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FIG. 8
Extract from clinical project template. |
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standard. The same applies to clinical project plans, so if we have standardized our practices we will be using common project structures for similar studies. Figure 8 shows part of a typical task list, which could apply with modification to a wide range of clinical trials and which can be included in an SOP as a template. Resources and duration for each task can be estimated for each new project, which can rapidly generate budgets and overall timescales. If the SOP is followed, this means that alternative studies, or those competing for resources, are directly comparable. |
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As well as the highly structured world of GCP, which is benefiting from project management, we are now seeing the influence of a third management philosophy. Quality systems are not at all new. The modern, internationally recognized standard ISO 9000 has its roots in military equipment supply in the 1950s, and has progressed via BS 5750 in the United Kingdom [3]. In addition, the term total quality management is widely used (although not universally defined). Whatever quality system is being used, it is far more effective if it is integrated with existing management structures, rather than imposed as another layer. In the author's company, a contract research organization, two main actions have been taken to achieve this. First, all procedures have been restructured to comply with ISO 9000 and |
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