Enable Signal Detection Plans

With the 26R2 release, you can use Signal Detection Plans to monitor product safety in a centralized area and to define the methodology for performing signal detection and review scope for a Product, Product Family, or Aggregate Reporting Group.

Overview

Complete the following procedures to configure Signal Detection Plans in your Vault:

  1. Update the default object type for Signal Activity.
  2. Update object layouts.
  3. Update object lifecycles. 
  4. Update atomic security. 
  5. Grant permissions. 
  6. Activate document types. 
  7. Optional: Configure tabs. 

Update Default Object Type for Signal Activity

We recommend making the Signal Activity Quantitative Review object type the default on the Signal Activity object: 

  1. Navigate to Admin > Configuration > Objects > Signal Activity. 
  2. Select Edit.
  3. Set the Default Object Type field to Quantitative Review.
  4. Select Save.
  5. Navigate to the Object Types tab. 
  6. Select Base Signal Activity.
  7. Select Edit.
  8. Set the Status field to Inactive.  
  9. Select Save.

Update Object Layouts

Configure the following object layouts: 

Update the Signal Product Tier Layout

To update the Signal Product Tier object layout, insert the following related object sections:

Related Object Section Label Creation Option
Signal Activity Enter Activities Select Create record in new page
Signal Activity Data Source Enter Data Sources Select Create record in pop-up dialog
Signal Activity Alert Rule Set Enter Signal Alert Rule Sets Select Create record in pop-up dialog
Signal Activity Case Routing Criteria Enter Case Routing Criteria Select Create record in pop-up dialog
Signal Detection Plan Enter Detection Plans Select Create record in new page

Update the Signal Detection Plan Layout

To update the Signal Detection Plan object: 

  1. Navigate to Admin > Configuration > Objects > Signal Detection Plan > List Layout and reorder the fields as follows:
    • Name
    • Description
    • Aggregate Reporting Group
    • Product Family
    • Therapeutic Area
    • Tier
    • Plan Version
    • Plan Version Effective Date
    • Plan Version Summary
  2. Navigate to the Layouts tab and select the applicable layout. 
  3. Add the following pages:
    • Plan Details
    • In Effect
  4. On the In Effect page, insert the following related object sections: 
    • Signal Product Profiles
    • Signal Reporting Periods
      • For the Creation Option, select Prevent record creation
  5. After the Signal Reporting Periods section, insert a detail form section as follows: 
    • Section Label: Enter System
    • Section Layout: Select Detail Form - Two Columns
  6. Ensure the System section includes the ID field. If the layout does not include the ID field, you will not be able to update the Plan Version Summary field.
  7. On the Plan Details page, edit the Details section name to Plan Details. 
  8. Ensure the Plan Details section includes the following fields:
    • Name
    • Description
    • Plan Version
    • Plan Version Effective Date
    • Plan Version Summary
    • Plan End Date
    • Plan Inactivation Reason
  9. After the Plan Details section, insert a detail form section as follows: 
    • Section Label: Enter Product Details
    • Section Layout: Select Detail Form - One Column
  10. Add the following fields to the Product Details section: 
    • Aggregate Reporting Group
    • Product Family
    • Therapeutic Area
    • Tier
    • Tier Override Reason
    • Product Surveillance Start Date
    • Product Surveillance End Date
  11. After the Product Details section, insert related object sections using the following table and then select Save: 
Related Object Section Label Creation Option
Signal Activity Enter Activities Select Create record in new page
Signal Activity Data Source Enter Data Sources Select Create record in pop-up dialog
Signal Activity Product Identifiers (your Vault must be licensed for Veeva Safety Signal) Enter Product Identifiers Select Create record in pop-up dialog
Signal Activity Alert Rule Set (your Vault must be licensed for (Veeva Safety Signal) Enter Alert Rule Sets Select Create record in pop-up dialog
Signal Activity Case Routing Criteria Enter Case Routing Criteria Select Create record in pop-up dialog
Signal Detection Plan Signature Enter Signatures Select Create record in new page

Optionally, to create Signal Detection Plans for Products in multiple Therapeutic Areas that share common strategies, navigate to the Fields tab and select Allow user to select multiple values for the Therapeutic Area field.

