Lifting the Veil on Clinical Research Certification

June 01, 2016

Navigating the Confusing World of Accreditation and Certification

Clinical research certification, certified clinical researcher, certified project manager, qualified clinical researcher, certificates, accreditations, qualifications, etc, etc, etc.

With so many options available how can you decide which is right for you or your team?

Smoke & Mirrors – Let the Buyer Beware!

Clinical research organizations are increasingly becoming focused on professional certification as a tool to evaluate staff competence – an essential component of bringing new treatments to market effectively and efficiently. A meaningful professional certification process is a valuable tool for identifying competence gaps, retaining staff and reducing redundant “sheep dip” training. However, with so many organizations offering certification programs for clinical research professionals decision makers often find themselves overwhelmed and confused.

Watch Out for Poor Practices and Grand Claims

The methods by which programs are quality assured and internationally recognized vary enormously.  At the lower quality end of the market, organizations self-certify or self-accredit their own programs and there are no independent assessment or verification processes. Unfortunately, within our industry this practice is widespread and some very well-known organizations are offering certification or accreditation programs that are not part of any recognized quality assurance process – and cost is certainly not any indication of quality.

Other organizations may have good processes in place as part of a wider quality assurance system, but make claims that cannot be substantiated e.g. “guaranteeing” competence because someone has passed a test.

Important Questions to Ask

The good news is that by asking a few questions it often is easier to separate organizations that have a robust and meaningful quality assurance process in place from those that don’t.  You may find the following list of questions useful:

  • Is it the program or the individual that is accredited / certified or both?
  • What is the process for accrediting / certifying the program / individual?
  • What international framework is the certification / accreditation mapped to?
  • Are internationally recognized learning credits awarded? If yes, how do they convert to CPD / CME / CEP / CPE / contact hours?
  • What is the quality assurance process?
  • What external agencies / oversight is involved?
  • How is consistency ensured from region to region and from one year to the next?
  • What percentage of people pass the certification / accreditation? (Beware of organizations claiming a 100% pass rate!)
  • What is the pass / fail criteria? g. is it based on proof of competence or passing a certain percentage of questions in a multiple choice test?
  • How is the program aligned to the specific job role/tasks?
  • What are the assessment / validation / verification processes?
  • How are assessors / validators / verifiers quality assured and monitored?
  • Is it necessary for the participant to attend one of the organization’s training programs or is certification a stand-alone process?

The Accreditation Landscape – Who Are The Main Players?

Across the world there are a number of different accreditation/quality assurance standards related to training and/or certification programs. These standards vary and generally cannot be compared on a like-for-like basis because they are focused on accrediting completely different things.  The table below provides a synopsis of some of the most widely recognized standards and the criteria they are focused on.

Membership Organization, University or Accrediting Organization?

There are a wide range of organizations offering certification / accreditation programs. The table below gives an overview of the professional certifications available for each role by some of the best known organizations in our industry.

University Programs

University programs have been excluded from the table below because they vary enormously in what they offer. In general they tend to be theoretical (for example focusing on protocol design) rather than pragmatic and aligned to the real-work that many clinical research professionals do as part of their day to day role.  They also require significant time commitment to write assignments, etc. so can be difficult to balance with a full time job.

Options for Professional Certification

Quality Assurance & International Recognition

The table below compares how certification programs offered by some of the best known organizations in our industry are quality assured and internationally recognized.

Competency types evaluated have also been compared.  You will note that many certification programs are focused on testing job-specific knowledge. This is a good starting point, however does not give an indication of the person’s ability to perform in real work situations.

Is Training Necessary – What About Experience?

In this blog we have purely focused on certification. Quality and content of training programs has not been considered.

If you are an experienced clinical research professional, please contact the relevant organization directly to ask whether you would need to attend a training course to gain certification or whether certification is a stand-alone process.

Experience Does Not Necessarily Equate to Competence

Historically, the clinical research industry has been focused on the amount of experience someone has gained and used this to determine whether they are an appropriate person to work on a clinical trial. However, most people can provide examples of “experienced” people that are not good at their job due to lack of skills, knowledge or professional behaviors.

IAOCR’s ethos has always been that proof of competence i.e. proof that a person possesses the skills, knowledge and behaviors to perform their role effectively, is a far better measure of appropriateness.  Additionally, projects with competent staff operate more effectively and efficiently with less risk. We are therefore happy to assess competence regardless of length of service and regardless of how the person has been trained  – IAOCR certification is purely focused on whether the person can provide evidence to prove that they are competent!

Next Steps

Find out more about Accreditations for Individuals.

Find out more about Accreditations for Organisations.

Contact Us to organize a call or request further information.


Please note that the information provided in this blog has been gathered from the websites of the organizations featured during June 2016. Whilst we have endeavored to ensure that it is correct, IAOCR cannot guarantee its validity.

If you are seeking a certification program for yourself or your organization we strongly recommend that you carry out your own investigations. The information provided in this blog should not be relied upon to formulate a decision.

We welcome feedback and input from the organizations concerned and will update this post if required to ensure that it is up-to-date and accurate. Please email contact us to provide feedback.

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