Enable Safety Signal | Veeva Vault Help

Before you can use Veeva Safety Signal, you must update object layouts, configure actions, and grant permissions. For more information about the Signal application, see Veeva Safety Signal Overview.

Configure Object Layouts

Create new custom layouts and update object layouts as described in the sections below. To access object layouts, navigate to Admin > Configuration > Objects > [Object] > Layouts.

Copy Standard Layouts to Create Custom Layouts

For the following objects, copy the applicable standard layout, set the new custom layout as the default, and delete other existing custom layouts that are no longer needed:

EVDAS eRMR Data
EVDAS eRMR Data Line Listing
EVDAS Line Listing
Signal Calculation
Signal Calculation Run
Signal Calculations Setting
Signal Calculation Mapping
Signal Source
Signal Health Authority Database
Statistical Data
For this object layout, ensure the Details section includes the Safety Investigation field and the Safety Investigation field is displayed in default lists and hovercards.
Workbench View
- Signal View object type
- Filter View object type

For the following SafetyDocs objects, copy the applicable standard layout, set the new custom layout as the default, and delete other existing custom layouts that are no longer needed:

Literature Data
PEC Period
Product-Event Combination
Reporting Period
Safety Investigation

Note: To access SafetyDocs objects, you must obtain a SafetyDocs license.

Update the Workbench View Object Principal View Object Type Layout

To update the Workbench View object Principal View object type layout:

Select the Principal View Detail Page Layout.
Ensure the Properties section includes the following fields:
- Name
- API Name
- Description
- Sortable by Row Number
After the Properties section, insert the SQL Editor related object section.
After the SQL Editor section, insert the Workbench View Column related object section with the following information:
- Section Label: Enter View Columns.
- Section Name: Enter view_columns.
- Creation Option: Select Create record in pop-up dialog.
In the View Columns section, edit the default columns to display:
- Name
- Column Type
- Picklist Reference
- Safety Object Reference
- Safety Object Constraint
- API Name
After the View Columns section, insert the Filters control section with the Slider () icon.
After the Filters section, insert the Run Preview control section with the Slider icon.

Update the Workbench View Column Object Layout

To update the Workbench View Column object layout, select the Workbench View Column Detail Page Layout and ensure the Details section includes the following fields:

Name
API Name
Column Type
View
Picklist control field with the Slider icon
Safety Object Reference
Safety Object Constraint

Update the Workbench View Dependency Object Layout

To update the Workbench View Dependency object layout, select the Workbench View Dependency Detail Page Layout and ensure the Details section includes the following fields:

View
Dependent View

Include the Statistical Data Section on Object Layouts

To ensure the Safety Investigation and Signal Reporting Period object layouts include the Statistical Data section, use one of the following methods:

Copy the applicable standard layout, set the new custom layout as the default, and delete other existing custom layouts that are no longer needed.
Insert the Statistical Data related object section to the existing object layout:
1. Select the applicable object layout.
2. Insert a Statistical Data related object section with the following information:
  - Section Label: Enter Statistical Data.
  - Section Name: Enter statistical_data.
3. Select Done.
4. Optional: Edit the default columns to appear as follows:
  - Statistical Data Unique Name
  - Product Family
  - MedDRA Term
  - Alert
  - Listed
  - EB05
  - New All
  - Cumulative All
  - New Fatal
  - Cumulative Fatal
  - New Serious
  - Cumulative Serious
  - New Spontaneous
  - Cumulative Spontaneous
  - Current Disposition
  - Current Disposition Date
  - Previous Period Disposition
5. Select Save.

Update the Statistical Data Object

To update the Statistical Data object, navigate to Admin > Configuration > Objects > Statistical Data and update field settings and the list layout.

Update Fields

To update the Display in default lists and hovercards setting for Statistical Data object fields:

Navigate to the Fields tab.
For the following fields, select the Display in default lists and hovercards checkbox:
- Lifecycle State
- Safety Investigation
For the Source field, clear the Display in default lists and hovercards checkbox.

Update the List Layout

To update the Statistical Data list layout:

Navigate to the List Layout tab and select Reorder.
Drag field names so the list layout appears in the following order:
- Statistical Data Unique Name
- Product Family
- MedDRA Term
- Alert
- Listed
- EB05
- New All
- Cumulative All
- New Fatal
- Cumulative Fatal
- New Serious
- Cumulative Serious
- New Spontaneous
- Cumulative Spontaneous
- Current Disposition
- Current Disposition Date
- Previous Period Disposition
- Previous Period Disposition Date
- Reporting Period
- Detection Date
- Safety Investigation
- Detection Type
- Lifecycle State
Select Save.

Configure Actions on the Signal Calculation Run Object

To configure actions on the Signal Calculation Run object:

Assign the following actions to the Signal Calculation Run object:
- Signal Run: For the Label, enter Run Calculation.
- Create Statistical Data: For the Label, enter Create Statistical Data.
Add the actions as user actions to the applicable states of the Signal Calculation Run Lifecycle object lifecycle.

Grant Permissions

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

Admin & User Permissions

In the applicable permission sets, select the Objects tab and use the table below to grant permissions:

Permission Set	Object	Object Permissions	Object Type/Action/Control	Object Type/Action/Control Permissions
[Applicable Admin Permission Set]	Workbench View	Read Create Edit Delete	Object types: Principal View Signal View Filter View Object controls: Filters Run Preview	View
	Workbench View Dependency	Read Create Edit Delete	N/A	N/A
	Workbench View Column	Read Create Edit Delete	Object control: Picklist	View
	Signal Calculation	Read Create Edit Delete	N/A	N/A
	Signal Calculation Mapping	Read Create Edit Delete	N/A	N/A
	Signal Calculation Run	Read Create Edit Delete	Object controls: Create Statistical Data Signal Run	Execute
	Signal Calculation Run	Read Create Edit Delete	Object controls: Filters Run Preview	View
	Signal Calculations Setting	Read Create Edit Delete	N/A	N/A
	Statistical Data	Read Create Edit Delete	N/A	N/A
[Applicable User Permission Set]	Signal Calculation Run	Read Create Edit Delete	Object actions: Signal Run Create Statistical Data	Execute
	Signal Calculation Run	Read Create Edit Delete	Object actions: Filters Run Preview	View
	Statistical Data	Read Create Edit Delete	Object action: Open Safety Investigation	Execute

Signal Health Authority Database Permissions

In the Signal Management permission set, select the Objects tab and grant Read, Create, and Edit permissions for the Signal Health Authority Database object.

Standard Tab Permissions

In the applicable permission sets, select the Tabs tab and grant View permission for the following tabs:

Statistical Data
EVDAS eRMR Data
Literature Data

Activate Standard Signal Sources

You must make the following standard signal sources active:

Safety Database
Health Authority
Literature

To do this:

Navigate to Business Admin > Objects > Signal Sources.
From the All Actions menu next to a source, select Change State to Active.
Repeat these steps for the required sources.

If you do not see the Change State to Active action, you must add the action as a user action on the Inactive state of the Signal Source Lifecycle object lifecycle.