Update the Signal Detection Plan Signature Layout

To update the Signal Detection Plan Signature object layout, ensure the Details section includes the following fields: 

  • Status
  • Signature Name
  • Signer
  • Signature Time
  • Signed Record

Update the Signal Activity Layout

Navigate to Admin > Configuration > Objects > Signal Activity > List Layout and reorder the fields as follows: 

  • Name
  • Description
  • Signal Detection Plan
  • Aggregate Reporting Group
  • Product Family
  • Tier
  • Activity Schedule
  • Schedule Start Date
  • Case States to Include
  • Activity Review Due in Days
  • Default Workbench Report Set
  • Default Calculations Setting
  • Default Workbench Dashboard
  • Signal Product Profile

Optionally, you can navigate to the Fields tab and select Allow user to select multiple values for the Case States to Include field depending on your business needs.

Then, update the following Signal Activity object type layouts: 

Update the Signal Activity Individual Case Review Layout

To update the object layout for the Signal Activity Individual Case Review object type: 

  1. Ensure the Details section includes the following fields: 
    • Description
    • Aggregate Reporting Group
    • Product Family
    • Case States to Include
    • Activity Review Due in Days
    • Schedule Start Date
  2. After the Details section, insert related object sections using the table below. 
  3. Create layout rules using the table below and select Save: 
Related Object Section Label Creation Option
Signal Activity Search Criteria > Signal Search Criteria Enter Search Criteria Select Create record in pop-up dialog
Signal Activity Case Routing Criteria Enter Case Routing Criteria Select Create record in pop-up dialog
Label If this Layout Rule Expression is True Apply the following display effects
Enter Hide when Tier is populated Enter Not(IsBlank(tier__v)) Select Hide > Fields > Product Family, Aggregate Reporting Group, Schedule Start Date, Signal Detection Plan, Signal Product Profile, Default Workbench Dashboard, Default Calculations Setting
Enter Hide when SDP is populated Enter Not(IsBlank(signal_detection_plan__v)) Select Hide > Fields > Tier

Update the Signal Activity Literature Review Layout

To update the object layout for the Signal Activity Literature Review object type: 

  1. Ensure the Details section includes the following fields: 
    • Description
    • Product Family
    • Activity Schedule
    • Activity Review Due in Days
    • Schedule Start Date
  2. After the Details section, insert the Signal Activity Search Criteria > Signal Search Criteria related object section as follows: 
    • Section Label: Enter Search Criteria
    • Creation Option: Select Create record in pop-up dialog
  3. Create the following layout rules and select Save:
Label If this Layout Rule Expression is True Apply the following display effects
Enter Hide when Tier is populated Enter Not(IsBlank(tier__v)) Select Hide > Fields > Product Family, Aggregate Reporting Group, Schedule Start Date, Signal Detection Plan, Signal Product Profile, Default Workbench Dashboard, Default Calculations Setting
Enter Hide when SDP is populated Enter Not(IsBlank(signal_detection_plan__v)) Select Hide > Fields > Tier

Update the Signal Activity Qualitative Review Layout

To update the object layout for the Signal Activity Qualitative Review object type: 

