Enable the Signal Alert Rule Engine

Learn how to configure your Vault to run the Signal Alert Rule Engine.

About the Feature

With the 25R1 release, you can use the Signal Alert Rule Engine to determine whether a Product-Event Combination (PEC) meets the criteria for a potential signal and requires further review. For signal detection, the Signal Alert Rule Engine runs predefined Signal Alert Rule Sets and Signal Alert Rules against Statistical Data records.

After you have configured this feature, see the following resources for next steps:

• Manage Signal Product Profiles
• Configure Signal Alerts
• Run & Review Signal Alerts

Configure Object Layouts

Create new custom layouts and update the list layouts for the following objects:

• Signal Alert Rule
• Signal Alert Rule Set
• Signal Alert Rule Set Product Profile
• Signal Product Profile

You must also update the Signal Reporting Period object layout.

Navigate to Admin > Configuration > Objects.

Configure the Signal Alert Rule Layout

Before creating the Signal Alert Rule object layout, update the list layout:

1. Navigate to the Signal Alert Rule Set object and select the List Layouts tab.
2. Select Reorder.
3. Drag field names so the list layout appears in the following order:
   • Signal Alert Rule Set
   • Signal Alert Rule Name
   • Description
   • Expression
   • Alert Category
   • API Name
4. Select Save.

To create the Signal Alert Rule object layout:

1. Select the Layouts tab.
2. Select Create.
3. In the Add Layout dialog, enter a name for the layout in the Layout Label field, for example, Signal Alert Rule Detail Page Layout.
4. Select Done.
5. On the new object layout, add the following fields to the Details section:
   • Signal Alert Rule Set
   • Signal Alert Rule Name
   • Description
   • Expression
   • API Name
6. Select Save.

Configure the Signal Alert Rule Set Layout

Before creating the Signal Alert Rule Set object layout, update the list layout:

1. Navigate to the Signal Alert Rule Set object and select the List Layouts tab.
2. Select Reorder.
3. Drag field names so the list layout appears in the following order:
   • Signal Alert Rule Set Name
   • Description
   • API Name
4. Select Save.

To create the Signal Alert Rule Set object layout:

1. Select the Layouts tab.
2. Select Create.
3. In the Add Layout dialog, enter a name for the layout in the Layout Label field, for example, Signal Alert Rule Set Detail Page Layout.
4. Select Done.
5. On the new object layout, in the Details section, add the following fields:
   • Signal Alert Rule Set Name
   • API Name
6. Use the following table to insert related object sections and then select Done:

Related Object	Section Label	Creation Option
Signal Alert Rule	Signal Alert Rules	Create record in pop-up dialog
Signal Alert Rule Set Product Profile	Related Signal Product Profiles	Prevent record addition

Optionally, edit the default columns:

Section	Default Columns
Signal Alert Rules	Signal Alert Rule Name Description Expression Alert Category
Related Signal Product Profiles	Name Signal Product Profile > Product Family Last Executed Date

Configure the Signal Alert Rule Set Product Profile Layout

To create the Signal Alert Rule Set Product Profile object layout:

1. Navigate to the Signal Alert Rule Set Product Profile object and select the Layouts tab.
2. Select Create.
3. In the Add Layout dialog, enter a name for the layout in the Layout Label field, for example, Signal Alert Rule Set Product Profile Detail Page Layout.
4. Select Done.
5. On the new object layout, add the following fields to the Details section:
   • Name
   • Signal Alert Rule Set
   • Signal Product Profile
6. Select Save.

Configure the Signal Product Profile Layout

Before creating the Signal Product Profile object layout, configure the list layout:

1. Navigate to the Signal Product Profile object and select the List Layouts tab.
2. Select Reorder.
3. Drag field names so the list layout appears in the following order:
   • Organization
   • Profile Name
   • Product Family
   • Source
   • Health Authority Database
4. Select Save.

To create the Signal Product Profile object layout:

1. Select the Layouts tab.
2. Select Create.
3. In the Add Layout dialog, enter a name for the layout in the Layout Label field, for example, Signal Product Profile Detail Page Layout.
4. Select Done.
5. On the new object layout, add the following fields to the Details section:
   • Organization
   • Profile Name
   • Product Family
   • Source
   • Health Authority Database
6. Insert a related object section with the following information:
   • Related Object: Signal Alert Rule Set Product Profile
   • Section Label: Alert Rule Sets
   • Creation Option: Create record in pop-up dialog
7. Select Done.
8. Optional: Edit the default columns to display the following fields:
   • Name
   • Signal Alert Rule Set
   • Signal Alert Rule Set > Description
9. Select Save.

