Enable PVA Management

With the 23R1 release, SafetyDocs supports the management of Pharmacovigilance Agreements (PVAs), sometimes known as Safety Data Exchange Agreements (SDEAs). This feature promotes regulatory compliance through centralized document storage, making it easy to review and reconcile partner obligations across agreements. In addition, contact management capabilities increase the efficiency of tracking reconciliation activities and managing follow-up agreements.

Updates

We have added the following updates to this feature:

• PVA: Defer Contact Entry: With the 26R1 release, SafetyDocs allows you to configure the Partner Contact and Sponsor Contact fields on the PVA Obligation object as optional on initial record creation, enabling users to create PVA Obligations when sponsor or partner contact information is not yet known. See Configure PVA: Defer Contact Entry to configure your Vault for this feature.
• Product Family Support for PV Agreements: With the 25R3 release, SafetyDocs introduces the ability to classify PV Agreements at the Product Family level, enabling more efficient agreement management and improving scalability across product portfolios. See Configure Product Family Support for PV Agreements to configure your Vault for this feature.
• PVA Scheduling: With the 25R1 release, SafetyDocs supports PVA Scheduling. Scheduling defines when and how often Vault creates PVA Activity records and documents for a given PVA Obligation record. This is useful in situations where a PVA has obligations with recurring activities, such as circulating a weekly summary of literature articles. For more information, see Enable PVA Scheduling.
• Pharmacovigilance Agreements Usability Improvements: With the 24R3 release, SafetyDocs displays more meaningful values when a PVA object is referenced in an object field rather than the auto-generated name for improved usability of PVA-related records. See Configure Pharmacovigilance Agreements Usability Improvements for details. In addition to the configuration updates described on this page, you must configure the PVA Activity Outbound Workflow as described in Enable PVA Document Distribution via Vault Task.

Overview

To configure this feature:

• Configure object layouts
• Configure document types
• Configure security
• Configure custom sharing rules
• Configure the PV Agreement Lifecycle object lifecycle
• Configure the PVA Lifecycle document lifecycle
• Configure object workflows
• Configure document workflows
• Configure tabs

Configure Object Layouts

Configure the following object layouts:

• PVA Relationship
• PV Agreement

Configure the PVA Relationship Object Layout

To configure the PVA Relationship object layout:

1. Navigate to Admin > Configuration > Objects > PVA Relationship > Layouts > Relationship Detail Page Layout.
2. Select Edit.
3. Configure the layout as follows:
   • Ensure the Details section contains the following fields in the following order:
     • Name
     • Partner
     • Description
   • Ensure the PV Agreements section contains the following default columns in the following order:
     • Name
     • Agreement Title
     • PVA Scope
     • Agreement Effective Date
     • Agreement End Date
     • Agreement Owner
   • Ensure there is a Workflow Timeline section
4. Select Save.

Configure the PV Agreement Object Layout

To configure the PV Agreement object layout:

1. Navigate to Admin > Configuration > Objects > PV Agreement > Layouts > PV Agreement Detail Page Layout.
2. Select Edit.
3. Configure the layout as follows:
   • Ensure the Details section contains the following fields in the following order:
     • Relationship
     • Agreement Title
     • Agreement Effective Date
     • Agreement End Date
     • PVA Scope
     • Agreement Owner
     • Agreement Notes
   • Ensure the following related object sections appear in the following order, with the specified default columns:
     • Covered Products
       • Product Name
       • Product Type
       • Abbreviation
     • Covered Studies
       • Study Number
       • Study Name
       • Protocol Title
       • Study Type
       • Masking
     • Agreement Countries
       • Name
       • Code (2-letter)
       • Code (3-letter)
       • Agency
     • Contacts
       • Name
       • Person
       • Vault User
       • Contract Party
       • Communication Method
     • Action Items
       • Name
       • Assigned To
       • Agreement Contact
       • Due Date
       • Completion Date
       • Description
     • Obligations
       • Name
       • Obligation Category
       • Clause Title
       • Partner Contact
       • Sponsor Contact
     • Activities
       • Name
       • Obligation Title
       • Due Date
       • Completion Date
       • Partner Responsible Contact
       • Sponsor Responsible Contact
     • Reconciliations
       • Name
       • Assigned To
       • Obligation Name
       • Activity
       • Due Date
       • Evaluation
     • Agreement Documents
       • Name
       • Title
       • Status
   • Ensure there is a Workflow Timeline section
   • Ensure there is a Signatures section with the following columns:
     • Name
     • Signature Name
     • Signature Meaning
     • Signature Status
4. Select Save.

