Who This Guide Is For (and Why I’m Writing It)

I failed a certification exam once. Years later, I passed two ACRP exams on my first attempt by doing almost everything differently. This post is exactly what I wish I had back then.

Passing an ACRP certification exam materially changes how you are perceived as a clinical research professional.

In my case, it fundamentally changed my confidence and how I approached clinical research decisions.

I received my ACRP Certified Professional (ACRP-CP®) credential on September 27, 2018. Subsequently, I decided to take the ACRP Medical Device Professional (ACRP-MDP®) specialty exam a few years later. I received my ACRP-MDP® credential on September 4, 2025. 

This step-by-step guide is for anyone who is interested in the following ACRP certification exams and credential(s):

• ACRP Certified Professional (ACRP-CP®)
• Certified Clinical Research Associate (CCRA®)
• Certified Clinical Research Coordinator (CCRC®)
• Certified Principal Investigator (CPI®) 
• ACRP Medical Device Professional (ACRP-MDP®)
• ACRP Project Manager (ACRP-PM®) 

Step 1: Confirm Your Eligibility for the ACRP Certification Exam

Before registering, you must confirm that you meet ACRP’s eligibility requirements. There are two ways in which you can qualify for the exam:

Option 1: Work Experience

This option is applicable if you (a) do not currently hold an ACRP certification credential or (b) have not completed a clinical research education program. Clinical research professionals with 3,000 hours of verifiable work experience are eligible to sit for the ACRP certification exam (ACRP-CP®, CCRA®, CCRC®, CPI®). 

CPI® applicants are subject to education requirements i.e. 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 or Sub Investigator who has served in a PI role.

CPI® candidates must provide regulatory documentation verifying service as a PI or Sub-Investigator.

Option 2: Work Experience + Waiver 

This option is applicable if you (a) currently hold an ACRP certification credential or (b) have completed a clinical research education program. CPI® applicants who have obtained a doctorate degree, would qualify for this option. ACRP may grant one experience waiver amounting to 1,500 hours of work experience to applicants. 

CPI® applicants are subject to proof of employment as a PI or Sub-I  for at least one (1) of the most recent five (5) years for applicants. A regulatory authority document verifying your role on the clinical trial should be submitted in support of eligibility.

ACRP is strict about what it considers qualifying work experience. 

To qualify for the exam, your work experience should be related to human subject research, is a paid contractual agreement – employer/employee, and can be verified by ACRP through the employer. Any work that is part of a degree track or education program, any experience older than ten years, and internships paid or unpaid are excluded. It is important to note that ACRP-MDP® and ACRP-PM® are speciality exams. This means you can only appear on these exams if you hold at least one ACRP certification credential i.e. ACRP-CP®, CCRA®, CCRC®, and/or CPI®.

Step 2: Register and Schedule the ACRP Exam (and Why Timing Matters) 

Once you’ve determined your eligibility for the certification exam, it’s time to register to take the exam.

The registration process is fairly straightforward. You will need to set-up an account with ACRP, if you don’t already have one. Then you’d follow the instructions on the ACRP website to complete the registration process including making payment for the exam fees. 

Registering for the exam is often the most psychologically difficult step. 

This is a natural response because you want to ensure you have sufficient time to study for the exam. The exam fees can be high as $600.00 depending on when you complete the registration (early bird versus standard registration).

Here is how I planned my ACRP-CP® and ACRP-MDP® exams.

Exam	ACRP-CP®	ACRP-MDP®
Registration Date	February 18, 2018	July 20, 2025
Exam Date	September 27, 2018	September 4, 2025
Duration between Registration and Exam Dates	221 days/ 7 months & 9 days	46 days/ 1 month & 15 days

As you can see, I gave myself ample time to prepare for my ACRP-CP® – precisely 7 months and 9 days! Allowing sufficient time to prepare for the exam calmed my nerves. As I gained more experience and appeared for the  ACRP-MDP®, I only gave myself 1 month & 15 days to prepare for the exam. 

