Include items that you map once in the Safety_Config data series

Add all items and forms to be sent to Oracle Argus Safety to the Safety_Config data set. This tells Oracle InForm Publisher where the items are located.

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.

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.

Note:

You don't need this data series if you are using InclusionTargets. For more information, see Map a form to multiple dynamic grids.