Do this first: Include items that you map once in the Safety

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. So if you map Lab Name and Test Date to LabLocal and LabCentral, both Name and Date need to put the forms in the same order.

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.
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.