Configure Document Types

To configure document types:

• Create a Document Type Group
• Add the Document Type Group to the Pharmacovigilance Agreements document type

Create the PVA Documents Document Type Group

To create a Document Type Group:

1. Navigate to Business Admin > Objects > Document Type Groups.
2. Select Create.
3. In the Name field, enter PVA Documents.
4. Select Save.

Add the PVA Document Type Group to the PVA Document Type

To add your new Document Type Group, edit the Pharmacovigilance Agreements document type. In the General tab, select PVA Documents in the Document Type Groups field.

Configure Security

Configure security settings to grant access to the PVA management features. Use the following settings as a starting point, but configure access according to your business process:

• Create a permission set with the label PVA Actions
• Create a security profile with the label PVA Management and assign to it the PVA Actions permission set
• Create PVA Groups
• Grant permissions on the PVA Actions permission set

Create PVA Groups

Create groups with the following labels, then add the PVA Management security profile to the Included Security Profiles field for each new group:

• PVA Users
• PVA Viewers
• PVA Consumers

Grant Permissions

To grant permissions to the PVA Actions permission set:

1. Grant Vault Actions application permissions as follows:

   Vault Action	Permissions
   Dashboards and Reports	Create Dashboards Delete Dashboards Share Dashboards Schedule Reports Read Group Membership
   Workflows	Start Read and Understand eSignature
   CrossLink	Create CrossLink
   Viewer Administration	Manage Tags
   Document	Cancel Checkout Download Document Download Rendition
   User	Allow As A Delegate View User Information View User Profile
   Search	User Filters
   Views	Share Views
   Audit Trail	View

2. Grant object permissions as follows:

   Objects	Permissions
   Application Role Country Document Stages Document Type Group Language Language (ISO) Object Stages Person Product Product Alias Product Constituent Product Family Product Registration Product Substance Study Study Registration Study Product Study Site Substance Substance Alias	Read
   Organization PV Agreement PVA Action Item PVA Activity PVA Contact PVA Obligation PVA Reconciliation PVA-Country PVA-Product PVA-Study PVA Relationship	Create
   Organization PV Agreement PVA Action Item PVA Activity PVA Contact PVA Obligation PVA Reconciliation PVA-Country PVA-Product PVA-Study PVA Relationship	Edit
   PV Agreement PVA Action Item PVA Activity PVA Contact PVA Obligation PVA Reconciliation PVA-Country PVA-Product PVA-Study PVA Relationship	Delete

3. Grant View tab permissions for the following Tabs:
   • Home
   • Library
   • PVAs
     • PVA Relationships
     • PV Agreements
     • Open PVA Actions
   • Analytics
     • Reports
     • Dashboards

Configure Custom Sharing Rules for PVA Objects

To configure custom sharing rules:

1. Enable custom sharing rules for the following objects:
   • PV Agreement
   • PVA Action Item
   • PVA Activity
   • PVA Contact
   • PVA Obligation
   • PVA Reconciliation
   • PVA Relationship
2. For each object, create a custom sharing rule and add manual assignments as follows:

   Role	Users & Groups
   Viewer	PVA Consumers
   Owner	PVA Users
   Editor	PVA Users
   Viewer	PVA Viewers

Configure the PV Agreement Object Lifecycle

To configure the PV Agreement Lifecycle object lifecycle:

• Add roles
• Edit role permissions
• Configure atomic security on relationships
• Create entry criteria
• Configure a lifecycle stage group

Add Lifecycle Roles

Add the following roles to the PV Agreement Lifecycle:

