Design the Adverse Event form

An Adverse Event form is a form designed to collect adverse event data. InForm sends the collected data to Argus Safety.

When designing an Adverse Event form, consider that:

You can map only one item in a repeating section on the AE form to the Subject_AdverseEvent narrative. The text in this item will appear at the beginning of the narrative for each AE selected in the dynamic grid in the order the AE is selected.
When you design control captions that will be used in a dynamic grid (for example, for an item question or codelist label), make sure that they are fully labeled so that the data makes sense in the dynamic grid.
If an in-place revision includes a form or section used as a source form for a dynamic grid section, you must apply the same in-place revision to the dynamic grid section.

Note: Each Argus case includes one study subject only, but it can also be made up of one or multiple adverse events per single case. For more information, see When might an InForm site user include multiple adverse events when sending data to Argus?

To design an Adverse Event form in Central Designer:

At the bottom of the Project Explorer, click the Visit Schedule () button.
Right-click the study event to which you want to add the Adverse Event form to, select New, and select Form.
Enter a Title, RefName, and Description, and click OK.
In the Project Explorer, select the new form, and make sure the Design tab is selected.
In the upper-right above the grid, select the Repeating checkbox.
In the grid, add adverse event items. You must include a date/time item to capture the onset date of the adverse event.
Define the trigger questions used to activate rules.
The following questions are used to trigger rules to initiate the transmission of the adverse event data:
- Serious (the item will be reported). The question might be: Was this a Serious Adverse Event?
- Reportable (the item is not serious but should still be reported). The question might be: Should this event be reported?
For each of these items, follow these guidelines:
- For Type, select Yes No Item. This type includes a built-in codelist that allows the user to select Yes or No.
- Enter Title, RefName, Question, and Short Question. For example: Reportable, Report, Is this a non-serious event, but still should be reported?, and Report?
- Select the Item Req checkbox.