Enable Opening Safety Investigations from Literature Articles

Learn how to configure your Vault so users can open a Safety Investigation directly from a Literature Article.

About the Feature

With the 24R3 release, users can create a Safety Investigation for each Product Family on a Literature Article with an independent Investigation Review Outcome that requires further action. Vault Safety creates a Literature Data record to relate the Safety Investigation to the Literature Article. This allows for a Safety Investigation to be linked to multiple Literature Articles and Products in Literature Articles.

After you have configured this feature, see Signal Management and Create Safety Investigations for more information.

Update the Literature Data Object

To configure the Literature Data object, update the fields on the layout and reorder the List Layout. To complete these procedures, navigate to Admin > Configuration > Objects > Literature Data.

Update the Layout

To update the Literature Data layout, navigate to the Layouts tab and use one (1) of the following methods:

  • Copy the applicable standard layout and set the new custom layout as the default. Delete other existing custom layouts, if any.
  • Select the existing Literature Data Detail Page Layout and add the following fields to the Details section:
    • Literature Article
    • Title of Article
    • Product Family
    • Safety Investigation
    • Literature Database
    • Database Name
    • Detection Type
    • Reporting Period
    • Product-Event Combination
    • PEC Period
    • MedDRA Term
    • MedDRA Query
    • Current Disposition
    • Current Disposition Date
    • Keywords

Update the List Layout

To update the Literature Data list layout:

  1. Navigate to the List Layout tab and select Reorder.
  2. Drag field names so the list layout appears in the following order:
    • Literature Data Unique Name
    • Product Family
    • MedDRA Term
    • Literature Article
    • Title of Article
    • Abstract
    • Keywords
    • Reporting Period
    • Safety Investigation
  3. Select Save.

Update the Safety Investigation Object Layout

To insert the Literature Data related object section to the Safety Investigation layout:

  1. Navigate to Admin > Configuration > Objects > Safety Investigation > Layouts > Safety Investigation Detail Page Layout.
  2. After the PEC Periods section insert the Literature Data related object section with the following configuration:
    • Related Object: From the drop-down, select Literature Data.
    • Section Name: Enter Literature.
    • Creation Option: Select Create record in pop-up dialog.
  3. Select Done.
  4. (Optional) Edit the default columns to appear as follows:
    • Literature Data Unique Name
    • Product Family
    • MedDRA Term
    • Literature Article
    • Title of Article
    • Keywords
    • Abstract
    • Reporting Period
    • Current Disposition
    • Current Disposition Date
    • Detection Date
  5. Select Done.
  6. Select Save.

Configure the Open Investigation Action on the Literature Article Object

To configure the Open Investigation action, assign the action to the Literature Article object and add the action as a user action to the applicable lifecycle states of the Literature Article Lifecycle object lifecycle.

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 > Signal Management > Objects > Literature Article. We recommend the following level of access:

  • Object Permissions: Grant Read, Create, Edit, and Delete permissions.
  • Object Action Permissions: For the Open Investigation action, grant View and Execute permissions.