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FIG. 7
Protocol definition: Alternative process. Courtesy of A. E. Berridge,
Technical Management Development Ltd. (adapted). |
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as long as he is empowered by top management to carry out the negotiations required. Projects too often fail when this empowerment has not been carried out (such as the project coordinator). |
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Precisely the same process can be used at any level in clinical research, whether one is planning a single study or a whole clinical development program. In practice within pharmaceutical companies, the latter more often resembles Fig. 2, probably because, at this stage, much less is clear about the whole drug project. For single studies, the trap to avoid is using tried and tested methods on a production line basis. This can stifle creativity. |
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C.
New Approaches to Written Procedures |
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Standard operating procedures (SOPs) have come a very long way since GCP entered common parlance over ten years ago. We are now seeing graphical representations of familiar processes, which aid understanding and compliance. We have already seen how SOPs provide essential tools at the project design stage, as they include standard checklists against which objectives and methods can be measured. Although clinical trials would stagnate without trying innovative methods, some standardization is a valuable time saverif this were not so, our operating procedures would not be |
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