Few people come to the pharmaceutical industry from academia with the requisite knowledge and skills necessary to plan, conduct, and report clinical research to regulatory authority standards. This knowledge and skill usually needs to be provided to the new staff by the way of in-house training.
One approach to education and training in the industry is what is called 'competency-based training'. A competency is a skill, knowledge or behavior required to undertake effectively the tasks and responsibilities for which an individual is responsible.
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 from traditional educational and training approaches. Traditional approaches tend to address the training needs of individuals based on their job descriptions, e.g. 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 monitor 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 have done to meet its drug development goals and objectives. The primary tasks of clinical research and good clinical 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 define the knowledge and skills needed by staff to complete the tasks and, finally, what education and training should be provided to understand the knowledge and skills.
When the tasks and activities are fully defined, a CBETS will ask who is going to do these tasks and how competent (e.g. expert, fundamental skills) 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 she will not be performing the tasks. The physician may, however, be supervising the monitors. It is appropriate for the monitor to receive advanced training in the requirements of monitoring, since this is one of his/ her major functions. In terms of protocol development, the physician and monitor each need expert competency to develop the protocol, since the sponsor may be investing hundreds or millions of dollars in the program. The monitor only needs fundamental skills in protocols, since his/her responsibility may be limited to implementing the protocol at the clinical site.
The CBETS can apply to behavioral and management training as well as technical training. Education and training programs in the pharmaceutical industry can be designed to provide the competencies necessary to prevent or remove obstacles to staff performance. These obstacles can be well defined in advance in a CBETS.
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