Create narrative items

Narrative items in the Safety Case form allow Oracle InForm site users to include additional information to provide context on Adverse Events sent to Oracle Argus Safety.

When designing a Safety Case form, decide whether the complete and cumulative narrative must be sent to Oracle Argus Safety with each transmission or whether only the changes since the last submission must be sent.

You can create multiple narrative items for a single Safety Case form.

1. At the bottom of the Project Explorer, click the Items () button, and expand the InForm Items folder.
2. To the right of the Project Explorer, click the New button at the top of the workspace.
3. From the drop-down list, select Text.
4. Enter a Title, RefName, and, optionally, a Description of the item, and click OK.
5. In the Form Editor, go to the Display Override column and select the default display behavior of the item when a layout is generated:
   • ReadOnly—The item is visible but not editable.
   • Editable—The item is visible and editable by any user, regardless of the rights assigned to the user.
   • Hidden—The item is not visible.
   • None—The item is visible to all users, and visible and editable by any user who has the rights to view and/or edit the item.
6. In Study Administration, select the System Settings tab.
7. Go to NarrativeUpdatesOnly and set the value to either:
   • • No(default)―The complete narrative must be sent with each transmission to Oracle Argus Safety (cumulative).
     • Yes―Only narrative data that is new since the last transmission to Oracle Argus Safety will be sent (incremental).

   Note:

   To select Yes, you need at least one ReadOnly narrative item, one Editable narrative item, and one Hidden narrative item so that all narrative updates are properly stored in the Safety Case form. Oracle recommends to add two or three narrative items of each type, since text fields in Oracle InForm are limited to 2,000 characters, while the narrative field in Argus can store up to 10,000 characters.

   To select No, you need to have Editable and ReadOnly fields for the narrative item. By doing this, sites cannot remove any previously entered narrative information.