Simply put, the act of registering for the exam mentally prepares you to study and take the ACRP exam. 

First-time candidates typically benefit from several months of preparation; experienced professionals may need significantly less time. However, you are responsible for taking the initiative to register for the exam. Ultimately, the decision – and the outcome – rests with you.

I understand that these exams are expensive to take. However, you should think about what it’s going to cost you if you and your career if you don’t take the ACRP exam. For some people, it may be a promotion. For others like me, it may be simply improving knowledge and understanding of clinical trials. 

Once you’ve registered to take the exam, ACRP will notify you on how you can schedule the exam. PSI Services LLC (PSI), a testing provider,  is responsible for administering ACRP exams. You will have the option to take the test in person or remotely. Once you’ve scheduled your exam, it’s time to move onto step 3.

Step 3: Build a Study Strategy That Matches How the ACRP Exam Is Tested 

Before you start studying for the ACRP Certification Exam, you need to have a plan. Before you begin studying, answer the following questions honestly.

1. What time of the day am I best equipped to study for the exam?
2. How many hours a day or week can I allocate to study for the exam? 
3. Do I need to take time off to study for the test? If yes, when?
4. What am I afraid of? 
5. What will you need to stay consistent with your studying? 
6. How will I know if I am on track with studying for the exam? 

When I appeared for the ACRP-CP® exam, I allocated approximately two-hours every morning, Monday to Friday, to study for the exam. I did most of my studying early in the morning from 6am to 8am or when I needed a little break from work. Sometimes I spent time at my local library reading exam materials in the “Quiet Room.” 

My primary concern was failing the exam after years of experience. Back in 2008, I appeared for the Certified Clinical Research Associate (CCRA®) exam and did not pass. Now with 10-years of experience under my belt, I was determined to pass the ACRP-CP® exam. 

The advantage was that I clearly understood my knowledge gaps. 

I knew I had to improve my understanding of the following topics:

1. Clinical Trial Design
2. Site Regulatory Requirement(s), and
3. Monitoring

I also knew that in order to pass the exam, I had to stay focused. This meant I had to keep my work and personal travel to a minimum and ensure I had access to reading materials at all times. 

To keep up with my studying, I often referred to the ACRP Exam Content Outline (ECO). An ECO is a detailed document that lists the clinical research concepts you need to understand in order to prepare for the exam. Specifically, the ECO is made of the following components¹:

• Domains: Broad areas of knowledge and skills necessary for the role.  
• Knowledge Statements: Specific pieces of knowledge that a certified professional should possess within each domain.  
• Tasks: Practical tasks that a professional in the role should be able to perform, demonstrating the application of their knowledge.

ECO was by far my favorite exam resource. The ECO helped me identify areas where I need to work a little harder to understand the clinical research concepts. ACRP publishes an unique ECO for each of six (6) exams. I recommend you download and print a copy of the relevant ECO for reference.

In addition to the ECO, I downloaded and printed International Council for Harmonisation (ICH) guidelines for clinical research. The ICH guidelines are updated from time to time, so I recommend you download and refer to the relevant guidelines. 

• Guideline for Good Clinical Practice E6 (R2)
• Definitions and Standards for Expedited Reporting (E2A)
• General Considerations for Clinical Trials E8 (R1)
• Statistical Principles for Clinical Trials E9
• Statistical Principles for Clinical Trials E9 (R1)
• Clinical Trials in Pediatric Population E11 (R1) 
• The Declaration of Helsinki (DoH) 

When studying for the ACRP-MDP® exam, I also downloaded and printed the International Organization for Standardization (ISO) 14155:2020.

Step 4: Study the ICH and ISO Documents That Actually Drive Exam Questions

Once you’ve gathered all your exam reference documents, it’s time to start putting in the time to read and study the ECO, ICH Guideline(s), and ISO standard (if applicable) documents line-by-line. 

Reading ICH guidelines and ISO standards demands sustained focus and discipline. The materials can feel dry and repetitive at times.