Update the Signal Reporting Period Layout

To update the Signal Reporting Period object layout:

1. Navigate to the Signal Reporting Period object and select the Layouts tab.
2. Select Signal Reporting Period Page Layout.
3. In the Details section, add the Signal Product Profile field.
4. Insert a related object section with the following information:
   • Related Object: Statistical Data
   • Section Label: Statistical Data
   • Creation Option: Prevent record creation
5. Select Done.
6. Optional: Edit the default columns to display the following fields:
   • Statistical Data Unique Name
   • Product Family
   • MedDRA Term
   • Detection Date
   • Alert
   • Alert Category
   • Listed
     Add additional default columns as needed.
7. Select Save.

Update Fields on the Signal Alert Rule Set Object

On the Signal Alert Rule Set object, update the Frequency field to clear the Display in default lists and hovercards checkbox as this field is inactive.

Add the Run Signal Alerts Action to the Signal Reporting Period Object

Add the Run Signal Alerts Runs action to the Signal Reporting Period object so users can manually run the Signal Alert Rule Engine. Leave the Available in All Lifecycle States checkbox unselected.

Configure Object Lifecycles

Navigate to Admin > Configuration > Object Lifecycles to update the following object lifecycles:

• Signal Reporting Period
• Statistical Data

Update the Signal Reporting Period Lifecycle

Update the Signal Reporting Period Lifecycle state types:

1. Navigate to the Signal Reporting Period Lifecycle.
2. In the State Types section, use the table below to associate a state type with the corresponding state:

State Type	State
Error State	Error
Initial State	Active
Ready State	Ready

The names of the Signal Reporting Period Lifecycle states may differ in your Vault depending on your business needs.

Add the Run Signal Alert Rules action to the Signal Reporting Period Lifecycle:

1. In the States section, select the lifecycle state of the Initial state type, for example, Active.
2. Beside the User Actions section, select Edit.
3. Create the following rule
   • Always > Run Signal Alert Rules
     • Action Label: Run Signal Alert Rules
4. Select Save.

Update the Statistical Data Lifecycle

Update the Statistical Data Lifecycle state types:

1. Navigate to the Statistical Data Lifecycle.
2. Use the table below to associate a state type with the corresponding state:

State Type	State
Complete State	Complete
Initial State	Active
Ready State	Ready

The names of the Signal Reporting Period Lifecycle states may differ in your Vault depending on your business needs.

Add the Signal Product Profile Tab

Add the Signal Product Profile tab to the applicable tab collection:

1. Navigate to Admin > Configuration > Tab Collections > [Tab Collection].
2. In the desired tab collection, select Add Tabs.
3. In the Available column, double-click or select Signal Product Profile and use the left/right arrow buttons to add the tab to the Selected column.
4. Select Save.
5. Optional: Select Reorder to reorder the tabs by dragging and dropping.

Grant Permissions

Ensure your permission sets are updated to grant the appropriate level of access for Admins and business 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 Field Permissions	Object Action/Control Permissions
[Applicable Admin Permission Set]	Signal Alert Rule Set	Read Create Edit Delete	Grant all fields the following permissions: Read Edit	Grant All Object Controls the following permission: View
	Signal Alert Rule	Read Create Edit Delete	Grant all fields the following permissions: Read Edit	Grant All Object Controls the following permission: View
	Signal Alert Rule Set Product Profile	Read Create Edit Delete	Grant all fields the following permissions: Read Edit	Grant All Object Controls the following permission: View
	Signal Product Profile	Read Create Edit Delete	Grant all fields the following permissions: Read Edit	Grant All Object Controls the following permission: View
	Signal Reporting Period	Read Create Edit Delete	Grant all fields the following permissions: Read Edit	Grant the Run Signal Alert Rules action the following permissions: View Execute Grant All Object Controls the following permission: View
[Applicable User Permission Set]	Signal Alert Rule Set	Read	Grant all fields the following permission: Read	Grant All Object Controls the following permission: View
	Signal Alert Rule	Optional: Read	Optional: Grant all fields the following permission: Read	Grant All Object Controls the following permission: View
	Signal Alert Rule Set Product Profile	Read	Grant all fields the following permission: Read	Grant All Object Controls the following permission: View
	Signal Product Profile	Read	Grant all fields the following permission: Read	Grant All Object Controls the following permission: View
	Signal Reporting Period	Read Create Edit Delete	Grant all fields the following permissions: Read Edit	Grant All Object Controls the following permission: View

Standard Tab Permissions

In the applicable permission sets, select the Tabs tab and grant View permissions for the Signal Product Profile tab.