Good clinical practice staff training

Provision of adequate competent medical staff is essential for the safe and ethical conduct of studies in humans. Decisions about whether a volunteer fulfils the entry criteria for a healthy subject or should be withdrawn from a study, how to respond to an unexpected adverse event and when to discontinue a study can prove challenging to the most experienced physician. Similarly, research nurses need many organisational and other skills over and above those that they acquired during their basic clinical training. Scientific staff must be competent in the techniques that will provide the essential data. All must be properly briefed about what will be required of them during the course of a study, and must be fully familiar with local standard operating procedures (SOPs) in compliance with good clinical practice (GCP). 

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 imderstand the knowledge and skills. 

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