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Are You Qualified?

Everyone involved in clinical research must be fully qualified to carry out their specific roles. This is essential so that clinical trials are conducted not only according to protocol, but also to appropriate guidelines and regulations – with the ultimate goal of protecting patients and producing valid data. Having competent staff also benefits organisations from a business perspective in being able to work efficiently and effectively. It further gives individuals the satisfaction and confidence to do their jobs properly.

In order for competence to be achieved, employees have to be properly trained. This undeniably costs both money and time, and takes people away from their frontline jobs. It is, therefore, very important that money spent on training produces the right results, and that the aim is to help employees become qualified so that they can perform their roles to the required standards.

Competence Defined


The principles and practices of Good Clinical Practice (GCP) that are described in regulations and guidelines exist to protect human subjects and validate data. The process of informed consent, using a protocol that is scientifically and ethically sound, and having adequate safety reporting systems are all well-described. However, a chain is only as strong as its weakest link. One area that is singularly lacking in detail in the regulations and guidelines concerns the competence of the various staff whose job it is to uphold the purpose and principles of GCP – namely, you and me.

Regulations deal broadly with the issue by requiring that “Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task” (ICH GCP Guideline, Principle 2.8). Education, training and experience are indeed important, but this is not the whole picture. Substandard training and narrow, poor quality experience can have a negative effect on the ability of an individual to perform. The key aspect of whether someone can fulfil their role in clinical research or not is directly related to their competence – in other words, the possession of the required and observable skills, knowledge and behaviours.

A search through clinical research guidelines and regulations for the word ‘competence’ produces a meagre return. FDA 21 Code of Federal Regulations mentions it in the context of institutional review board membership (56.107) and in the use of foreign data, relating to the competence of investigators (314.106). The ICH GCP Guideline E6 (R1) refers to competence only once in connection with the documentation of a medical laboratory to perform the required tests.

Experience Does Not Equal Competence

The changing face of the clinical research environment is putting increasing demands on the condition that staff are competent. Clinical studies are undoubtedly becoming more complex and challenging, as sponsors seek to achieve multiple objectives from the same trial to overcome some of the issues of cost and delay. The growing usage of electronic data capture systems and electronic medical records is changing the emphasis of some of the roles in clinical research, including those of monitoring and data management. A skillset that was valid 10 years ago is not necessarily fit for purpose today.

Set against this background, there is a shortage of new, trained talent coming into the clinical research sector. This seems to be an international problem; certainly it occurs on both sides of the Atlantic. A scan of job vacancies for clinical study positions advertised either online or in industry magazines will reveal that most require previous experience. Many new graduates in biological sciences complain they cannot find work in clinical research because they lack work experience – as a result, breaking into this sector of the job market proves a frustrating situation for them.

From the industry’s perspective, the situation is equally unsatisfactory, as organisations are constantly playing catchup in trying to acquire enough experienced and skilled employees to meet their resource demands. Because of the timepressured environment of clinical research and the shortage of experienced staff, the irony is that there seems to be a reluctance for companies to invest time and money into training new graduates, as the need is for staff who can ‘hit the ground running’ with little or no extra training.

Why is competence so important, and how can it impact patient safety, rights and wellbeing? The following two real life examples illustrate this:

Example 1
A clinical research associate who was monitoring a study was so preoccupied with source data verification that she omitted to check the inventory and use of the study medication for 10 months. The result was that a patient not on the study was given the experimental medication, and this error was undetected for a considerable time. Thankfully, the individual patient came to no discernible physical harm, but it is unclear what the mental impact was when the patient was informed of the error. The associate had not appreciated the need to review the dispensation and administration of the trial medications regularly. It was only by good fortune that the mistake was not serially repeated, jeopardising patients’ wellbeing on a larger scale.

Example 2
Another example of a lack of competence was when a colleague was almost enrolled into a clinical study without her knowledge. The situation occurred when she attended an extra clinic visit that she thought had been arranged as part of her normal treatment. It was only when she was presented with a consent form to sign, without any prior discussion or opportunity to ask questions, that she realised she was being invited to take part in a clinical trial. On questioning the investigator and his team, she discovered that they seemed to be unaware that they had done anything wrong, justifying their actions by saying that the study had been approved by an ethics committee.

What is the Difference?


The conventional picture of training involves attending a course, either face-toface or online, or completing an e-learning course using a self-directed approach. Depending on how the training is designed and conducted, these methods can result in a passive or irrelevant experience for the so-called learner. A certificate of attendance may be obtained, or completion of a multiple choice questionnaire may be required in order to receive a certificate. However, this certificate of attendance only verifies that the person was physically present in the room at the time the course was being conducted. Without learning through active participation, there is no guarantee that any new skills have actually been acquired.

The important factor in any training activity is to establish very clear goals of what should be learned, either in knowledge, skills or behaviours – in other words, competence-based learning outcomes should be used. This will enable individuals to demonstrate their new areas of competence after taking part in a learning activity. The learning intervention should be relevant for the person, their level of competence and their job role which, in turn, should ultimately be linked to their organisation’s goals. There should also be a mechanism for ensuring effective transfer of learning applied back in the workplace.

How Does it Work?

There are three key steps to making sure that competence-based training works for every learner:

Step One
The first step is to decide which new competencies – skills, knowledge or behaviours – the learning activity is designed to deliver, which are called learning outcomes. These competencies must be observable so that the learner can adequately demonstrate them either through a description (a demonstration of knowledge) or an application in the workplace (a demonstration of a skill or behaviour).

Step Two
The learning outcomes must be articulated in such a way that they clearly describe what the trainee may know, understand or be able to do as a result of taking part in the learning activity. These outcomes should be capable of being assessed and measured using criteria which form evidence that the learning outcome has been achieved. This evidence can include how the learner participates in a group discussion, the production of a report, and/or review of a case study, as well as evidence collected from real life experience back on the job.

For a robust ‘gold standard’ approach, there should be an independent review of the learning outcomes, their respective assessment criteria and the mechanism for collecting learning evidence to demonstrate that the assessment criteria have been achieved. The review should include checking the clarity and relevance of the outcomes, the suitability of the assessment criteria and the methods of collecting learning evidence.

Step Three

Once the training activity has taken place and the learning evidence collected, there should be an assessment that the learners have achieved the relevant outcomes. This review is to establish that they can demonstrate the required level of competence. The assessor should review the learning evidence collected, give feedback to the trainee and determine whether or not the learning evidence suitably demonstrates the achievement of the learning outcome. If the assessor is satisfied that the evidence is sufficient for demonstrating competence, the learner can be awarded a certificate of competence. If the learner has not met the requirements of the assessment criteria, further support should then be given.

Long-Term Investment


Learning and development can be a significant investment for any organisation. Consequently, it is critical that time and money are spent wisely, employing cost-effective learning methods that are directed at making individuals competent in their roles. Staff training must be conducted efficiently and effectively using competence-based methodology to ensure that a business thrives, survives and meets clinical research regulatory and legal requirements – thus safeguarding the rights and wellbeing of patients.


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Martin Robinson, PhD, is co-founder, Executive Vice President and Head of Global Regulatory and Industry Relationships of the IAOCR, where he works with a team of leading experts in clinical research competence verification using accreditations and qualified status certifications, which have been built specifically for the clinical research industry. He has nearly 30 years’ experience in the clinical research sector, including learning, development and project management.
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