1. User Guide
  2. Integrate Oracle InForm with Oracle Argus Safety
  3. Add rules to forms for sending data to Argus Safety
  4. Add rules to the Safety Case form
  5. (Required) Send a query if no adverse events are on the Safety Case form

(Required) Send a query if no adverse events are on the Safety Case form

Use this rule in case the Oracle InForm site user completes a Safety Case form and then removes all related adverse events from the dynamic grid. The Adverse Event forms themselves may still exist but are irrelevant. Because there are no adverse events on the Safety Case form, no adverse events would be a part of the Oracle Argus Safety case. An Oracle Argus Safety case needs at least one adverse event to be a valid case.

  • This rule should be written on an item in a flat section on the Safety Case form. In this example, it is the narrative field.
  • It is preferable to have this rule attached to an item in a flat section that is at the top of the CRF, if one exists. Safety Case forms can be quite long and, if the query is at the bottom of the form, the site user could miss the fact that there is a query open.
  • The query should instruct the site user to either: 1) add an AE/SAE (if the case is still valid) or 2) delete the Safety Case form itself (if the case should be nullified).
Item Description
When to use If you are using a Safety Case form with an add entry section to add adverse events.
Purpose

If you clear the sequence ID of the only itemset or if you delete the only itemset, nothing will be sent to Oracle Argus Safety to update the case. An error message is generated in Oracle InForm Publisher, but not displayed to the site user.

Clearing the AE sequence number field in a Safety Case form, when an AE form is associated with the Safety Case form, should trigger a nullification message in Oracle Argus Safety, not an error message from Oracle InForm Publisher. This rule should be set up to open a query to the site user when there are no adverse events present in the itemset on the Safety Case form.

Triggering controls All sequence ID fields in the itemset are blank.
Action when rule is triggered Opens a query.
Rule expression

The rule below generates a query if a form is submitted without an entry in the fields that trigger transmission of safety data.

evaluate on Form Submission

value = !this.eSAE.Current().sctSAE001_03NAR.SAENARR_1.Empty && this.eSAE.sctSAE001_02AE.SAEAESPID.Values.Length < 1

when value is true
                issue query on this.eSAE.Current().sctSAE001_03NAR.SAENARR_1: Missing eSAE info. Please review and update if needed.

Parent topic: Add rules to the Safety Case form