The Personnel Education and Training

Already in the above section the importance of education and training has been mentioned, in this case with regard to respecting the prescriptions of SOPs. It will be important, however, that all other aspects of how to work in 

The study plan is the central document for the orderly, planned conduct of a study. The generation of study plans has thus to occupy a prominent part of the preparations for performing the first GLP compliant studies. As it has been described above for the compilation and writing of SOPs it is extremely important that this task should be tackled with forethought. It might be advis- 

While the formulation of the scientific rationale for the studies should pose no problems to the Study Directors - if there were problems with this topic, then the respective individual should not be allowed to act as Study Director - and while the observations, measurements and data to be collected are prescribed either by international guidelines (as in toxicology studies), or by the declared purpose of the study, the whole timing and organisation of the process will have to be looked at. A flow chart of study conduct, like the one already shown in figure 38, will certainly help very much in delineating the chronological order of activities to be performed. 

Writing study plans may not be a very big problem for Study Directors used to planning ahead. Since in a test facility under GLP, the study plan has to contain information enabling a later reconstruction of the study, some training in the correct drawing up of study plans. Quality Assurance will have, in this phase even more than later, the responsibility for a timely review of these plans for GLP compliance. 

---