  1. Ensure the Details section includes the following fields: 
    • Description
    • Aggregate Reporting Group
    • Product Family
    • Activity Schedule
    • Activity Review Due in Days
    • Schedule Start Date
    • Default Workbench Report Set
  2. After the Details section, insert the Signal Activity Search Criteria > Signal Search Criteria related object section as follows: 
    • Section Label: Enter Search Criteria
    • Creation Option: Select Create record in pop-up dialog
  3. Create the following layout rules and select Save: 
Label If this Layout Rule Expression is True Apply the following display effects
Enter Hide when Tier is populated Enter Not(IsBlank(tier__v)) Select Hide > Fields > Product Family, Aggregate Reporting Group, Schedule Start Date, Signal Detection Plan, Signal Product Profile, Default Workbench Dashboard, Default Calculations Setting
Enter Hide when SDP is populated Enter Not(IsBlank(signal_detection_plan__v)) Select Hide > Fields > Tier

Update the Signal Activity Quality Review Layout

To update the object layout for the Signal Activity Quality Review object type: 

  1. Ensure the Details section includes the following fields: 
    • Description
    • Aggregate Reporting Group
    • Product Family
    • Activity Schedule
    • Activity Review Due in Days
    • Schedule Start Date
    • Default Workbench Report Set
  2. After the Details section, insert the Signal Activity Search Criteria > Signal Search Criteria related object section as follows: 
    • Section Label: Enter Search Criteria
    • Creation Option: Select Create record in pop-up dialog
  3. Create the following layout rules and select Save:
Label If this Layout Rule Expression is True Apply the following display effects
Enter Hide when Tier is populated Enter Not(IsBlank(tier__v)) Select Hide > Fields > Product Family, Aggregate Reporting Group, Schedule Start Date, Signal Detection Plan, Signal Product Profile, Default Workbench Dashboard, Default Calculations Setting
Enter Hide when SDP is populated Enter Not(IsBlank(signal_detection_plan__v)) Select Hide > Fields > Tier

Update the Signal Activity Quantitative Review Layout

To update the object layout for the Signal Activity Quantitative Review object type: 

  1. In the Signal Activity Quantitative Review layout, ensure the Details section includes the following fields: 
    • Description
    • Aggregate Reporting Group
    • Product Family
    • Activity Schedule
    • Activity Review Due in Days
    • Schedule Start Date
    • Default Calculations Setting
    • Default Workbench Dashboard
    • Signal Product Profile
  2. After the Details section, insert related object sections using the table below.
  3. Create layout rules using the table below and select Save:
Related Object Section Label Creation Option
Signal Activity Search Criteria > Signal Search Criteria Enter Search Criteria Select Create record in pop-up dialog
Signal Activity Data Source Enter Data Sources Select Create record in pop-up dialog
Signal Activity Product Identifiers Enter Product Identifiers Select Create record in pop-up dialog
Signal Activity Alert Rule Set Enter Alert Rule Sets Select Create record in pop-up dialog
Label If this Layout Rule Expression is True Apply the following display effects
Enter Hide when Tier is populated Enter Not(IsBlank(tier__v)) Select Hide > Fields > Product Family, Aggregate Reporting Group, Schedule Start Date, Signal Detection Plan, Signal Product Profile, Default Workbench Dashboard, Default Calculations Setting
Enter Hide when SDP is populated Enter Not(IsBlank(signal_detection_plan__v)) Select Hide > Fields > Tier

Update the Signal Activity Search Criteria Layout

To update the Signal Activity Search Criteria object layout, ensure the Details section includes the following fields: 

  • Activity
  • Search Criteria

Update the Signal Search Criteria Layout

To update the Signal Search Criteria object: 

  1. Navigate to Admin > Configuration > Objects > Signal Search Criteria > List Layout and reorder the fields as follows:
    • Name
    • Description
    • Search Strategy Summary
    • MedDRA Query
    • Watchlist
    • Data Fields
  2. Navigate to the Layouts tab and select the Signal Search Criteria object layout. 
  3. Ensure the Details section includes the following fields: 
    • Description
    • Search Strategy Summary
    • MedDRA Query
    • Watchlist
    • Data Fields

Update the Signal Activity Data Source Layout

To update the Signal Activity Data Source object: 

