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Do this first: Include items that you map once in the Safety_Config data series
Add all items and forms to be sent to Argus to the Safety_Config data set. This tells InForm Publisher where the items are, but doesn't extract the data.
After you add an item to a data series in a data mapping, you can specify the circumstances for which the item is mapped to the data series. For example, an item that appears on several forms in a study can be added to a data series, but you might want to analyze data collected for the item only when it appears on a specific form. In that situation, you can map the item to the data series for the specific form.
Note: You can map multiple items to the same data series, and you can map similar items from different forms to the same data series in a repeating data set. For example, you can map items from a Lab Local and a Lab Central form to the same data series in the Subject_LabTest data set. When you do this, the safety event transmission treats the items as coming from different instances, so the transmission message contains a different element for each form. To do this, make a copy of the entire dataset. Then map one dataset to the LabLocal form and the other to the LabCentral form.
Data Series Title |
Description |
|---|---|
Any AE Form Control |
Control used to identify the Adverse Event form. Map this data series to any item on the Adverse Event form. Required. |
Any SE Form Control |
Control used to identify the Safety Case form in a study design with separate Adverse Event and Safety Case forms. Map this data series to any item on the Safety Case form. Required in a design with separate Adverse Event and Safety Case forms. |
SE Current Status Control |
Item used to store the accepted or rejected status of the most recent safety transmission file. Typically this item is on the Adverse Event or Safety Case form. |
SE Related AE Sequence Number Control |
Map the item on the Safety Case form that collects the sequence ID of the Adverse Event form. If this is mapped to an item in a repeating itemset, then time frames will not be used for related adverse events. Unnecessary when using dynamic grids. |
AE Start Date Control |
Onset date of the adverse event. This data series is used to identify by date range the related safety event data that appears on other forms. |
SafetyCaseAEDynamicGrid |
Control used to identify the dynamic grid where the adverse events that will be part of the safety case will be selected. |
