Learn how to create custom significance rules to define how Vault identifies significant and urgent Inbox Items generated by the Safety-EDC Connection. These rules alert users about possible changes to the reporting requirements for a Case.

About Significance Criteria

Your Vault includes standard Significance Criteria, which Vault uses to determine the Significance value for Inbox Items generated from serious adverse events (SAEs) transferred by the Safety-EDC Connection. You can use these standard rules or customize them to support the unique requirements of your organization’s business processes.

For Inbox Items generated by the connection, Vault calculates the Significance value based on which active Significance Criteria return true and, when applicable, generates a follow-up Case. When multiple criteria return true, Vault assigns the highest level of significance met:

  • Initial Case
  • Non-Significant Follow-Up
  • Significant Follow-Up
  • Urgent Significant Follow-Up

Users can review which Significance Criteria Vault evaluated to determine Significance in the Significance Results section of an Inbox Item. Vault recalculates Significance every time it detects an associated follow-up Inbox Item. Users can also manually recalculate Significance using the Rerun Significance Criteria action.

Prerequisite

Before configuring this feature, you must enable Automated Classification of Inbox Item Significance.

Define Significance Criteria

You can use the standard Significance Criteria in your Vault or create new rules that are customized to fit your business needs. You can review the Descriptions of all standard rules to understand the criteria by navigating to Business Admin > Objects > Significance Criteria.

To create custom rules, you can copy the standard record, then update the custom records as needed, or create new records from scratch:

  1. Navigate to Business Admin > Objects > Significance Criteria.
  2. Create the new record as applicable:
    • To create a new rule, select Create.
    • To modify a standard rule, copy the existing record:
      1. From the record’s Action menu, select Change State to Inactive.
      2. From the record’s Action menu, select Copy Record.
  3. Enter or update the Name.
  4. Optional: Enter or update the Description.
  5. Use the Significance Criteria Builder to define when Vault applies the specified Significance value.
  6. Select a Significance value to apply when the Rule Formula returns true.
  7. Enter or update an API Name. For example, case_state_change__c.
  8. Select Save.

Significance Criteria Builder

Use the Significance Criteria Builder to build a formula expression. When a formula returns true, Vault applies the Significance Criteria’s specified Significance value to the generated Inbox Item. The builder supports VQL, the operators and functions in the Vault Formula Reference Guide, certain Safety-specific functions detailed in Create Formula Expressions, and the following Safety significance functions:

For more details about creating formulas, see Creating Formulas in Vault.

VS_SIG_CASE_VALUE

VS_SIG_CASE_VALUE(object_name.field_name, "string_value")

This function returns true if there is a particular value of the specified Case field value. This function includes the following inputs:

  • object_name.field_name: Specifies a Case field.
  • string_value: Specifies the Case field’s value. This can be a display value (to evaluate a specific field value) or an ID (to evaluate a specific record).
Example

The following example returns true if there are multiple Cases with an Organization value of Vault Customer:

VS_SIG_CASE_VALUE(case_version__v.organization__v, "Vault Customer")

VS_SIG_CHANGED

VS_SIG_CASE_VALUE(object_name.field_name)

This function returns true if the values of the specified Inbox Item fields do not match the values of the corresponding Case fields, allowing you to evaluate a change on a new Inbox Item against the existing Case. This function includes the following input:

  • object_name.field_name: Specifies a Case field.
Example

The following example returns true if the Event Reported value of the follow-up Case Adverse Event differs from the corresponding field on the related Case:

VS_SIG_CHANGED(case_adverse_event__v.event_reported__v)

VS_SIG_CHANGED_RECORD

VS_SIG_CHANGED_RECORD(object_name)

This function returns true if any non-system field values displayed on the Case Compare Followup layout for the specified object do not match the values of the corresponding Case, allowing you to evaluate changes from a new Inbox Item against the existing Case. This function includes the following input:

  • object_name: Specifies a Case-related object.
Example

The following example returns true if any values of the follow-up Case Adverse Event differs from the corresponding fields on the related Case:

VS_SIG_CHANGED_RECORD(case_adverse_event__v)

VS_SIG_NEW

VS_SIG_NEW(object_name)

This function returns true if the specified record is new. This function includes the following input:

  • object_name: Specifies a Case-related object.
Example

The following example returns true if there is no existing Case Adverse Event for the Case:

VS_SIG_NEW(case_adverse_event__v)