  1. Navigate to Admin > Configuration > Objects > Signal Activity Data Source > List Layout and reorder the fields as follows:
    • Name
    • Activity
    • Signal Detection Plan
    • Tier
    • Signal Source
    • Signal Source Data
    • Signal Source Data Dashboard
  2. Navigate to the Layouts tab and select the Signal Activity Data Source object layout. 
  3. Ensure the Details section includes the following fields: 
    • Activity
    • Signal Source
    • Signal Source Data
    • Signal Detection Plan
    • Tier
    • Signal Source Data Dashboard
  4. Create the following layout rules: 
Label If this Layout Rule Expression is True Apply the following display effects
Enter Hide when Tier is populated Enter Not(IsBlank(tier__v)) Select Hide > Fields > Signal Detection Plan
Enter Hide when SDP is populated Enter Not(IsBlank(signal_detection_plan__v)) Select Hide > Fields > Tier

Update the Signal Activity Product Identifier Layout

To update the Signal Activity Product Identifier object: 

  1. Navigate to Admin > Configuration > Objects > Signal Activity Product Identifier > List Layout and reorder the fields as follows:
    • Name
    • Activity
    • Signal Detection Plan
    • Activity Data Source
    • Product Identifier
    • Product Identifier Value
  2. Navigate to the Layouts tab and select the Signal Activity Product Identifier object layout. 
  3. Ensure the Details section includes the following fields: 
    • Activity
    • Activity Data Source
    • Product Identifier
    • Product Identifier Value
    • Signal Detection Plan

Update the Signal Activity Alert Rule Set Layout

To update the Signal Activity Alert Rule Set object: 

  1. Navigate to Admin > Configuration > Objects > Signal Activity Alert Rule > List Layout and reorder the fields as follows:
    • Name
    • Activity
    • Signal Detection Plan
    • Tier
    • Signal Alert Rule Set
  2. Navigate to the Layouts tab and select the Signal Activity Alert Rule Set object layout. 
  3. Ensure the Details section includes the following fields: 
    • Activity
    • Signal Alert Rule Set
    • Signal Detection Plan
    • Tier
  4. Create the following layout rules: 
Label If this Layout Rule Expression is True Apply the following display effects
Enter Hide when Tier is populated Enter Not(IsBlank(tier__v)) Select Hide > Fields > Signal Detection Plan
Enter Hide when SDP is populated Enter Not(IsBlank(signal_detection_plan__v)) Select Hide > Fields > Tier

Update the Signal Activity Case Routing Criteria Layout

To update the Signal Activity Case Routing Criteria object: 

  1. Navigate to Admin > Configuration > Objects > Signal Activity Case Routing Criteria > List Layout and reorder the fields as follows:
    • Name
    • Activity
    • Signal Detection Plan
    • Tier
    • Case Routing Criteria
  2. Navigate to the Layouts tab and select the Signal Activity Case Routing Criteria object layout. 
  3. Ensure the Details section includes the following fields: 
    • Activity
    • Case Routing Criteria
    • Signal Detection Plan
    • Tier
  4. Create the following layout rules: 
Label If this Layout Rule Expression is True Apply the following display effects
Enter Hide when Tier is populated Enter Not(IsBlank(tier__v)) Select Hide > Fields > Signal Detection Plan
Enter Hide when SDP is populated Enter Not(IsBlank(signal_detection_plan__v)) Select Hide > Fields > Tier

Update the Signal Product Profile Layout

To update the Signal Product Profile object layout, add the following fields to the Details section: 

  • Signal Detection Plan
  • Therapeutic Area

Optionally, you can navigate to the Fields tab and select Allow user to select multiple values for the Therapeutic Area field depending on your business needs.

