About the Feature
Case-level relatedness was added in Vault Safety 20R1.
This feature introduces the ability to view the Relatedness for the primary assessment at the Case-level.
In addition, new and revised Case Assessments and Cases that meet the appropriate seriousness criteria are automatically tagged as a SUSAR or SAE to aid in ad-hoc reports and data analysis.
Once this feature is enabled, for more information about this feature, refer to the following pages:
- Enter Case Data describes the Relatedness field and the new SUSAR and SAE tags.
- Enter Adverse Event Report Information describes the Reporter Assessment Result field.
- Enter a Case Assessment describes how the Causality Established field on the Assessment Result object rolls up to the Case Relatedness field
Update the Case Object
You must update Case page layouts and hovercard display settings.
To edit the Case object, go to Configuration > Objects > Case.
Page Layouts
Go to the Case > Page Layouts tab and update the following page layouts.
1. AER Detail Page Layout
In the AER Detail Page Layout, add the Reporter Assessment Result field to the Reporter section.
2. Case Page Layout
In the Case Page Layout, make the following updates:
- In the Details section, add the Relatedness field.
- If not already present on the layout, add a related object section for the Assessment object.
- In the Assessments section, add the Assessment Tag column to the grid.
- If not already present on the layout, add a related object section for the Assessment Result object.
Update Case Intake Actions Permission Sets
- Go to Users & Groups > Permission Sets, and then open the Case Intake Actions permission set.
- In the Case Intake Actions permission set, go to Objects > Case.
- Under Object Field Permissions, enable the Edit permission for Reporter Assessment Result.
Display Relatedness in Case Hovercard
- Go to Objects > Case > Fields, and then open the Relatedness field.
- Make sure the Display in default lists and hovercards option is enabled.
Update Controlled Vocabularies
- Enable Controlled Vocabulary User Actions to be able to activate and deactivate Controlled Vocabulary records.
- Deactivate any records with the E2B Default Values field set to No or Null, for the following Controlled Vocabularies types:
- Case Assessment Method
- Case Assessment Result
- Case Assessment Source
Note Deactivating non-E2B default Controlled Vocabularies is optional and may vary between vaults, depending on each customer's preferred configuration. The Controlled Vocabularies with the E2B Default Values field set to Yes should not be modified.
Configure Controlled Vocabularies provides more information on managing Controlled Vocabulary records.
Update Triage Workflows
In Vault Safety 19R3 and earlier, the SUSAR and SAE tags were set through Triage workflows. In 20R1 and later, the system updates the SUSAR and SAE tags automatically when a Case meets SUSAR or SAE criteria. However, you must update your vault’s workflow configuration to make this change visible.
Go to Configuration > Object Workflows, and then perform the following steps on the Case Triage and Case Triage (Follow-Up) workflows.
- In both the Case Triage and Case Triage (Follow-Up) workflows, remove the following workflow steps:
- Decision: Is Study?
- Update Record Field: SUSAR
- Update Record Field: SAE
- Link the steps that were before and after the deleted steps to make sure the workflow is valid.
For example, in the Case Triage workflow you may need to update the Set Expedited step to set the next step to Start Case Entry.