Enable PVA Management

Learn how to configure your Vault to support the management of Pharmacovigilance Agreements.

About the Feature

With the 23R1 release, Vault 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.

See Manage Pharmacovigilance Agreements for more information.

24R3 Update: Pharmacovigilance Agreements Usability Improvements

With the 24R3 release, Vault 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.

Configure Layouts

Configure the layouts for PVA management.

Configure the Relationship Layout

Complete the following steps to configure the layout for the PVA Relationship object:

  1. Navigate to Admin > Configuration > Objects > PVA Relationship > Layouts > Relationship Detail Page Layout.
  2. Select Edit.
  3. Configure the layout as shown below:
    Relationship Detail Page Layout
  4. Select Save.

Configure the PV Agreement Layout

Complete the following steps to configure the layout for the PV Agreement object:

  1. Navigate to Admin > Configuration > Objects > PVA Agreement > Layouts > PV Agreement Detail Page Layout.
  2. Select Edit.
  3. Configure the layout as shown below:
    PV Agreement Detail Page Layout
  4. Select Save.

Configure Document Types

Configure the document type group for PVA management and associate it with the PVA document type.

Configure the PVA Documents 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

  1. Navigate to Admin > Configuration > Document Types > Pharmacovigilance Agreements.
  2. On the General tab of the Edit Details: Pharmacovigilance Agreements window, select PVA Documents for Document Type Groups.
  3. Select Save.

Configure Security

Add 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.

Add the PVA Actions Permission Set

  1. Navigate to Admin > Users & Groups > Permission Sets.
  2. Select Create.
  3. In the Name field, enter “PVA Actions.”
  4. Select Save.

Grant Permissions

Grant the appropriate level of access to applications, objects, and tabs according to your organization’s process.

  1. Navigate to Users & Groups > Permission Sets > PVA Actions.
  2. On the Application tab, select Edit.
  3. Grant Vault Actions permissions as shown in the following table:
    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
  4. Select Save.
  5. On the Objects tab, select Edit.
  6. Grant Object Permissions as shown in the following table:
    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
  7. Select Save.
  8. On the Tabs tab, select Edit.
  9. Grant View permission for the following Tabs:
    • Home
    • Library
    • PVAs
      • PVA Relationships
      • PV Agreements
      • Open PVA Actions
    • Analytics
      • Reports
      • Dashboards
  10. Select Save.

Add the PVA Management Security Profile

  1. Navigate to Admin > Users & Groups > Security Profiles.
  2. Select Create.
  3. For Name, enter “PVA Management”.
  4. Select Save.
  5. Select the newly-created PVA Management security profile.
  6. In the Permission Sets section, select Add > Existing Permission Set.
  7. In the Choose Permission Set window, select PVA Actions from the drop-down.
  8. Select OK.

Add Groups

Add the following groups to complete PVA management actions:

Add the PVA Users Group

  1. Navigate to Admin > Users & Groups > Groups.
  2. Select Create.
  3. In the Label field, enter “PVA Users”.
  4. In the Included Security Profiles field, select PVA Management.
  5. Select Save.

Add the PVA Viewers Group

  1. Navigate to Admin > Users & Groups > Groups.
  2. Select Create.
  3. In the Label field, enter “PVA Viewers”.
  4. In the Included Security Profiles field, select PVA Management.
  5. Select Save.

Add the PVA Consumers Group

  1. Navigate to Admin > Users & Groups > Groups.
  2. Select Create.
  3. In the Label field, enter “PVA Consumers”.
  4. In the Included Security Profiles field, select PVA Management.
  5. Select Save.

Configure Custom Sharing Rules for PVA Objects

Configure a Custom Sharing Rule for the following PVA objects:

  • PV Agreement
  • PVA Action Item
  • PVA Activity
  • PVA Contact
  • PVA Obligation
  • PVA Reconciliation
  • PVA Relationship

Complete the following steps:

  1. Navigate to Admin > Configuration > Objects > [Object].
  2. Select Edit.
  3. Select the Enable Custom Sharing Rules checkbox.
  4. When prompted, select Continue, and then select Save.
  5. On the Sharing Rules tab, select Create.
  6. Enter a Label.
  7. Select Save.
  8. Open the newly-created Custom Sharing Rule from the Sharing Rules tab.
  9. In the Roles section, 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

Follow the process outlined below to configure the PV Agreement object lifecycle:

