The Big Problem with Clinical Research Competence Validation

Clinical Research Competence Verification – What the Regulators Say Now

When IAOCR launched the Campaign for Clinical Research Competence in 2011 we openly challenged the perception that education, training and experience were sufficient to protect the rights, safety and well-being of trial subjects and ensure that the clinical trial data are credible.

Whilst many industry leaders and regulators agreed with us, at the time most were accepting of the status quo and the inherent issues that clinical trials teams with variable competence bring to the industry.  A Senior GCP Inspector at the time told us Whilst I accept competence is essential, the Government requires us to inspect against GCP.  Therefore as clinical research competence is not a requirement of GCP we will not be inspecting for it.”  Thankfully some enlightened industry leaders weren’t prepared to accept the status quo – and within a short period of time we began working with global organizations such as ACDM (Association for Clinical Data Professionals), ICON, INC Research and Thermo Fisher to help them assess competence and provide independent competence verification.

Fast forward five years and we are delighted to hear frequent reports of regulators requiring evidence of clinical research competence.  In a 2015 meeting with the MHRA (Medicines and Healthcare Products Regulatory Agency) when they provided feedback on the Global Clinical Research Competency Frameworks : Core Global Standards we discussed competence verification at length and it is clearly a focus.

Evidence of training, education and experience is not enough – evidence of robust competence assessment and verification is widely and increasingly being recognized as best practice.

Clinical Research Competency Framework

Throw Requirement for Experience Out The Window! What’s the Problem?

Our Campaign for Competence is growing – US membership organization ACRP are the latest ones to come on board with their Chief Exec, Jim Kremidas stating in a recent press release “We suggest throwing the two year arbitary experience requirement out the window and focus on the competencies required for the job.”

Whilst many people nod enthusiastically in agreement when we discuss the virtues of competence validation – after all it makes sense for patients, for the industry and commercially – it isn’t the easy option.  The nice thing about looking for two years experience and evidence of training course attendance is that it is simple to check.  Most people can review a CV for experience or check training records in a file – tick off the relevant boxes and job done! Competence validation, on the other hand, is more complex – it requires in-depth knowledge and expertise, not only of the job role but also knowledge of how to assess competence in a robust, meaningful and consistent way.  In an industry where many organizations are only beginning to understand competence, very few people have the knowledge and skillsets to implement appropriate systems in a globally consistent way.

Benefits of Competence Verification

When rolling out wide-scale competence assessment and verification programs, independent quality assurance is essential also for ensuring consistency, fairness and robustness.  This takes time and expertise, but once the frameworks and systems are in place, and the assessors are trained and competent, the ROI is significant.

Competence verification isn’t the easy option – so you may be wondering why organizations are doing it.  Benefits for employers and sponsors include:

  • Improving efficiency through effective working practices
  • Bringing new treatments to market quicker
  • Decreasing risk
  • Robust and effective method for signing off early talent
  • Saving time and money on redundant training
  • Improved confidence in competence (from patients, staff members, employers and sponsors)

Competence Validation and Your Organization

Look out for our future blogs in which we’ll look more closely at competence assessments, verification and validation.  We will also be sharing expert advice on how to transition your organization from focusing on “training inputs” to workforce quality and results.

If you are looking to implement new competence validation procedures or want to review your existing ones we would be delighted to talk with you.  Please contact us to arrange a call with one of our Workforce Quality Advisors.

By Jacqueline Johnson North, CEO & Co-Founder – IAOCR

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