By Kamila Novak, KAN Consulting
“Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).”1
So reads Good Clinical Practice (GCP) principle 2.8. Note the lack of required competency. In addition, the GCP Guideline briefly addresses qualifications of IRB members, monitors, and auditors. Yet, the word “competence” appears just once in the GCP in relation to medical/laboratory/technical procedures/tests, stating that “the competence of facility to perform required test(s), and to support reliability of results should be documented” (GCP 8.2.12). This sounds strange to me since a facility, a non-living object, cannot be competent or incompetent — only people can be. A facility can be adequate or inadequate and requirements for adequacy appear on almost every page of the GCP Guideline.
It is very different in the Good Laboratory Practice (GLP)2 and Good Clinical Laboratory Practice (GCLP)3 world. In these guidelines and relevant standards, e.g., ISO 15189 Medical Laboratories4, the requirements for personnel competencies appear often and are called to be evaluated periodically. An interesting and confounding difference.
The sparse use of “competence” in the GCP Guideline can silently contribute to the conclusion that all we need in the GCP world are qualifications, be it for investigators and their teams, IRB members, monitors, or auditors. It is as if being qualified automatically means that a person is competent. Is it so, or is it not?
Competent And Qualified Are Not One In The Same
A few weeks ago, my colleagues and I at the Society of Quality Assurance (SQA) talked about competence and qualifications and whether they are the same thing. Our conclusion was negative; meeting qualifications are not equivalent to having competence. Competence is the ability to apply one’s qualifications, do a good job, learn more, apply new knowledge, grasp principles, and keep improving.
I have seen striking examples of people with high qualifications who were not competent, such as a woman hired as a senior clinical research associate (CRA) many years ago. Her resume and certificates impressed the interviewer, who hired her without hesitation. Unfortunately, everything she did had to be corrected and re-done; she was not able to use what she had learned and do the job. She had an amazing memory, but that was all. Earlier this year, I interviewed a clinical team during a remote vendor qualification audit. I asked them to describe something they were supposed to do routinely in every study. The answer was — silence. I rephrased the question, thinking a language barrier was to blame. The result was the same. However, I got a perfect answer the following day when one of the interviewees read the relevant SOP — with their camera off. Of course, all personnel of the audited company had adequate qualifications, perfect curricula vitae, and 100% training compliance.
It puzzles me why competence is such an elusive concept in the GCP world. Competence and the ability to become competent is not much considered and rarely tested in hiring. Yet, it is more important for performing the job than relevant education and years of (paper) experience. It is the desire, the ability, and the willingness to learn that determine if somebody is going to perform well. Instead, sponsors and CROs often insist on unwise requirements for experience, such as six (or more) years of monitoring experience in oncology trials.
Why do I say unwise? I have three main reasons. One: Everybody in the field had no experience once upon a time. Somebody gave us a chance; we learned and grew as professionals. If I do not give a chance to a motivated person who has up-front invested in her training, I have wasted her talent and undermined her motivation. Two: Would somebody who does a great job stay in the same position, e.g., a CRA, for six or more years without promotion? If the person has not been promoted, does she really do a great job, and am I eager to put my study in her hands? Three: As an auditor, I find much more deficiencies in the work of people who perform the same job for a long time than in the work of newbies. Why? The veterans are self-confident, sure they can do it with their eyes closed, and have switched to autopilot. It is understandable. A junior person does not have such self-confidence and pays close attention to their tasks. I prefer such a person to take care of my study sites.
Similar to hiring, clinical personnel evaluations rarely address competence. Yes, we have all kinds of KPIs, and fitting ones can indirectly point to competence. We may even have key quality indicators (KQIs), although they are much less used. What we lack, though, are fit-for-use, practical competency frameworks for different roles in the GCP world.
The lack of a clinical trial-related competence concept led several organizations and institutions to attempt this challenging task.
Disparate Sources Define And Evaluate Competency
The Association of Clinical Research Professionals (ACRP) produced competence domains and a competence framework5 for monitors, coordinators, and investigators. Reading the GCP domain description, I am surprised that, out of 12 points, eight start with “describe”. Being able to describe something says more about my ability to memorize it than my understanding and my ability to do it. Then under the heading “Clinical Trial Operations” (GCPs), we read that it “encompasses study management and GCP compliance, safety management (adverse event identification and reporting, postmarket surveillance, pharmacovigilance), and handling of investigational product.” Well, postmarket surveillance and pharmacovigilance follow Good Pharmacovigilance Practice (GVP), not GCP.
The Core Competency Framework for Clinical Study MonitoringTM mentions “ISO regulations and requirements” (without mentioning which ISO). This is misleading since ISO standards, work products of the International Organization for Standardization residing in Switzerland, are not regulations and their requirements are mandatory to be followed only by those organization that voluntarily decided to get certified for a given standard or standards. There is no ISO standard applicable by default to clinical studies. I do not want to diminish the efforts and work to produce the competence domains and frameworks; however, more work is to be done and space for improvement exists.
