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These two types of databases generally have important differences in their sources, their quality levels, their uses, and their customers. Reconciliation of SAE data and the clinical trial database that houses the relevant SAE reports is not always straightforward. Different sponsors have vastly different methods of managing these two databases.
Safety Data Management and Reporting - Page 17 of 22 - Good clinical data management practices include provisions for reconciling important disparities between serious adverse events that are captured both in the SAE database and in the clinical trial database. The business-balance perspective encourages users of these databases to recognize that clinical trial databases may be queried or updated while SAE databases are not and that, consequently, some discrepancies may exist because preliminary medical judgments were later changed in light of updated information.
General Safety Data
The FDA draft document Reviewer Guidance: Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review (November 1996) provides specific guidance to industry that reflects thinking within the FDA about safety data.
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