Responsibilities in Good Laboratory Practice

In a way, it is certainly common sense that, on each organisational level of a test facility, responsibilities are well defined, and this common sense practice ought to start with the head of a test facility. Under normal 

The qualification and experience of a technician or scientist is subject to change Once useful skills may not be needed anymore, when the work or the equipment change, and new skills have to be developed and new experience has to be acquired. These changes have to be documented, and management has the obligation to ensure the maintenance of such records by appointing 

However, the responsibility of management does not end with the appointment of the Study Director it has also to make allowance for the possibility that, once appointed, a Study Director could become temporarily or permanently unavailable for the continuous or continuing supervision of the study. In such cases, the replacement of the Study Director, whether temporary or permanent, will have to be considered by the test facility management, taking into account the prospective duration of absence. If the absence of a Study Director could be foreseen to last for a longer period of time (up to a permanent absence), the need for a permanent replacement would certainly 

When a Study Director is temporarily absent because of holidays, a scientific meeting, illness or an accident, his or her replacement will depend on the foreseen duration of absence. An absence of short duration might not necessitate the formal replacement of the Study Director, if it is possible to communicate with him or her if problems or emergencies arise. It would certainly be a good idea in such a case to at least also nominate a deputy, i.e. to delegate temporarily some or all responsibilities to competent staff. If the study is planned so that critical study phases would fall into the period of absence, these activities may then either be moved, if feasible, to a more suitable time (with study plan amendment, if necessary), or a temporary replacement of the Study Director should then be considered. Should the absence of the Study Director be of longer duration, the solution with a replacement should be preferred rather than just to delegate the tasks to competent staff. 

The second circumstance, where a replacement must not only be considered, but is an absolute requirement, needs no discussion In the event of termination of employment of a Study Director, the need for replacing this key person is obvious. 

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