With the 26R2 release, for Veeva SafetyDocs and Veeva Safety Signal, Vault can now create Signal Reporting Periods for a Signal Product Profile based on a configured schedule. This automation reduces manual effort and tracking for routine signal surveillance reviews. After you have configured this feature, see the following articles for more information: 

Update Object Layouts

Update the following object layouts

Signal Product Profile

To update the Signal Product Profile layout: 

  1. Insert the Schedule detail form section.
  2. In the Schedule section, add the following fields:
    • Schedule
    • Schedule Start Date
    • Schedule Initiated By
    • Schedule Initiated Date/Time
    • Schedule Terminated Date/Time
  3. Set the Schedule and Schedule Start Date fields to required by hovering next to the fields and selecting the Edit icon. Then, select Display As Required and select Done.
  4. In the Signal Reporting Periods section, edit the default columns to include:
    • Review Type
    • Start Date
    • End Date
    • Lifecycle State
    • Previous Signal Reporting Period
    • Next Signal Reporting Period
  5. After the Details section, insert the Schedule Recurrence related object section as follows:
    • Section Label: Enter Signal Review Schedule Recurrences
    • Creation Option: Select Prevent record creation
      Vault will create the record when users trigger the Schedule Signal Review action.
  6. In the Schedule Recurrence section, edit the default columns to include: 
    • Name
    • Schedule
    • Start Date
    • Lifecycle State

Signal Reporting Period

To update the Signal Reporting Period layout, in the Details section, add the following fields:

  • Review Type
  • Previous Signal Reporting Period
  • Next Signal Reporting Period

Configure the Signal Review Actions on Signal Product Profile

You can configure the Schedule Signal Review and Cancel Scheduled Signal Review actions as part of a workflow and then add these actions as user actions on the Signal Product Profile object lifecycle; this configuration displays the actions in the Workflow Actions menu (workflow-actions-menu). Alternatively, assign the actions to the Signal Product Profile object and add them as a user action to the applicable states of the Signal Product Profile object lifecycle using the following table: 

Condition Type Condition Allow the following actions Action Label
All conditions are met Schedule Initiated Date/Time > is blank Schedule Signal Review Schedule Signal Review
Schedule Start Date > is not blank
All conditions are met Schedule Initiated Date/Time > is not blank Cancel Scheduled Signal Review Cancel Scheduled Signal Review
Schedule Terminated Date/Time > is blank

Update the Signal Reporting Period Object Lifecycle

This section applies only to Vaults with Veeva Safety Signal enabled. For the Signal Reporting Period object lifecycle, associate the Queued state with the Queued state type.

Grant Permissions

Ensure your permission sets are updated to grant the appropriate level of access for users to objects and fields according to your organization’s process. Manage object permissions from Admin > Users & Groups > Permission Sets > [Permission Set] > Objects.

We recommend granting the following object and field permissions:

Object Fields Object Permissions
Schedule N/A
  • Read
Schedule Component N/A
  • Read
Schedule Recurrence of type Signal Product Profile Recurrence N/A
  • Read
Scheduled Event N/A
  • Read
Scheduler Exception N/A
  • Read
Signal Product Profile
  • Schedule
  • Schedule Start Date
  • Schedule Initiated By
  • Schedule Initiated Date/Time
  • Schedule Terminated Date/Time
  • Read
  • Edit
Signal Reporting Period
  • Review Type
  • Previous Signal Reporting Period
  • Next Signal Reporting Period
  • Read
  • Edit