Enable Auto-Ranking Case Adverse Events

Learn how to configure ranking rules and automatic Case Adverse Event ranking in your Vault.

About the Feature

With the 25R2 release, Veeva Safety introduces automatic ranking of Case Adverse Events based on your configured ranking priority. This feature supports identifying the primary event and ensuring that case tags and roll-ups accurately reflect rankings. You can configure your Vault to rank using either of the following priority orders:

• 1. Seriousness 2. Relatedness 3. Expectedness (default)
• 1. Relatedness 2. Seriousness 3. Expectedness

When events are tied, Vault applies a fixed sequence of tie-breakers using outcome, severity, CTCAE Grade, and then creation date. When complete, Vault populates the Auto-Rank and Rank fields. Users can override the Rank. Any manual change results in Vault setting the Event Rank (Status) field to Overridden. Based on your business process, you can configure automatic ranking through user action or entry action.

Additionally, this feature introduces the Overall Case Seriousness field to the Case object, which rolls up the most critical seriousness value across all adverse events, regardless of rank, on a given case.

After you have configured this feature, see How Case Adverse Events are Auto-Ranked and Enter Case Data for more information.

Update General Settings

To define the priority values Vault uses to rank Case Adverse Events:

1. Navigate to Admin > Settings > Safety General Settings.
2. Select Edit.
3. In the Auto-calculation Settings section, select an option in the Adverse Event Ranking Order drop-down.
4. Select Save.

Configure the Case Object

To configure the Case object, you must configure the Auto-Rank Case Adverse Events action and update the layout.

Configure the Auto-Rank Case Adverse Events Action

To configure the Auto-Rank Case Adverse Events action, assign the action to the Case object and do the following, according to your business process:

• Add the action as a user action to applicable states of the Case Lifecycle object lifecycle.
• Add the action as an entry action for applicable Case Lifecycle object lifecycle states. We do not recommend configuring the entry action during promotion to initial or follow-up Case.

Update the Case Layout

Add the following fields to Case object layouts for the Case and Imported Case object types:

• Overall Case Seriousness
• Event Rank (Status)

Update the Case Adverse Event Layout

Add the Auto-Rank field to the Case Adverse Event Detail Page Layout of the Case Adverse Event object.