A competency-based education and training
system (CBETS) details the essential knowledge
and skills needed by sponsor’s staff to complete
the requirements of GCP. The concept of a
CBETS is different to traditional educational and
training approaches. Traditional approaches tend
to address the training needs of individuals based
on their job descriptions. For example, within a
sponsor company, a monitor will receive training
on how to monitor a clinical trial and a physician
will receive training in protocol development. In
this traditional education and training model, the
required tasks are functionally defined. The moni-
tor may not learn much about preparing protocols
and the physician may not learn much about
monitoring. However, each may be intimately
involved in both tasks.
The CBETS asks what tasks the sponsor needs
to do to meet its drug development goals. The
primary tasks of clinical research and good clin-
ical practice can be described rather precisely.
Once one knows what the major tasks are and
what activities are needed to accomplish these
tasks, one can then ask what knowledge and skills
are needed by staff for the tasks and, finally, what
education and training should be provided to com-
municate the knowledge and skills. A CBETS
only asks who is going to do these tasks. Only
when the tasks and activities are fully defined is it
necessary to ask who is going to do it and how
competent they need to be to complete the tasks.
In the example provided above, it is useful for the
physician to have a fundamental knowledge of the
monitoring process even though he or she will not
be performing the tasks. The physician may, how-
ever, be supervising the monitors. It is appropriate
for the monitor to receive advanced training in the
requirements of monitoring as this is one of their
major functions. In terms of protocol develop-
ment, the physician and monitor each need com-
petencies to perform the tasks of developing the
protocol. The CBETS is applicable to behavioral
and management training, as well as technical
training.
Education and training programs in the pharma-
ceutical industry should be designed to provide the
competencies necessary to prevent or remove
obstacles to staff performance.
3.3 Competency-based training
program for staff associated
with conducting clinical trialsThe following is a description of the typical knowl-
edge and competencies needed to plan, conduct
and report clinical research in a regulated environ-
ment. Each competency is described along with the
knowledge and skills a sponsor’s representative
would need to be successful in completing the task.General clinical competencies
Understanding the drug development processNew clinical staff should understand the overall
drug development process. Before new investiga-
tional products can begiven to the public, extensive
preclinical and toxicological studies are per-
formed. Staff who will be responsible for the clin-
ical portion of investigational product’s
development need to have an understanding of
the work that has been undertaken to progress the
compound through to the clinical phases. Many
clinical investigators are also involved in basic
research and often will expect the sponsor’s repre-
sentative to be able to discuss the total background
on the investigational product.
This includes understanding the vision, mission
and objectives of the sponsor. Most sponsors have a
company-specific clinical development strategy
and product development system. Individuals
new to the industry should understand the strategy
and function of the major departments comprising
the development process, as well as understanding
the decision-making approach of the sponsor’s
management bodies.
To gain this knowledge, new staff members
should attend appropriate orientation programs
on drug development and, if recommended, Phar-
maceutical Education and Research Institute,
Inc. (PERI), Drug Information Association (DIA)
overview courses on investigational drug develop-
ment or equivalent international courses. There
is considerable literature available that discusses
the drug development process such as the ‘Guide to26 CH3 CLINICAL RESEARCH EDUCATION AND TRAINING FOR BIOPHARMACEUTICAL STAFF