• Approver
• Reviewer
• Safety Operations

Edit Role Permissions

Edit role permissions on the specified states of the PV Agreement Lifecycle as follows:

Role	Permissions
Approver	All states: Read
Editor	Drafting: Edit Scoping: Edit Initiated: Delete
Owner	Drafting: Edit Scoping: Edit Initiated: Delete
Reviewer	All states: Read
Safety Operations	All states: Read

Configure Atomic Security on Relationships

Configure atomic security on relationships on the Effective and Terminated states of the PV Agreement Lifecycle as follows:

Lifecycle State	Relationship Label	Default
Effective	PVA Action Items	Edit
	PVA Activities	Edit
	PVA Contacts	Read
	PVA Obligations	Read
	PVA Reconciliations	Edit
	PVA-Countries	Read
	PVA-Products	Read
	PVA-Studies	Read
Terminated	PVA Action Items	Read
	PVA Activities	Read
	PVA Contacts	Read
	PVA Obligations	Read
	PVA Reconciliations	Edit
	PVA-Countries	Read
	PVA-Products	Read
	PVA-Studies	Read

Create Entry Criteria

Create entry criteria on the following states of the PV Agreement Lifecycle:

• On the Terminated state, create an entry criteria to Always validate:
  • State of Related Record
  • PVA Activities
  • No records Include
  • Received from Partner, New, In Progress
• On the Effective state, create an entry criteria to Always validate:
  • Field > Agreement Effective Date > is not blank
  • Field > Agreement End Date > is not blank
  • Field > Agreement Owner > is not blank
  • Field > PVA Scope > is not blank

Configure the PVA Lifecycle Stage Group

Create an object lifecycle stage group with the following settings:

• Stage Group Label: Enter PVA Stages
• Object Lifecycle: Select PV Agreement Lifecycle
• Object Type: Select Base PV Agreement

Then, create stages and define their states as follows:

• Create the New stage, then add the Initiated state
• Create the Pending stage, then add the following states:
  • Scoping
  • Drafting
  • In Approval
• Create the Effective stage, then add the Effective state
• Create the Terminated stage, then add the Terminated state

Configure the PVA Lifecycle Document Lifecycle

To configure the PVA Lifecycle document lifecycle:

• Create a document lifecycle with the label PVA Lifecycle
• Create lifecycle states
• Update lifecycle state security settings
• Create entry actions on the Approved state
• Define state types
• Define allowed and default users on roles
• Add the PVA Lifecycle to the Pharmacovigilance Agreements document type
• Configure a lifecycle stage group

Create Lifecycle States

Create the following lifecycle states on the PVA Lifecycle:

• Draft
• In Review
• In Approval
• In Authoring
• Approved
• Obsolete
• Superseded
• Ready for Review
• Ready for Approval
• Planned

Update Lifecycle State Security Settings

Update document lifecycle state security settings for the following states on the PVA Lifecycle:

• Draft
• In Review
• In Approval
• Approved
• Obsolete
• Superseded
• Planned

Update Draft State Security Settings

Update lifecycle state security settings on the Draft state of the PVA Lifecycle as follows:

Role	Security Settings
Owner	View Document View Content Edit Fields Edit Relationships Edit Sharing Settings Annotate Download Source Edit Document Manage Viewable Rendition Reclassify Change Owner Change Coordinator Delete
Coordinator	View Document View Content Edit Fields Edit Relationships Edit Sharing Settings Annotate Download Source Edit Document Change Owner Change Coordinator
Editor	View Document View Content Edit Fields Edit Relationships Edit Sharing Settings Annotate Download Source Edit Document
Viewer	View Document View Content
Consumer	No permissions
Reviewer	View Document View Content Edit Fields Annotate Download Source Edit Document
Approver	View Document View Content Edit Fields Annotate Download Source Edit Document

Update In Review State Security Settings

Update lifecycle state security settings on the In Review state of the PVA Lifecycle as follows:

