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Examples of Safety Tables Included in Clinical Study Reports

5 Examples of Safety Tables Included in Clinical Study Reports [Pg.106]

Several summary tables are commonly presented to report safety data. Two examples of typical formats are provided here. Table 5.2 shows the format for the overall summary of adverse events falling within several adverse event categories. It is actually a table shell that is prepared by medical writers in advance of the study s results being available preparation in advance of the availability of the data saves time during the preparation of the clinical study report once the data are available. [Pg.106]




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