Configure Settings on the PV Agreement Lifecycle

  1. Navigate to Admin > Configuration > Object Lifecycles > PV Agreement Lifecycle.
  2. In the Roles section, select Add Role.
  3. In the Search: Application Role window, select the following roles:
    • Approver
    • Reviewer
    • Safety Operations
  4. Select OK.
  5. In the Roles section, select Edit.
  6. Update the roles 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
  7. Select Save.
  8. In the States section, select Effective.
  9. In the Entry Criteria section, select Edit.
  10. Select Create Rule and configure the following rules 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
  11. Select Save.
  12. Return to Admin > Configuration > Object Lifecycles > PV Agreement Lifecycle.
  13. In the Atomic Security: Relationships section of the Effective state, select Edit.
  14. Configure the following relationships:
    Relationship Label Default
    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
  15. Select Save.
  16. Return to Admin > Configuration > Object Lifecycles > PV Agreement Lifecycle.
  17. In the States section, select Terminated.
  18. In the Atomic Security: Relationships section of the Terminated state, select Edit.
  19. Configure the following relationships:
    Relationship Label Default
    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
  20. Select Save.
  21. In the Entry Criteria section of the Terminated state, select Edit.
  22. Configure the following rule to Always validate:
    • State of Related Record
    • PVA Activities
    • No records Include
    • Received from Partner, New, In Progress
  23. Select Save.

Configure the PVA Lifecycle Stage Group

  1. Navigate to Admin > Configuration > Lifecycle Stage Groups.
  2. Select Create.
  3. In the Create Lifecycle Stage Group window, select Object Stage Group.
  4. Select Continue.
  5. On the Create Lifecycle Stage Group page, complete the following:
    1. Stage Group Label: Enter “PVA Stages”.
    2. Object Lifecycle: Select PV Agreement Lifecycle.
    3. Object Type: Select Base PV Agreement.
    4. Select Save.
  6. In the Stages section, Create the following stages:
    Stage Description
    New Initiated
    Pending Scoping, Drafting, In Approval
    Effective Effective
    Terminated Terminated

Configure the PVA Document Lifecycle

Complete the following steps to configure this lifecycle:

Add the PVA Lifecycle

  1. Navigate to Admin > Configuration > Document Lifecycles.
  2. Select Create.
  3. In the Label field, enter “PVA Lifecycle”.
  4. In the Status field, select Active.
  5. Select Save.

Configure Settings on the PVA Lifecycle

Navigate to Admin > Configuration > Document Lifecycles > PVA Lifecycle and complete the following steps.

1. Add States

On the PVA Lifecycle, in the States section, select Create and add the following states:

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

2. Add State Security Settings

On the PVA Lifecycle, in the States section, go to [State] > Security Settings and configure security settings for each of the previously created states as follows:

Draft State Security settings on the Draft state

In Review State Security settings on the In Review state

In Approval State Security settings on the In Approval state

Approved State Security settings on the Approved state

Obsolete State Security settings on the Obsolete state

Superseded State Security settings on the Superseded state

Planned State Security settings on the Planned state

3. Create Entry Actions in the Approved State

On the PVA Lifecycle, in the States section, select Approved > Entry Actions > Edit. Create the following entry actions:

Always

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

Security settings on the Approved state

4. Edit PVA Lifecycle Details

On the PVA Lifecycle, in the Details section, select Edit and 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

5. Add Default Rules to Roles

On the PVA Lifecycle, in the Roles section, select a role and go to Default Rule. Add the following rules for the Consumer, Viewer, and Editor roles.

Consumer Role Default rules on the Consumer Role

Viewer Role Default rules on the Viewer Role

Editor Role Default rules on the Editor Role

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 Lifecycle Stage Group

  1. Navigate to Admin > Configuration > Lifecycle Stage Groups.
  2. Select Create.
  3. In the Create Lifecycle Stage Group window, select Document Stage Group.
  4. Select Continue.
  5. On the Create Lifecycle Stage Group page, complete the following:
    • Stage Group Label: “PVA Document Stages”.
    • Document Lifecycle: Select PVA Lifecycle.
  6. Select Save.
  7. In the Stages section, Create the following stages:
    Stage Description
    New Draft, Planned
    Authoring In Authoring, Ready for Review
    Review & Approval In Review, Ready for Approval, In Approval
    Approved Approved

Configure Object Workflows

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

Add the PVA Creation Workflow

Complete the following steps to set up a 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, complete the following:
    • Label: Enter “PVA Creation Workflow”.
    • Lifecycle: Select PV Agreement Lifecycle.
  6. Configure the workflow as shown below:
    PVA Creation workflow
  7. In the Status field, select Make configuration active.

