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Fig. 2
Information system design that allows data management and analysis
databases (DB) to be shared with local and remote users and clients
as a read only (R.O.) |
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Common variable names and definitions simplify the task of programming the data displays and analyses. Statistical planning and programming should be centralized but have input and review from the dispersed team. Specifications for the analysis should be detailed and drafted in parallel with the final stages of protocol planning or, at the latest, when the database structure is being developed. Unless there are compelling reasons not to, data should be displayed in the same manner across all the studies included in a particular regulatory filing. A core set of computer programs can be developed to cover all the common study definitions. If definitions need to vary according to the destination of a regulatory filing, then the set of core programs can be made specific to the requirements. |
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If the database is designed as an integrated database, then mixing and matching study data for a regulatory filing should be limited only by the specific requirements of the filing. The international database can be warehoused and accessed in the manner described earlier in the discussion on access to data. |
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E. Support for Regulatory Filings and Marketing Efforts |
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In general, the support offered by CROs does not end with a regulatory filing. The version of the warehoused integrated-study database used with each |
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