Lifting the Veil on Clinical Research Certification

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?  Read on to find out more, or contact us to find out more.

Lifting the veil on clinical research

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? e.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 summary table below provides a synopsis of some of the most widely recognized standards and the criteria they are focused on.

  • ANSI (American National Standards Institute)

    Accredits procedures used by other organizations to develop standards.

    What are they accrediting?

    ANSI accreditation is focused on ensuring that organization’s procedures are open, balanced, follow due process and meet ANSI’s requirements for consensus.  

    Internationally recognized?

    ANSI promotes the use of US standards internationally.

  • IACET (International Association for Continuing Education and Training)

    Accredited by ANSI to produce standards for continuing education and training.

    What are they accrediting?

    IACET accreditation is focused on how training programs are developed. (It does not take into account the technical content of the training or delivery).

    Internationally recognized?

    IACET primarily operates within the USA.

  • IAOCR

    Provides accreditation and certification services to the pharmaceutical industry, specifically clinical research.

    What are they accrediting?

    IAOCR provides three types of accreditation, each is focused on a different but related area: –

  • Individual accreditation (certification) focuses on whether the person has demonstrated that they can perform their role/tasks competently;
  • Training course accreditation focuses on the quality of the training content i.e. if it is designed in a way that provides learners with a good opportunity to develop predetermined competencies;
  • Workforce Quality Accreditation is focused on the systems and processes that employers have in place to ensure their workforce is competent and engaged.

 

Internationally recognized?

Certifications are mapped to the International Standard Classification of Education Framework developed by UNESCO (United Nations Educational, Scientific and Cultural Organization), which are widely recognized internationally.

  • ICE (Institute for Credentialing Excellence)

    A US-based membership organization accredited by ANSI. Membership of ICE is not an indication that an organization has an NCCA accredited program.

    What are they accrediting?

    ICE created NCCA to act as its accrediting organization (see NCCA).

  • ISO (International Organization for Standardization)

    Developed ISO 17024 (amongst other ISO standards).

    What are they accrediting?

    The standard is focused on helping organizations to conduct well-planned and structured evaluations in order to ensure impartiality of operations and reduce any conflict of interest.

    Internationally recognized?

    ISO standards are widely recognized internationally.

  • NCCA (National Commission for Certifying Agencies)

    A US-based, non-governmental organization created by ICE.

    What are they accrediting?

    It accredits against NCCA’s “Standards for the Accreditation of Certification Programs”.  NCCA accreditation is focused on an organization’s ability to provide proper exam administration and scoring.

    Internationally recognized?

    NCCA accreditation is widely recognized within the USA.

  • Ofqual (Office for Qualifications and Examinations Regulation)

    Reports into UK Parliament.  It is the regulator for qualifications, examinations and assessments in England and vocational qualifications in Northern Ireland.

    What are they regulating?

    Ofqual regulations require that accreditations and qualifications must meet high quality standards.  Assessments and examinations are subject to independent monitoring to ensure that they meet the needs of learners, educational institutions and employers.

    Internationally recognized?

    Qualifications and accreditations are mapped to the International Standard Classification of Education Framework developed by UNESCO (United Nations Educational, Scientific and Cultural Organization).

  • UNESCO ISCED Framework (International Standard Classification of Education Framework)

    Developed by UNESCO to enable comparison of education statistics and indicators beyond national boundaries.

    Internationally recognized?

    The framework has been subject to extensive international and regional consultation and takes into account education systems worldwide.  CLICK HERE to read more.  Widely recognized by employers and educational institutions internationally.

  • Universities

    Degrees, certificates, diplomas and post-graduate qualifications from reputable universities are generally mapped to the International Standard Classification of Education Framework developed by UNESCO (United Nations Educational, Scientific and Cultural Organization).

    What are they accrediting?

    Their accreditation varies enormously from one program to another so check with the university directly.

    Internationally recognized?

    Many bespoke university programs e.g. those designed for specific employers are not accredited or mapped to a recognized framework. Check with the university if this is important to you.  It is wise to check whether non-degree / post-graduate programs have been accredited and mapped to the UNESCO framework.  Otherwise international recognition may be purely down to how well known and respected the university is internationally i.e. the training was provided by “x” university.

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.

Clinical Research Professional Certification Competitors

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.

Clinical Research Competency Summary

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

To request further information about IAOCR Qualified Professional Status or our IAOCR training programs please email us.

 

By Jacqueline Johnson North, Co-founder & Chief Executive

 

DISCLAIMER

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 contact us to provide feedback.

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