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European Pharmaceutical Contractor
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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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