Role	Security Settings
Owner	View Document View Content Edit Fields Edit Relationships Edit Sharing Settings Annotate Change Owner Change Coordinator
Coordinator	View Document View Content Edit Fields Edit Relationships Edit Sharing Settings Annotate Change Owner Change Coordinator
Editor	View Document View Content Edit Fields Edit Relationships Edit Sharing Settings Annotate
Viewer	View Document View Content
Consumer	No permissions
Reviewer	View Document View Content Annotate
Approver	View Document View Content Annotate

Update In Approval State Security Settings

Update lifecycle state security settings on the In Approval state of the PVA Lifecycle as follows:

Role	Security Settings
Owner	View Document View Content Edit Sharing Settings Download Source Change Owner Change Coordinator
Coordinator	View Document View Content Edit Sharing Settings Download Source Change Owner Change Coordinator
Editor	View Document View Content
Viewer	View Document View Content
Consumer	No permissions
Reviewer	View Document View Content Download Source
Approver	View Document View Content Download Source

Update Approved State Security Settings

Update lifecycle state security settings on the Approved state of the PVA Lifecycle as follows:

Role	Security Settings
Owner	View Document View Content Edit Sharing Settings Version Download Source Change Owner Change Coordinator
Coordinator	View Document View Content Edit Sharing Settings Version Download Source Change Owner Change Coordinator
Editor	View Document View Content Edit Sharing Settings Version Download Source
Viewer	View Document View Content Download Source
Consumer	View Document View Content Download Source
Reviewer	View Document View Content Download Source
Approver	View Document View Content Download Source

Update Obsolete State Security Settings

Update lifecycle state security settings on the Obsolete state of the PVA Lifecycle as follows:

Role	Security Settings
Owner	View Document View Content Edit Sharing Settings Download Source Change Owner Change Coordinator
Coordinator	View Document View Content Edit Sharing Settings Download Source Change Owner Change Coordinator
Editor	View Document View Content
Viewer	No permissions
Consumer	No permissions
Reviewer	No permissions
Approver	No permissions

Update Superseded State Security Settings

Update lifecycle state security settings on the Superseded state of the PVA Lifecycle as follows:

Role	Security Settings
Owner	View Document View Content Edit Sharing Settings Download Source Change Owner Change Coordinator
Coordinator	View Document View Content Edit Sharing Settings Download Source Change Owner Change Coordinator
Editor	View Document View Content Download Source
Viewer	View Document View Content
Consumer	No permissions
Reviewer	View Document View Content
Approver	View Document View Content

Update Planned State Security Settings

Update lifecycle state security settings on the Planned state of the PVA Lifecycle as follows:

Role	Security Settings
Owner	View Document View Content Edit Fields Edit Relationships Edit Sharing Settings Download Source Edit Document Change Owner Change Coordinator
Coordinator	View Document View Content Edit Fields Edit Relationships Edit Sharing Settings Download Source Edit Document Change Owner Change Coordinator
Editor	View Document View Content Edit Fields Edit Relationships Edit Sharing Settings Download Source Edit Document
Viewer	No permissions
Consumer	No permissions
Reviewer	View Document View Content Edit Fields
Approver	View Document View Content Edit Fields

Create Entry Actions on the Approved State

Create entry actions on the Approved state of the PVA Lifecycle to Always perform the following actions:

• Set new major version
• Set previous steady state to superseded

Define Lifecycle State Types

To define state types on the PVA Lifecycle, map the previously created states to state types as follows:

State Type	State
Starting State	Draft
Steady State	Approved
Superseded State	Superseded
Obsolete State	Obsolete
Document Workflow: Pre-Approval	Ready for Approval
Document Workflow: Approved	Approved
Document Workflow: Rejected	Draft
In Review	In Review
Rejected	Draft

Define Allowed and Default Users for PVA Lifecycle Roles

Define allowed and default users for the specified roles on the PVA Lifecycle as follows:

Role	Allowed User/Group	Default User
Consumer	All Users and Groups PVA Consumers	PVA Consumers
Viewer	All Users and Groups PVA Viewers	PVA Viewers
Editor	All Users and Groups PVA Users	PVA Users

Add the PVA Lifecycle to the Pharmacovigilance Agreements Document Type

To add the PVA Lifecycle to the Pharmacovigilance Agreements Document Type:

1. Navigate to Admin > Configuration > Document Types > Pharmacovigilance Agreements.
2. In the Actions menu, select Edit Details.
3. On the General tab, in the Available Lifecycles field, select PVA Lifecycle.
4. Select Save.

