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3.
Automating Progress Control |
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Because of the need to integrate diverse disciplines in clinical trials, any tool which can improve communications is of immense value. Thus, various forms of remote data collection are being evaluated, even using the Internet. Although the impetus of this comes from the need to speed data collection, there may be a valuable by-product for the project manager. If one of the most difficult tasks is to collect reliable progress data from study centers, it is going to be much easier if the manager is physically linked with the center and can actually see the data which prove the progress claimed. This could form the first link in an almost fully automated progress control system, as shown in Fig. 10. |
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All progress control systems need to collect data on achievement of objectives (time and deliverables), and costs, which will be actual cash and work time expended. The diagram is not exhaustive and gives examples of sources of automated progress data. As many of the deliverables are documents, and if there is a document management system which tracks key stages (protocol sign-off, for instance), then, these stages might be linked directly with the project planning system, updating the plan immediately as the deliverable is proven. Similarly, cost information could come via an electronic link with the company's accounting system, which would use unique cost codes for particular clinical trial activities. As speculated above, direct data accrual could feed patient progress information straight into the |
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FIG. 10
Study management: New possibilities for automation. |
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