Update Object Lifecycles

You can configure a Signal Detection Plan object workflow according to your business needs. Alternatively, the sections below describe how to configure the following object lifecycles for an example Signal Detection Plan process: 

Update the Signal Detection Plan Lifecycle

Using the following table, configure user actions and entry actions for the applicable Signal Detection Plan object lifecycle states: 

Lifecycle State User Action Entry Action
New
  • Condition Type: Select Always
  • Allow the following actions: Select Change State to > In Review
    • Action Label: Enter Change State to In Review
  • Condition Type: Select Always
  • Perform actions:
    • Select Update field
      • Fields: Select Plan Version (Major)
      • Set to value: Enter Floor(0)
    • Select Update field
      • Fields: Select Plan Version (Minor)
      • Set to value: Enter Floor(1)
    • Select Update field
      • Fields: Select Plan Version Effective Date
      • Set to value: Enter null
    • Select Change related object lifecycle state
      • Related Object: Select Signal Activities
      • Change State To: Select New
In Review
  • Condition Type: Select Always
  • Allow the following actions: Select Change State to > Approved
    • Action Label: Enter Change State to Approved
  • Condition Type: Select Always
  • Perform actions:
    • Select Update field
      • Fields: Select Plan Version (Minor)
      • Set to value: Enter Floor(If(IsBlank(plan_version_minor__v), 1, plan_version_minor__v + 1))
    • Select Change related object lifecycle state
      • Related Object: Select Signal Activities
      • Change State To: Select In Review
      • Select the Conditions On Related Records checkbox
      • Condition: Select Include related records in the following lifecycle states
      • Related Record's State: Select New
Approved
  • Condition Type: Select Always
  • Allow the following actions: Select Change State to > In Implementation
    • Action Label: Enter Change State to In Implementation
  • Condition Type: Select Always
  • Perform actions:
    • Select Update field
      • Fields: Select Plan Version (Major)
      • Set to value: Enter Floor(If(IsBlank(plan_version_major__v), 1, plan_version_major__v + 1))
    • Select Update field
      • Fields: Select Plan Version (Minor)
      • Set to value: Enter Floor(0)
    • Select Update field
      • Fields: Select Plan Version Effective Date
      • Set to value: Enter Now()
    • Select Change related object lifecycle state
      • Related Object: Select Signal Activities
      • Change State To: Select Approved
      • Select the Conditions On Related Records checkbox
      • Condition: Select Include related records in the following lifecycle states
      • Related Record's State: Select In Review and In Revision
In Implementation
  • Condition Type: Select Always
  • Allow the following actions: Select Change State to > In Effect
    • Action Label: Enter Change State to In Effect
  • Condition Type: Select Always
  • Perform actions:
    • Select Change related object lifecycle state
      • Related Object: Select Signal Activities
      • Change State To: Select In Implementation
      • Select the Conditions On Related Records checkbox
      • Condition: Select Include related records in the following lifecycle states
      • Related Record's State: Select Approved
In Effect
  • Condition Type: Select Always
  • Allow the following actions: Select Change State to > In Revision
    • Action Label: Enter Change State to In Revision
  • Condition Type: Select Always
  • Perform actions:
    • Select Change related object lifecycle state
      • Related Object: Select Signal Activities
      • Change State To: Select In Effect
      • Select the Conditions On Related Records checkbox
      • Condition: Select Include related records in the following lifecycle states
      • Related Record's State: Select In Effect
In Revision N/A
  • Condition Type: Select Always
  • Perform actions:
    • Select Update field
      • Fields: Select Plan Version (Minor)
      • Set to value: Enter Floor(If(IsBlank(plan_version_minor__v), 1, plan_version_minor__v + 1))
    • Select Change related object lifecycle state
      • Related Object: Select Signal Activities
      • Change State To: Select In Revision
      • Select the Conditions On Related Records checkbox
      • Condition: Select Include related records in the following lifecycle states
      • Related Record's State: Select In Effect
    • Select Change related object lifecycle state
      • Related Object: Select Signal Activities
      • Change State To: Select In Review
      • Select the Conditions On Related Records checkbox
      • Condition: Select Include related records in the following lifecycle states
      • Related Record's State: Select New