One approach that proved consistently effective was limiting my goal to 10 pages per day.  

That’s it – no more and no less. 

This was a manageable goal because of my demanding work schedule. I did my best to not skip any reading days unless it was completely unavoidable. 

As I read the reference materials, it is useful to underline key concepts on the ICH guidelines and ISO standard. I always had a pencil and a ruler in my hand. I took notes in the margins and/or a separate notebook. I find writing key concepts in a separate notebook or the margin a great way to retain key information and insights. 

As my exam data approached, I re-read the underlined sections of the document and notes to remind me of important information that I might have forgotten. 

To prepare for the ACRP-MDP®, I also enrolled and completed the Good Clinical Practice (GCP) ICH E6(R3) course. 

ACRP exams are designed to test your knowledge and understanding of the following topics:

Domain(s)/ Exam	ACRP-CP®	CCRA®	CCRC®	CPI®	ACRP-MDP®	ACRP-PM®
Scientific Concepts and Research Design	–	12	8	15	3	6
Ethical and Participant Safety Considerations	18	18	19	22	15	6
Clinical Research Standards and Guidelines	17	–	–	–	–	–
Regulatory Requirements/ Affairs	–	14		–	–	6
Clinical Trial Operations (GCP)	25	18	23	21	18	15
Product Development and Regulation	–	–	13	12	–	–
Investigational Product/ Device Regulations	–	–	–	–	6	–
Study/ Site Management	21	25	22	17	18	18
Data Quality	–	13		–	–	–
Data Management/ Informatics	–	–	15	13	–	–
Research Design and Data Management	19	–	–	–	–	–
Business Management, Leadership, and Professionalism	–	–	–	–	–	9
Total Number of Questions*	100	100	100	100	60	60
Total Time (in minutes)	180	180	180	180	90	90

For ACRP-CP®, CCRA®, CCRC®, CPI® there will be 125 questions on the exam. 25 of these questions are pre-test items and do not affect a candidate’s score, nor are they identified to the candidate. ACRP‘s ACRP-MDP® and ACRP-PM® specialty exams consist of 60 multiple-choice questions, of which there are 10 pre-test items. 

As you can see from the above table, Ethical and Participant Safety Considerations, Clinical Trial Operations (GCP), and Study/ Site Management are the core principles that are tested across all exams. Approximately 60% or greater exam questions will cover these three clinical research domains. For this reason, I would advise that you prioritize reading and understanding the following documents first:

• Guideline for Good Clinical Practice E6 (R2). Starting Fall 2026, ACRP is moving towards incorporating Guideline for Good Clinical Practice E6 (R3) into the certification exams 
• General Considerations for Clinical Trials E8 (R1)
• The Declaration of Helsinki (DoH) 

Step 5: Learn from Professionals Who Have Already Passed the ACRP Exam

After I completed the ACRP recommended reading materials, I had doubts on my ability to pass the exam. 

To address my doubts, I reached out to a handful of individuals who had successfully passed the ACRP certification exam. I used LinkedIn to identify and contact these individuals. I sent them a simple message like the one below:

Hey, I noticed on your profile that you are ACRP-CP certified. I was wondering if you would be willing to share how you prepared for the exam including any tips/ pitfalls to watch for. I’ll be appearing for the exam next month. Would you be willing to speak with me for 15 mins? Thank you!

Several experienced colleagues were willing to share how they prepared. I spoke with some of them on the phone and others sent me detailed email responses like the ones below.
Here is what stood out:

• “Pertaining to the ACRP-CP exam I basically stuck to the DCO as my study guide. I also did multiple courses on the ACRP-CP learning portal, the ICH gap was one of the most helpful ones to identify my knowledge gap. I reviewed each of the ICHs in great detail as well prior. It also paid off because it made me recall unique regulations of each one.”