Configure the PVA Document Stages Lifecycle Stage Group

Create an document lifecycle stage group with the following settings:

• Stage Group Label: Enter PVA Document Stages
• Document Lifecycle: Select PVA Lifecycle

Then, create stages and define their states as follows:

• Create the New stage, then add the following states:
  • Draft
  • Planned
• Create the Authoring stage, then add the following states:
  • In Authoring
  • Ready for Review
• Create the Review & Approval stage, then add the following states:
  • In Review
  • Ready for Approval
  • In Approval
• Create the Approved stage, then add the Approved state

Configure Object Workflows

Configure the following PVA management object workflows. Use these steps as a starting point, but configure your workflows according to your business processes:

• Create the PVA Creation Workflow
• Create the PVA Close-Out Workflow
• Create the PVA Activity Outbound Workflow
• Create the PVA Activity Inbound Workflow
• Configure user actions on the PV Agreement Lifecycle and the PVA Activity Lifecycle

Create the PVA Creation Workflow

Create the following workflow to manage PVA creation:

1. Navigate to Admin > Configuration > Workflows.
2. Select Create.
3. In the Create Workflow window, select Object Workflow.
4. Select Continue.
5. On the Create Workflow page, populate the fields as follows:
   • Label: Enter PVA Creation Workflow
   • Lifecycle: Select PV Agreement Lifecycle
6. Select Save.
7. In the Workflow Steps section, configure the workflow to include the following steps:
   • Start Start step
   • SC: Scoping state change action step
   • Task: Search for Articles task step
   • Update Sharing update sharing settings step
   • Update Sharing: Approver update sharing settings step
   • Task: Scope PVA task step
   • SC: Drafting state change action step
   • Task: Draft task step
   • SC: In Approval state change action step
   • Task: Approve & Effective task step
   • SC: Effective state change action step
   • End end step
8. In the Status field, select Make configuration active.

Create the PVA Close-Out Workflow

Create the following workflow to manage PVA close-out or termination:

1. Navigate to Admin > Configuration > Workflows.
2. Select Create.
3. In the Create Workflow window, select Object Workflow.
4. Select Continue.
5. On the Create Workflow page, populate the fields as follows:
   • Label: Enter PVA Close-Out Workflow
   • Lifecycle: Select PV Agreement Lifecycle
6. Select Save.
7. In the Workflow Steps section, configure the workflow to include the following steps:
   • Start Start step
   • Task: Closeout task step
   • SC: Terminated state change action step
   • End end step
8. In the Status field, select Make configuration active.

Create the PVA Activity Outbound Workflow

Create a workflow to manage PVA outbound activities (activities completed by your organization and sent to partner organizations for review):

1. Navigate to Admin > Configuration > Workflows.
2. Select Create.
3. In the Create Workflow window, select Object Workflow.
4. Select Continue.
5. On the Create Workflow page, populate the fields as follows:
   • Label: Enter PVA Activity Outbound Workflow
   • Lifecycle: Select PVA Activity Lifecycle
6. Select Save.
7. In the Workflow Steps section, configure the workflow to include the following steps:
   • Start Start step
   • SC: In Progress state change action step
   • Update Sharing Settings update sharing settings step
   • Task: Prepare Activity task step
   • SC: Sent state change action step
   • Task: Confirm Receipt task step
   • Decision: Complete? decision step
   • SC: Complete state change action step
   • SC: Cancelled state change action step
   • End end step
8. In the Status field, select Make configuration active.