Update the Signal Search Criteria Lifecycle

Using the following table, configure state change user actions for the applicable Signal Search Criteria object lifecycle states: 

Lifecycle State User Action
New
  • Condition Type: Select Always
  • Allow the following actions: Select Change State to > In Review
    • Action Label: Enter Change State to In Review
In Review
  • Condition Type: Select Always
  • Allow the following actions: Select Change State to > Approved
    • Action Label: Enter Change State to Approved
Approved
  • Condition Type: Select Always
  • Allow the following actions: Select Change State to > In Review
    • Action Label: Enter Change State to In Review

Update Atomic Security

Update atomic security for the following object lifecycles: 

Update Signal Detection Plan Atomic Security

To control access to Signal Activities based on the Signal Detection Plan, set atomic security on relationships for the applicable states of the Signal Detection Plan object lifecycle to ensure the default behavior option for the Signal Activities object is Edit.

Update Signal Activity Atomic Security

To control access to Signal Activity child objects based on the Signal Activity, set atomic security on relationships for the applicable states of the Signal Activity object lifecycle to ensure the default behavior option for the following child objects is Edit:

  • Signal Activity Alert Rule Set
  • Signal Activity Case Routing Criteria
  • Signal Activity Data Source
  • Signal Activity Product Identifier
  • Signal Activity Search Criteria

Grant Permissions

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

The following table includes objects this feature introduces, and the recommended level of access for your permission sets: 

Permission Set Object Object Permissions
[Applicable Data Entry User Permission Set]

These users decide the signal detection methodology and plan.

 Signal Activity
  • Read
Signal Activity Alert Rule Set
  • Read
Signal Activity Case Routing Criteria
  • Read
Signal Activity Data Source
  • Read
Signal Activity Product Identifier
  • Read
Signal Activity Search Criteria
  • Read
Signal Product Tier
  • Read
  • Create
  • Edit
Signal Detection Plan
  • Read
  • Create
  • Edit
Signal Search Criteria
  • Read
  • Create
  • Edit
[Applicable Reviewer or QC Permission Set] Signal Activity
  • Read
Signal Activity Alert Rule Set
  • Read
Signal Activity Case Routing Criteria
  • Read
Signal Activity Data Source
  • Read
Signal Activity Product Identifier
  • Read
Signal Activity Search Criteria
  • Read
Signal Product Tier
  • Read
Signal Detection Plan
  • Read
Signal Search Criteria
  • Read
[Applicable Business Admin or Safety Lead Permission Set]

These users approve the signal detection methodology and plan.

 Signal Activity
  • Read
Signal Activity Alert Rule Set
  • Read
Signal Activity Case Routing Criteria
  • Read
Signal Activity Data Source
  • Read
Signal Activity Product Identifier
  • Read
Signal Activity Search Criteria
  • Read
Signal Product Tier
  • Read
  • Delete
Signal Detection Plan
  • Read
  • Delete
Signal Search Criteria
  • Read
  • Delete
[Applicable Admin Permission Set for Implementing Search Criteria] Signal Activity
  • Read
Signal Activity Alert Rule Set
  • Read
Signal Activity Case Routing Criteria
  • Read
Signal Activity Data Source
  • Read
Signal Activity Product Identifier
  • Read
Signal Activity Search Criteria
  • Read
Signal Detection Plan
  • Read
Signal Search Criteria
  • Read

Activate Document Types

For the Signal Management document type, activate the Signal Detection Plan subtype and Version Summary classification.

Optional: Configure Tabs

Optionally, you can create a custom tab to view the following objects in a single list: 

Label Tab Type Object
Enter Signal Detection Plans Select Object Select Signal Detection Plans
Enter Signal Product Tiers Select Object Select Signal Product Tiers

After configuring the tabs, you can add them to an existing tab collection.