam Fee: $300
Total: $435

Non-Member Rate*
Application Fee: $135
Exam Fee: $350
Total: $485

Regular Application Dates: December 2, 2016 – February 3, 2017

ACRP Member Rate
Application Fee: $135
Exam Fee: $325
Total: $460

Non-Member Rate*
Application Fee: $200
Exam Fee: $400
Total: $600

*All Non-Members who apply will receive one free year of ACRP Membership upon successful passing of the exam.

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 to verify your ACRP Membership status and confirm the total payment due at time of application.

Transferring to Next Exam Window

ACRP offers a one-time transfer from the current exam offering to the next. There are two situations in which candidates may take advantage of this:

  1. If a candidate is determined ineligible for the current exam window, but will have met the eligibility requirements by the next exam window; or
  2. If an eligible candidate withdraws from taking the original exam for any reason (up to five [5] days before a scheduled exam appointment).

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 Exam Application Form before the end of the exam window for which you had originally applied.

If you have an exam appointment scheduled, you must first cancel it directly with Prometric before submitting the Request to Transfer Exam Application Form to ACRP.

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 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 the Academy. 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, the Academy will mail a refund check to the original payer.

Contact for any other refund inquiries.

Submitting Your Application and Supporting Documents

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:

  1. CV/resume (signed and dated with date of application submission)
  2. Job description
  3. Proof of Employment (CPI only)
  4. Educational program certificate (if required)

Upload documents as part of the online application.


Printable Application

Payment Options: Credit Card, 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:

  1. CV/resume (signed and dated with date of application submission)
  2. Job description
  3. Proof of Employment (CPI only)
  4. Educational program certificate (if required)

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 the Academy and is being prepared for the Eligibility Review process. Please allow up to 10 days to receive your eligibility email notification.

Rescheduling/Canceling Appointment

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.

To reschedule or cancel an exam appointment, you must contact Prometric at or by phone with your appointment confirmation number.

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:

  • Application Cancellation Request (for cancellation and requesting a refund only); submit up to 5 days before scheduled appointment. Refer to the Refunds section.

Your request must be received by the Academy at within the time specified or all fees paid will be forfeited.

Scheduling Your Exam

How to Make Your Exam Appointment

Once you have been determined eligible you must schedule an appointment to take the exam within the exam date range. View testing locations at or by phone.

1. Obtain Eligibility ID Number

2. Make Your Appointment

  • Select location, date, and time

3. Keep Your Appointment Confirmation

  • Review and print your confirmation. Use it if you need to cancel or reschedule your appointment

Exams are scheduled through Prometric, the Academy’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 Canceling Your Appointment

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 the Academy at 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:

  • Emergency room visit or hospitalization
  • Severe medical condition requiring hospitalization
  • Death of an immediate family member (e.g., spouse, child/dependent, parent, grandparent, sibling)
  • Call to active military duty
  • Jury duty

View full Policy on Transfers, Cancellation, No Shows, Refunds and Re-Examination.

Taking Your Exam

Testing Requirements

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:

  • Appointment Confirmation: Bring a copy. It contains the address and phone number of the testing center.
  • Proper Identification: To access a secure testing center you, must present proper identification. Also, name changes (due to marriage, for example) are common, but can prevent a candidate access to the exam if not properly presented. Improper Identification is the most common reason our candidates are denied to the exam.
  • Expected Arrival Time: If the candidate is late by 15 minutes or more, the test center will deny a candidate access.
  • Security Screening: The test center is serious about security.
  • Items Permitted/Not Permitted
  • Resources Available at the Test Center: A few resources are provided at the test site.
  • Getting Help during the Exam: Know what you can do to get help when an issue arises.


Contact if you cannot find an answer in the PI Certification Handbook (Section: Taking the Exam).

For more Test Center FAQs, view Prometric’s Test Regulations.

Preparing for Your Exam

Steps to Prepare for the Exam

The best preparation for ACRP Certification exams is understanding the knowledge requirements of your role and their application to clinical research.

The Academy 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 the Academy provides, and come to the exam well-rested and prepared.

Study Tips

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: The Academy 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.

Test Taking Strategies

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:

  • Read the entire question before you look at the possible answers.
  • Come up with the correct answer in your head before looking at the possible answers; this way, the choices given on the test won’t distract you from focusing on the question.
  • Read all the choices before choosing your answer so that you select the best one.
  • Eliminate answers you know are not correct.
  • There is no guessing penalty, so it’s always best to take an educated guess and select an answer if you are uncertain of the answer.
  • Don’t keep on changing your answer; usually your first choice is the right one, unless you misread the question.
  • Go through the exam and answer the questions you know first. Mark the others for review and then go back to those you skipped over. This will ensure that you don’t lose time by focusing on one question you aren’t sure about.

Optional Exam Prep Resources

ACRP and The Academy offer a variety of resources to help you study and prepare for your ACRP Certification exam, including practice exercises, eLearning programs, apps, and more.

Learn More

Why ACRP Certification?

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.


Certification Resources

Browse our index of important resources, including Certification forms, web pages, references, policies, and other helpful materials for earning your ACRP Certification.