Mandatory Certification—It’s Time


Applied Clinical Trials

It is time for mandatory certification to be required for everyone involved in a clinical study.

It was over 20 years ago when I got my first job as a Clinical Research Associate (CRA). I was about six months in when I learned information that was vital to my position. What was that vital information? The 1572. The problem? I didn’t know what a 1572 was or even that one existed, or that I was required to check it during my monitor visits.

I probably don’t have to explain why the 1572 is vital to the CRA’s role. My point is we didn’t have much standardization for the CRA position 20+ years ago, and little has changed since then. The Association of Clinical Research Professionals (ACRP) certified clinical research associate (CCRA) is one option for standardization, but it’s still not mandatory if you want to be a CRA.  

Recently ACRP Director Jim Kremidas said-I’m paraphrasing-that we may have forgotten about the individuals who execute trials, and we don’t have standards for bringing in new study coordinators and CRAs, which has led to a workforce shortage in those jobs. I believe the lack of standardization also is a significant reason why turnover is so high in our industry.

To be a professional-a nurse, doctor, lawyer, etc.-in the U.S. and throughout most other countries you need to be licensed or certified through a formal education program and testing. You must also maintain your license or certification with continuing education during your career.

Why doesn’t our industry require this type of licensing for everyone involved in managing or designing a clinical study? We often focus on certification for the study coordinator and CRAs, but not the other team members who play a vital role in the outcome of a study. 

Certification can serve several purposes, from providing evidence of the experience and qualifications of a research team to validating competency when considering a new employee with or without experience. Evidence has indicated regulators believe certification reduces risk to research patients. There are fewer errors, lower costs, faster turnaround, and greater safety in clinical trials when certified professionals are involved. Feedback from the industry is clear: certification is invaluable. So why don’t we make it mandatory?

I recommend that we implement a mandatory certification for all key team members involved in a trial: at the site, the sponsor, the CRO, and the vendors. Mandatory certification would require support from the FDA and the study sponsors to be successful. The certification should be with one organization-preferably a non-profit like ACRP. The cost of certification should not be thousands of dollars. There are many ways to cover the resources and systems to maintain an industry-wide certification program and keep it running as a non-profit organization.

Here’s what I propose for certification:

Clinical Research Associate (already in place, but voluntary)

Regulatory Associate

Data Manager

Data Coordinator


Medical Writer

Medical Monitor

Quality Auditor

Study Manager (ACRP offers a project manager certificate for people with CCRA, but if you don’t have the CCRA you can’t get the PM certification)

Principal Investigator

Study Coordinator

Sub Investigator (MD, PA, NP)

Entry Level (for people with no biopharma industry experience)

You’ll see I added “entry level” to the lists of proposed certifications. We need to accommodate newcomers just entering the industry. A certification along with the minimum education requirements would be a good start. We can take a page from The National Council of State Boards of Nursing (NCSBN), the licensing board dedicated to developing nurse licensure and certification exams consistent with current practice:

First time RN licensing is referred to as license by examination; candidates take the board exam after they have completed their registered nursing educational requirements. All 50 states use the same licensing exam: the NCLEX-RN. They all have the same standard for passing, as the exam is computer adapted and graded pass-fail. (Visit for more information.)

My recommendation: Ask the many great professionals in our industry to volunteer their time once per year to teach a course, and if instructors teach a course that yields 50% of their students passing the exam they will receive continuing education credit to maintain their own certification. I have volunteered to train eager first-timers and will continue to do so because I believe in the value of new talent entering our industry.

We’d see more eligible candidates if we were willing to train and support them so they could obtain certification. I’ve often hired and trained people fresh out of school or transitioning from a different industry. They’ve all become solid professionals because of that training-and my company’s requirement that they achieve and maintain the CCRA certification. I’m also a fan of internships at sponsors, CROs, and sites. Many of the large CROs have a training program for new graduates to become CRAs. This is a great start, but it needs more support from the study sponsors. 

Every company involved in a clinical trial should be testing their employees’ competence in clinical research on a yearly basis. A simple exam for each key area of research (data, regulatory, monitoring, statistics) can be implemented easily with the employee’s yearly review process. Only need 5 to 10 well written questions would be needed.

Creating a standard process for how we evaluate people can fix the turnover problem and weed out people who don’t belong in our industry. It should be similar to going to school. If you don’t pass the test, then you don’t advance. Some people might say that’s not fair to those who aren’t good at taking tests, but would you want those people managing the clinical study you are participating in-which is, at its core, a test?

Regular testing and certification is the only way we can be sure the people executing trials have the required level of knowledge and experience. Implementing mandatory certification could conceivably fix the industry’s turnover problem beyond just CRAs and coordinators. Once the training standards are established, all relevant people in our industry should get certified within five years.

Finally, I’m happy to report that I know more about the 1572 than I need to at this point, but that’s a topic for a completely different article.


Darlene Panzitta is the founder and President of DSP Clinical Research. She can be reached at

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