1. User Guide
  2. Integrate Oracle InForm with Oracle Argus Safety
  3. Add rules to forms for sending data to Argus Safety
  4. Add required rules to the Adverse Event form
  5. Send the Reportable or Serious item to Oracle Argus Safety only when the Oracle InForm user marks it as Ready-to-Send

Send the Reportable or Serious item to Oracle Argus Safety only when the Oracle InForm user marks it as Ready-to-Send

Note:

If you have both Adverse Event form(s) and a Safety Case form, the rule goes on the Safety Case form.
Item Description
When to use

This rule is typically used when you want to indicate explicitly that the safety event information is ready to be sent to Oracle Argus Safety.

You might use this rule when:
  • The Oracle InForm user wants to make sure that any related labs or concomitant medications have been entered before transmitting the AE to Oracle Argus Safety.
  • A review process is in place.
This rule can be used for a combined AE/Safety Case form or for a separate Safety Case form.
Purpose

Ensures that a safety event, marked as Reportable or Serious, is sent to Oracle Argus Safety only when explicitly marked as Ready-to-Send.

Note:

The case will be sent automatically after 24 hours of initial form submission.
Triggering controls
Y or N codelists for the following:
  • Item marking the safety event ready to send (the ready-to-send item).
  • Item marking the safety event reportable (the reportable item).
  • Item marking the safety event serious (the serious item).
Action when rule is triggered
Reportable or Serious item value is Y, and Ready-to-Send item value is Y:
  • Message—IsReadyToSend
  • Result—The safety event data is sent to Argus Safety immediately.
Reportable or Serious item value is Y, but Ready-to-Send item value is N:
  • Message—IsReportableOrSerious
  • Result—The safety event data is sent to Oracle Argus Safety after an interval that is configured in Oracle InForm Publisher.
Ready-to-Send item value is Y, but neither the Reportable nor the Serious item value is Y:
  • Message—IsCancelled
  • Result—The _SaveToDB function does one of the following:
    • Cancels a pending submission.
    • Sends a nullification submission to Oracle Argus Safety if the safety event was submitted previously.
    • Does nothing if the safety event was not marked Reportable or Serious previously.
Rule expression 
(!this.AEInfoSct.IsSerious.Empty && this.AEInfoSct.IsSerious.Value != 'N')|| (!this.AEInfoSct.IsReportable.Empty && this.AEInfoSct.IsReportable.Value != 'N')? (!this.AEInfoSct.IsReadyToSubmit.Empty && this.AEInfoSct.IsReadyToSubmit.Value != 'N') ? _SaveToDb("SafetyConstants.IsReadyToSend", GetTrialName()) : _ SaveToDb("SafetyConstants.IsReportableOrSerious", GetTrialName()): _ SaveToDb("SafetyConstants.IsCancelled", GetTrialName()

Parent topic: Add required rules to the Adverse Event form