• “Be very, very familiar with ICH E2A, ICH E6, ICH E8, and the Declaration of Helsinki. The latest version of the Declaration of Helsinki is available on the World Medical Association website, all ICH’s are available on the ICH website and ready to download as pdf…”

These conversations definitely helped boost my confidence. 

ACRP also offers practice exams for the ACRP-CP®, CCRA®, CCRC®, and CPI® certifications. The practice exams can be purchased directly on the ACRP website. 

Step 6: Take the ACRP Exam — What to Expect on Test Day

The final step in this journey is to take the actual test.  PSI administers the ACRP certification exams. I decided to take both exams in-person, at a local PSI exam center. 

When I appeared for both exams, I clearly remember entering the testing center feeling prepared and mildly nervous. At the time of check-in, I was asked to complete a security protocol similar to what one goes through at the airport.  The exam center staff verified my identity and asked me to store my belongings in a secured locker. I wasn’t allowed to take my phone or smart watch inside the testing center for obvious reasons. 

A vast majority of exam questions focused on application of ICH guidelines in clinical trials and not memorization of facts. Knowing the guidelines matters, but understanding how they are applied in real clinical trials matters more.

Feeling uncertain during the exam is expected. 

In both cases, I flagged a significant number of questions on the first pass. That feeling of uncertainty did not correlate with failing. It simply reflected the way the questions are designed.

Time management and question flagging are critical. Completing an initial pass, flagging uncertain questions, and reviewing them later made a meaningful difference in my confidence and decision-making.

Deep familiarity with ICH principles and ethical foundations is non-negotiable. Even when the exam content differs by role or specialty, these concepts consistently anchor the questions.

I clearly remember feeling elated after passing the ACRP-CP® and ACRP-MDP® exams.

When you submit the exam, you’ll see a message flash on the screen that states whether or not you passed the exam. The detailed exam results and digital certification badge (if you pass) will follow in the coming days.

What the ACRP Certification Has Meant for My Career:

Completing the ACRP certification exams marked a meaningful inflection point in my career. After earning my ACRP-CP® certification in September 2018, I stepped into a new role as Director of Clinical Operations in May 2019. Preparing for the exam forced me to strengthen my understanding of core clinical research concepts, and passing it gave me the confidence to pursue greater responsibility.

In 2025, I chose to sit for the ACRP-MDP® specialty exam for a different reason: continuous learning. I wanted to formally test my understanding of medical device clinical trials, particularly ICH GCP E6 (R3) and ISO 14155:2020. Preparing for and passing the ACRP-MDP® exam accomplished exactly that.

When you receive your exam results, it’s important to interpret them thoughtfully. For example, I scored 50% in the Scientific Concepts and Research Design domain. Initially, that felt discouraging – until I translated the percentage into actual questions. That domain represented only 6 of the 60 questions, meaning I likely missed just three. Understanding how scores map to question counts can provide helpful perspective and prevent unnecessary self-criticism.

Once you earn your ACRP certification, share your digital badge on LinkedIn, add it to your resume, and include it in your email signature. Certifications create visibility – but only if people know you have them.

ACRP certifications must be maintained every two years through continuing education or re-testing, along with a maintenance fee. While it’s easy to view this as an ongoing cost, I’ve found the opposite to be true. 

Maintaining my certification has pushed me to attend conferences, stay current with evolving guidance, and continuously sharpen my foundational clinical research skills.

You may question whether maintaining a certification is “worth the money.”  A better question is what opportunities you create by committing to continuous learning and professional credibility. For me, maintaining my ACRP certification has been well worth it – and I plan to continue doing so for the foreseeable future.

References:

1. https://acrpnet.org/certification/exam-preparation
2. https://www.iso.org/standard/71690.html
3. https://acrpnet.org/frequently-asked-questions
4. https://acrpnet.org/acrp-certification-exam-prep-packages
5. https://acrpnet.org/learning/courses/good-clinical-practice-gcp-ich-e6r3
6. https://acrpnet.org/certification
7. https://acrpnet.org/certification/maintain-certification
8. https://vimeo.com/916515515?share=copy