Enable Adverse Event Watchlists

Learn how to update your Vault’s configuration to enable the adverse event watchlists feature.

About the Feature

Adverse event watchlists were added in Vault Safety 19R3.2 Limited Release, and 20R1 General Release. Upgraded Vaults must perform the following configuration to enable this feature.

An additional watchlist feature was added to Vault Safety in 22R1 to allow administrators to configure seriousness criteria on a watchlist and configure watchlists independent of Products or Studies. You must perform these configurations to enable this feature.

You must also ensure the Watchlist layout is updated to match the settings described in this article.

Configuration Checks for All Vaults

Go to Configuration > Objects > Watchlist. From the Layouts tab, open the Watchlist Detail Page Layout.

Ensure the Watchlist Detail Page Layout matches the settings and order described in the following table that lists the fields or columns each section should have. Add/remove fields or columns to match the list.

Section Settings Fields/Columns
Details
  • Type: Detail Form
  • Section Label: Details
  • Section Name: details__c
  • Section Layout: Detail Form - One Column
  • Organization
  • Name
  • Watchlist Tag
  • Study
  • Study Product
  • Product
  • MedDRA Version
  • space
Updates to Case Fields
  • Type: Detail Form
  • Section Label: Updates to Case Fields
  • Section Name: updates_to_case_fields__c
  • Section Layout: Detail Form - One Column
  • Expedited
  • Default Seriousness
MedDRA Terms
  • Type: Related Object
  • Related Object: MedDRA Criteria
  • Section Label: MedDRA Terms
  • Section Name: meddra_criteria__c
  • Creation Option: Create record in pop-up dialog
  • Criteria VQL:
    object_type__vr.api_name__v = 'watchlist_criteria__v'
  • Name
  • MedDRA Term
  • Description
Workflow Timeline Default Settings
System Information
  • Type: Detail Form
  • Section Label: System Information
  • Section Name: system_information__c
  • Section Layout: Detail Form - Two Columns
  • Last Modified Date
  • Last Modified By
  • Space
  • Created Date
  • Created By
  • API Name

(20R1) Enable Adverse Event Watchlists

You must update the fields, layout, and layout rules for the Watchlist object.

Update the Watchlist Object

To edit the Watchlist object, in the Admin area, go to Configuration > Objects > Watchlist.

Fields

On the Watchlist > Fields tab, update the following fields:

Field Changes
Expedited Select Display in default lists and hovercards.
MedDRA Version Select Display in default lists and hovercards.
Organization Select Display in default lists and hovercards.
Product
  • Select Display in default lists and hovercards.
  • Under Constrain Records in Referenced Object, add the VQL criteria
    organization__v = {{this.organization__v}}
Study
  • Select Display in default lists and hovercards.
  • Under Constrain Records in Referenced Object, add the VQL criteria
    organization__v = {{this.organization__v}}
Study Product Select Display in default lists and hovercards.
Watchlist Tag Select Display in default lists and hovercards.

List Layout

On the Watchlist > List Layout tab, edit the List Layout to match the following order:

  • Organization
  • Product
  • Study
  • Study Product
  • Expedited
  • Watchlist Tag
  • MedDRA Version

Detail Page Layout Rules

Go to Watchlist > Layouts > Watchlist Detail Page Layout > Layout Rules, and then add the following layout rules:

Rule Label Hide the following Layout Items IF this Layout Rule Expression is TRUE
Product Selected
  • Type: Fields
  • Values: Study, Study Product
 not(isBlank(product__vr.name__v))
Study Selected
  • Type: Fields
  • Values: Product
 not(isBlank(study__vr.name__v))

Update the Case Entry Workflow

Go to Object Workflows > Case Entry, and then update the Requires Medical Review workflow step to match the following settings:

  • Type: Decision
  • Next Steps: Determined by the rules below
  • Rule 1: If Expedited = Yes then Start Medical Review
  • Else Rule 2: If Watchlist Tags includes AESI then Start Medical Review
  • Else: Approval (Non-Expedited)

Medical Review Decision in Case Entry Workflow

(22R1) Enable Always Serious and Product or Study-Independent Watchlists

You must update the layout and validation rules for the Watchlist object.

Update the Validation Rules for the Watchlist Object

To edit the Watchlist object, in the Admin area, go to Configuration > Objects > Watchlist.

  1. Go to the Validation Rules tab.
  2. Select the Product or Study is Mandatory rule.
  3. Update the Validation Expression field to the following expressions:
     
    (not(isBlank(product__vr.name__v)) && (isBlank(study__vr.name__v)) ||
     
    ((isBlank(product__vr.name__v))) && not(isBlank(study__vr.name__v)) ||
     
    ((isBlank(product__vr.name__v))) && (isBlank(study__vr.name__v)))
     
    Watchlist Object Validation Rules
  4. Save the page.

Resources

Once you have enabled this feature, Configure Adverse Event Watchlists provides more information about how to use it.