Create the PVA Activity Inbound Workflow

Create a workflow to manage PVA inbound activities (activities completed by a partner organization and sent to your organization for review):

1. Navigate to Admin > Configuration > Workflows.
2. Select Create.
3. In the Create Workflow window, select Object Workflow.
4. Select Continue.
5. On the Create Workflow page, populate the fields as follows:
   • Label: Enter PVA Activity Inbound Workflow
   • Lifecycle: Select PVA Activity Lifecycle
6. Select Save.
7. In the Workflow Steps section, configure the workflow to include the following steps:
   • Start Start step
   • SC: Received state change action step
   • Update Sharing update sharing settings step
   • Task: Verify Received Documents task step
   • SC: Complete state change action step
   • End end step
8. In the Status field, select Make configuration active.

Configure User Actions

Add user actions to the following states of the specified lifecycles:

• To the PV Agreement Lifecycle:
  • Initiated state:
    • Always: Start the PVA Creation Workflow
      • Action Label: Enter Start PVA Authoring
  • Effective state:
    • Always: Start the PVA Close-Out Workflow
      • Action Label: Enter Close out PVA
• To the New state of the PVA Activity Lifecycle:
  • Always: Start the PVA Activity Outbound Workflow
    • Action Label: Enter Start Outbound Activity
  • Always: Start the PVA Activity Inbound Workflow
    • Action Label: Enter Start Inbound Activity

Configure Document Workflows

Configure the following PVA management document workflows. Use these steps as a starting point, but configure your workflows according to your business processes:

• Create the PVA Authoring Workflow
• Create the PVA Review Workflow
• Create the PVA Approval Workflow
• Configure user actions on the PVA Lifecycle document lifecycle

Create the PVA Authoring Workflow

To create a PVA authoring workflow:

1. Navigate to Admin > Configuration > Workflows.
2. Select Create.
3. In the Create Workflow window, select Document Workflow.
4. Select Continue.
5. On the Create Workflow page, populate the fields as follows:
   • Label: Enter PVA Authoring Workflow
   • Lifecycle: Select PVA Lifecycle
6. Select Save.
7. In the Workflow Steps section, configure the workflow to include the following steps:
   • Start start step
   • SC: In Authoring state change action step
   • Task: Author task step
   • SC: Ready for Review or Draft state change action step
   • End end step
8. In the Status field, select Make configuration active.

Create the PVA Review Workflow

To create a PVA review workflow:

1. Navigate to Admin > Configuration > Workflows.
2. Select Create.
3. In the Create Workflow window, select Document Workflow.
4. Select Continue.
5. On the Create Workflow page, populate the fields as follows:
   • Label: Enter PVA Review Workflow
   • Lifecycle: Select PVA Lifecycle
6. Select Save.
7. In the Workflow Steps section, configure the workflow to include the following steps:
   • Start start step
   • SC: In Review state change action step
   • Task: Review task step
   • SC: Ready for Approval or Draft state change action step
   • End end step
8. In the Status field, select Make configuration active.

Create the PVA Approval Workflow

To create a PVA approval workflow:

1. Navigate to Admin > Configuration > Workflows.
2. Select Create.
3. In the Create Workflow window, select Document Workflow.
4. Select Continue.
5. On the Create Workflow page, populate the fields as follows:
   • Label: Enter PVA Approval Workflow
   • Lifecycle: Select PVA Lifecycle
6. Select Save.
7. In the Workflow Steps section, configure the workflow to include the following steps:
   • Start start step
   • SC: In Approval state change action step
   • Task: Approve task step, configured to include the following settings:
     • In the Prompts section:
       • Select the Prompt for Verdicts checkbox
       • Select the Multiple Verdicts: One verdict for each item option
     • In the Verdicts section, create the following verdicts:
       • Approved:
         • Select Add eSignature
         • For Instructions, enter Please provide an eSignature for Document Approval
         • Select the Manifest eSignature on document checkbox
       • Reviewed, Back to Draft:
         • Select Add Comments
         • For Prompt for comments, enter Comments
         • Select the Required checkbox
   • SC: Approved or Draft state change action step
   • End end step
8. On the PVA Approval Workflow page, in the Status field, select Make configuration active.