The Joint Task Force (JTF) for Clinical Trial Competency partnered with the Multi-Regional Clinical Trials (MRCT) Center of Birmingham and Women’s Hospital and Harvard and published the Core Competency Framework for the Clinical Research Professional Version 3.1 in February 2020.6 It includes eight domains and lists competencies for fundamental, skilled, and advanced levels. It uses action verbs, such as develop, explain, plan, identify, align, and evaluate, and provides examples. It can serve as a reference for companies to define their requirements and include them in standard operating procedures, job descriptions, training programs, and employee evaluation.
Finally, the Medical Writing Community of the Drug Information Organization (DIA) produced a competency framework for medical writers, currently available as a second edition approved and released in February 2017, and published in the DIA Journal Therapeutic Innovation and Regulatory Science.7,8 Apart from technical skills, it includes behaviors and ethics. This is an example to be followed.
Several academic institutions and other organizations published their approaches and work products as well.
Awareness Lags Despite Good-Faith Efforts
Regrettably, there is no general awareness and little implementation efforts in the GCP world. When I audit, I always review job descriptions, CVs, and training records of key personnel, as well as training plans and programs. My audit interviewees never mention competence when they describe employee or contractor selection, hiring, and onboarding, or equal competence with years of experience or an academic degree. I used to produce a “Go-Alone Certificate” to people reporting to me when I was confident that they could handle their job alone, without close supervision, i.e., they were competent. These certificates are now part of history, for once something we should have rather kept. When I ask auditees how they document that a newly hired person is competent enough to handle their tasks on their own, the response is either that they do not document it or they say something like, “He/she completed the onboarding training.” The training is almost 100% self-reading of SOPs and, in some companies, watching a few videos. Is it enough to be sure the new staff can work independently?
How Did We End Up Like This?
One reason is that it is not usually easy to succinctly define what the person fulfilling a given role should be able to do and how, since there are so many tasks and activities. Every job description has the last point in required duties articulated as “any other task that may be assigned.” How can we differentiate the “must haves” from the “nice-to-haves”? How can we make competence requirements practical and meaningful? Like metrics and KPIs, more does not mean better despite the lingering notion that quantity ensures quality.
In many GCP processes, especially the more complex ones involving multiple parties, we develop playbooks. Practical, actionable, visual. Can we use the same approach to define key competencies? A GCP competence playbook for a role may have one or two pages of key technical skills; one page of key soft skills, such as critical thinking, communication, problem solving, presentation, coaching, etc.; one page for behavior; and one page for ethics. This playbook could help people understand requirements and expectations for different roles and see what they need to improve. It may help managers evaluate their subordinates against clear frameworks, develop fit-for-purpose training programs, standardize job descriptions that currently vary a lot from one company to another, etc.
Perhaps we can learn from our GLP colleagues. Since competence evaluations have been performed by them for a long time, they have likely developed practical approaches we can modify for and adopt in the GCP world.
About The Author:
Kamila Novak, MSc, got her degree in molecular genetics. Since 1995, she has been involved in clinical research in various positions in pharma and CROs. Since 2010, she has been working as an independent consultant focusing on QA &QC being a certified auditor for several ISO standards, risk management, medical writing, and training. She is a member of the Society of Quality Assurance (SQA), the World Medical Device Organization (WMDO), the European Medical Writers’ Association (EMWA), the Drug Information Association (DIA), the Continuing Professional Development (CPD) UK, and other professional societies.
- ICH E6 (R2) Good Clinical Practice, November 2016
- Good Laboratory Practice, OECD, https://doi.org/10.1787/2077785x
- Good Clinical Laboratory Practice, WHO, 2009, https://fctc.who.int/publications/i/item/good-clinical-laboratory-practice-(-gclp)
- ISO 15189:2022 Medical Laboratories, International Organization for Standardization, Switzerland
- ACRP competency framework
- JTF website https://mrctcenter.org/clinical trial-competency/, feedback and suggestions should be sent to email@example.com
- Clemow, David & Wagner, Bertil & Marshallsay, Christopher & Benau, Danny & L’Heureux, Darryl & Brown, David & Dasgupta, Devjani & Girten, Eileen & Hubbard, Frank & Gawrylewski, Helle & Ebina, Hiroko & Stoltenborg, Janet & York, JP & Green, Kim & Wood, Linda & Toth, Lisa & Mihm, Michael & Katz, Nancy & Vasconcelos, Nina-Maria & Aoyama, Yumiko. (2017). Medical Writing Competency Model – Section 1: Functions, Tasks, and Activities. Therapeutic Innovation & Regulatory Science. 52. 216847901772158. 10.1177/2168479017721585.
- Clemow, David & Wagner, Bertil & Marshallsay, Christopher & Benau, Danny & L’Heureux, Darryl & Brown, David & Dasgupta, Devjani & Girten, Eileen & Hubbard, Frank & Gawrylewski, Helle & Ebina, Hiroko & Stoltenborg, Janet & York, JP & Green, Kim & Wood, Linda & Toth, Lisa & Mihm, Michael & Katz, Nancy & Vasconcelos, Nina-Maria & Aoyama, Yumiko. (2017). Medical Writing Competency Model – Section 2: Knowledge, Skills, Abilities, and Behaviors. Therapeutic Innovation & Regulatory Science. 52. 216847901772368. 10.1177/2168479017723680.