Add the PVA Close-Out Workflow

Complete the following steps to set up a 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. On the Create Workflow page, complete the following:
    • Label: Enter “VA Close-Out Workflow”.
    • Lifecycle: Select PV Agreement Lifecycle.
  5. Configure the workflow as shown below:
    PVA Close-Out Workflow
  6. In the Status field, select Make configuration active.

Add User Actions to the PV Agreement Lifecycle

Navigate to Admin > Configuration > Object Lifecycles > PV Agreement Lifecycle > States. Add user actions to the Initiated and Effective states as follows:

  • Initiated state:
    • Always start the PVA Creation workflow
    • Action Label: “Start PVA Authoring”
  • Effective state:
    • Always start the PVA Close-Out workflow
    • Action Label: “Close out PVA”

Add the PVA Activity Outbound Workflow

Outbound activities are completed by your organization and sent to partner organizations for review. Complete the following steps to set up a workflow to manage PVA outbound activies:

  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, complete the following:
    • Label: Enter “PVA Activity Outbound Workflow”.
    • Lifecycle: Select PV Activity Lifecycle.
  6. Configure the workflow as shown below:
    PVA Activity Outbound workflow
  7. In the Status field, select Make configuration active.

Add the PVA Activity Inbound Workflow

Inbound activities are completed by a partner organization and sent to your organization for review. Complete the following steps to set up a workflow to manage PVA inbound activies:

  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, complete the following:
    • Label: Enter “PVA Activity Inbound Workflow”.
    • Lifecycle: Select PV Activity Lifecycle.
  6. Configure the workflow as shown below:
    PVA Activity Inbound workflow
  7. In the Status field, select Make configuration active.

Add User Actions to the PVA Activity Lifecycle

Navigate to Admin > Configuration > Object Lifecycles > PVA Activity Lifecycle > States. Add the following user actions to the New state:

  • Always: Start the PVA Activity Outbound workflow
    • Action Label: “Start Outbound Activity”
  • Always: Start the PVA Activity Inbound workflow
    • Action Label: “Start Inbound Activity”

Configure Document Workflows

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

Add the 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, complete the following:
    • Label: Enter “PVA Authoring Workflow”.
    • Lifecycle: Select PV Lifecycle.
  6. Configure the workflow as shown below:
    PVA Authoring workflow
  7. In the Status field, select Make configuration active.

Add the 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, complete the following:
    • Label: Enter “PVA Review Workflow”.
    • Lifecycle: Select PV Lifecycle.
  6. Configure the workflow as shown below:
    PVA Review workflow
  7. In the Status field, select Make configuration active.

Add the 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, complete the following:
    • Label: Enter “PVA Approval Workfloww”.
    • Lifecycle: Select PVA Lifecycle.
  6. Configure the workflow as shown below:
    PVA Approval workflow
  7. In the Task: Approve step, select Edit.
  8. In the Prompts section, configure the following settings:
    • Select the Prompt for Verdicts checkbox.
    • Select the Multiple Verdicts: One verdict for each item option.
  9. 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.
  10. On the PVA Approval workflow page, in the Status field, select Make configuration active.

Add User Actions to the PVA Lifecycle

Navigate to Admin > Configuration > Document Lifecycles > PVA Lifecycle > States. Add user actions to the Draft, Ready for Review, and Ready for Approval states according to the following table:

State User Action
Draft
  • Always: Start the PVA Authoring workflow
  • Action Label: "Start Authoring"
Draft
  • Always: Start the PVA Review workflow
  • Action Label: "Start Review"
Ready for Review
  • Always: Start the PVA Review workflow
  • Action Label: "Start Review"
Ready for Approval
  • Always: Start the PVA Approval workflow
  • Action Label: "Start Approval"

Manage Tabs

For easy user access to PVA management features, configure the following tab settings in your Vault.

Activate PVA Tabs

Activate the following tabs:

  • PVA Relationships
  • PV Agreements
  • Open PVA Action

To activate a tab:

  1. Navigate to Admin > Configuration > Tabs > [Tab].
  2. Select Edit.
  3. In the Status field, select Active.
  4. Select Save.

Create a PVA Tab Collection

  1. Navigate to Admin > Configuration > Tab Collections.
  2. Select Create.
  3. In the Label field, enter “PVAs”.
  4. In the Status field, select Active.
  5. Select Add Tabs.
  6. In the Select Tabs and Menus window, add the following tabs:
    • Home
    • PVAs
    • Library
    • Analytics
  7. Select Save.

(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 (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