Create User Actions on the PVA Lifecycle

Create user actions on the following states of the PVA Lifecycle document lifecycle:

• On the Draft state:
  • Always: Start the PVA Authoring Workflow
    • Action Label: Enter Start Authoring
  • Always: Start the PVA Review Workflow
    • Action Label: Enter Start Review
• On the Ready for Review state:
  • Always: Start the PVA Review Workflow
    • Action Label: Enter Start Review
• On the Ready for Approval state:
  • Always: Start the PVA Approval Workflow
    • Action Label: Enter Start Approval

Manage Tabs

For easy user access to PVA management features:

• Set the tab status to Active for the following tabs:
  • PVA Relationships
  • PV Agreements
  • Open PVA Action
• Create an active PVAs tab collection and add the following tabs:
  • Home
  • PVAs
  • Library
  • Analytics

(26R1) Configure PVA: Defer Contact Entry

To configure the Partner Contact and Sponsor Contact fields on the PVA Obligation object as optional during initial PVA Obligation creation:

1. Navigate to Admin > Configuration > Objects > PVA Obligation > Fields.
2. Select the relevant field.
3. Select Edit.
4. Under the Options section, clear the User must always enter a value (required) attribute.
5. Select Save.

(25R3) Configure Product Family Support for PV Agreements

To allow users to classify PV Agreements at the Product Family level, you can copy the standard PV Agreement Detail Page object layout, set the copied layout as the default, and delete any other existing custom PV Agreement layouts. Alternatively, you can update the applicable PV Agreement object layouts to:

• Remove the Covered Products section
• Insert the Covered Product Families related object section below the Details section:
  • Related Object: Select PVA-Product Family > Product Family
  • Section Label: Enter Covered Product Families
  • Creation Options: Select Create record in pop-up dialog
  • Edit the default columns to display the following fields:
    • Name
    • Generic Name
    • Therapeutic Area

(24R3) Configure Pharmacovigilance Agreements Usability Improvements

To display meaningful values for PVA-related object references in records, you must update your custom object layouts to include the applicable control fields. Alternatively, you can copy the standard layouts and replace the custom layout versions in your Vault.

Update Object Layout Fields

Update the following object layouts by replacing the listed fields with the control field versions with the Slider () icon in each object layout’s Details section:

Object	Field to Remove	Control Field to Add
PVA Action Item	Agreement Contact	Agreement Contact
	PV Agreement	PV Agreement
	Related PVA Activity	Related Activity
	Related PVA Obligation	PVA Obligation
PVA Activity	Partner Responsible Contact	Partner Responsible Contact
	PV Agreement	PV Agreement
	PVA Obligation	Related Obligation
	Sponsor Responsible User	Sponsor Responsible User
PVA Contact	PV Agreement	PV Agreement
PVA Document Distribution Event	PVA Activity	Activity
	Recipient	Recipient
PVA Document for Distribution	PVA Activity	Activity
PVA Obligation	Partner Contact	Partner Contact
	Sponsor Contact	Sponsor Contact
PVA Reconciliation	Activity	Activity
	Obligation	Obligation

Edit Object Layout Default Columns

Edit the default columns for the following object layout sections to include the applicable control fields and make any additional changes for your business processes as needed:

Object	Section	Fields to Add
PV Agreement	Contacts	PV Agreement
	Action Items	Agreement Contact PV Agreement PVA Obligation Related Activity
	Obligations ICSR Reporting Obligations	Partner Contact PV Agreement Sponsor Contact
	Case Processing Activities ICSR Reporting Activities	Partner Responsible Contact PV Agreement Related Obligation Sponsor Responsible User
	PVA Reconciliations	Activity Obligation
PVA Action Item	Document Distribution Events	Activity Recipient
	Documents for Distribution	Activity
PVA Activity	Related Action Items	Agreement Contact PV Agreement Related Activity PVA Obligation
	Document Distribution Events	Activity Recipient
	Documents for Distribution	Activity
PVA Obligation	Outbound Activities Inbound Activities	Partner Responsible Contact PV Agreement Related Obligation Sponsor Responsible User
	Action Items	Agreement Contact PV Agreement PVA Obligation Related Activity
	Reconciliations	Activity Obligation