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Include items you want to monitor for changes to the Safety_Significant data series
The Safety_Significant data set is an empty data set in which you create the data series and mappings for items that are monitored for changes after initial transmission to determine whether follow-up for safety integration is needed. For example, if an AE item containing data about a reaction recurrence is mapped to a data series in the Safety_Significant data set, a follow-up for safety integration is triggered when a user changes the data in the reaction recurrence item.
Note: The data series in the Safety_Significant data set must have the same aliases as the corresponding data series in the message body data sets. Therefore, copy and pasting data series from the message body data sets into the Safety_Significant data set is recommended.
