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Reproduced from Clark et al. (2001), Epidemiologic Reviews, 23(2), 191 -210, Table 1, with permission from Oxford University Press.

Reproduced from Clark et al. (2001), Epidemiologic Reviews, 23(2), 191 -210, Table 1, with permission from Oxford University Press.

safety labelling changes or other responses. These considerations suggest that spontaneous AE surveillance programs must be able efficiently to narrow a large number of reported product-AE pairs to a short list of high priority candidates, from which resource intensive case series are then compiled (Institute of Medicine, 1999).

Signalling Steps

In the sorting step (a report-based step), reports are assigned to subsets using data management tools (see Figure 19.1). The aim of sorting is to break down an undifferentiated collection of reports into meaningful subsets of manageable size. In the identification step (a report-based step) an explicit or implicit statistical model is used to select product-AE pairs for further scrutiny. Identification is therefore a form of screening in which a database of product-AE reports, each containing at least one product-AE pair, is screened for relationships that are "interesting". In the case series formation step (a case-based step), a report series of a single product-AE pair is compiled and is evaluated according to a case definition. Case series formation involves: (1) creation of a reasonably homogenous product-AE report series; (2) exclusion of reports that do not meet minimum criteria; (3) creation of a multiple case series that has medico-epidemiologic meaning; and (4) summarization of the resulting evidence in favor of a product-AE relationship. In the case series characterization step (a case-based step) the case series is further examined for patterns and disproportions. The purpose of case series characterization is, to the extent possible, to identify biologic mechanisms, risk factors, and features that are related to reporting behaviour.

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