Sections in This Article
About the Feature
Vault SafetyDocs supports the centralized management of Pharmacovigilance Agreements (PVAs), sometimes known as Safety Data Exchange Agreements (SDEAs). These agreements define the obligations and actions agreed upon between two (2) or more organizations that share Safety data such as Individual Case Safety Reports (ICSRs), periodic reporting, literature monitoring, and signal detection.
The following are some situations where PVAs may be required:
- When non-sponsor organizations receive Safety data on behalf of sponsor organizations.
- When partner organizations are co-licensed to manufacture or market products.
- When partner organizations are Marketing Authorization Holders (MAHs) in different markets.
Using the PVA management features available in Vault SafetyDocs makes it easy to author, review, and manage data-sharing obligations and activities across agreements between partner organizations and maintain regulatory compliance. In addition, the system’s contact management capabilities increase the efficiency of tracking reconciliation activities and managing follow-up agreements.
Critical agreement details that can be tracked include the following:
- Effective and expiry dates
- Covered products, studies, and countries
- Agreement contacts
- Obligations
- Relevant activities under each obligation
- Reconciliations
Admins can also configure additional parameters for tracking.
The PVA Management process includes the following steps:
- Create a PVA Relationship.
- Create a PV Agreement.
- Complete a PVA Creation workflow.
- Complete a PVA Authoring workflow.
- Complete a PVA Review workflow.
- Complete a PVA Approval workflow.
- Upload PVA documents into your Vault. This step can be completed whenever you acquire related documents throughout the process.
- Update the PV Agreement with information such as covered products, studies, countries, contacts, action items, obligations, and activities.
- For each activity, complete an Inbound or Outbound PVA Activity workflow.
- As activities are completed, update the PV Agreement with appropriate reconciliations.
- When the PV Agreement ends, complete the PVA Close-out workflow.
Go through the information on this page to learn how to manage your PVAs.
Prerequisites
Your admin must configure all the steps for this feature before it can be used. See Enable PVA Management for more information.
Working with PVA Documents
When uploading PVAs, use the Pharmacovigilance Agreements document type. This includes the following subtypes and classifications:
- Pharmacovigilance Agreements > Master Agreement
- Pharmacovigilance Agreements > Agreement Documentation > PVA Core
- Pharmacovigilance Agreements > Agreement Documentation > PVA Module
- Pharmacovigilance Agreements > Agreement Documentation > PVA Appendix
- Pharmacovigilance Agreements > Agreement Documentation > PVA Summary
- Pharmacovigilance Agreements > Agreement Activities > PVA Distribution
- Pharmacovigilance Agreements > Agreement Activities > PVA Correspondence
- Pharmacovigilance Agreements > Agreement Reconciliation
Upload PVA documents using the same process as for other document types. For more information, see Upload a Document to the Library.
Create a PVA Relationship
A PVA Relationship is a compilation of all PVAs made with a specific partner organization across the duration of the partnership.
You can create a record for each partner organization and link it to the PVAs made with them. This helps you keep track of all data exchange obligations that have been agreed upon, as well as their related activities and reconciliations.
Such records are useful for maintaining compliance and managing current and future collaboration.
Complete the following steps to create a PVA Relationship:
- Go to PVAs > PVA Relationships.
- Select Create.
- Complete the fields on the Create PVA Relationship page.
- Select Save.
| Field | Description |
|---|---|
| Name | Enter a name for the PVA Relationship. |
| Description | Enter a description for the PVA Relationship. This field supports up to 1,500 characters. |
| Partner | Select a partner from the picklist. |
Create a PV Agreement
For each agreement you make with a partner organization, you can create a PV Agreement in Vault to track important details such as the period over which the agreement will last, the agreement’s scope, and the person who is responsible for managing the agreement.
Each PV Agreement is linked to a PVA Relationship within Vault SafetyDocs to keep track of all the agreements made with partner organizations.
Within each PV Agreement, you can also complete the following actions:
- List the products, studies, and countries covered by the PVA
- Store contact information of involved parties
- Record the obligations or contract terms of the PVA and track relevant activities and action items
- Record whether these obligations were met and activities were completed
- Link related documents
Complete the following steps to create a PV Agreement:
- Go to PVAs > PV Agreements.
- Select Create.
- Complete the fields on the Create PV Agreement page.
- Select Save.
| Field | Description |
|---|---|
| Agreement Title | Enter the title of the agreement. This field supports up to 1,500 characters. |
| Relationship | Select the relevant PVA relationship from the dropdown list or select Create to add a new one. |
| Agreement Effective Date | Enter the start date for the agreement. Use the calendar to select the date or enter the date manually. |
| Agreement End Date | Enter the end date for the agreement. Use the calendar to select the date or enter the date manually. |
| Agreement Notes | Enter relevant details about the agreement. This field supports up to 5,000 characters. |
| PVA Scope | Select Global or Local from the picklist, depending on the scope of the agreement. |
| Agreement Owner | Select the user who is responsible for the agreement. |
For each PVA, complete a PVA Creation workflow to track all the steps involved in authoring, reviewing, and approving the agreement.
Result
Once you save the PV agreement, the following sections appear.
Covered Products Section
Complete the following steps to add the Products covered in the PVA:
- In the Covered Products section, select Add. The Search: Product window appears.
- Use the search bar and filters to select one or more Products from the list.
- Select OK.
If you do not see your desired Products in the list, contact your Admin to add new Products to your Vault.
Covered Studies Section
Complete the following steps to add the Studies covered in the PVA:
- In the Covered Studies section, select Add. The Search: Study window appears.
- Use the search bar and filters to select one or more Studies from the list.
- Select OK.
If you do not see your desired Studies in the list, contact your Admin to add new Studies to your Vault.
Agreement Countries Section
Complete the following steps to add the Countries involved in the PVA:
- In the Agreement Countries section, select Add. The Search: Countries window appears.
- Use the search bar and filters to select one or more Countries from the list.
- Select OK.
Contacts Section
In the Contacts section, create a record for each contact person involved in the PVA. This helps discuss reconciliation terms and manage future collaboration.
Select Create and complete the following fields.
| Field | Description |
|---|---|
| Vault User | The Vault User profile of the contact. Select a User from the picklist or select the binoculars icon to use filters and refine your search. |
| Person | The person behind the User selected in the Vault User field. Select a Person from the picklist or select the binoculars icon to use filters and refine your search. |
| Contract Party | Select whether the contact is related to the Sponsor or Partner from the picklist. |
| Communication Method | Select the preferred communication method for this contact from the picklist. The available options include the following:
|
Action Items Section
In the Action Items section, create a record for each action item.
Action items are the tasks that need to be undertaken in order to create and fulfill a PVA, such as authorship, monitoring, or general management of its activities. Action items can be defined as needed and are not necessarily linked to an obligation or activity within the agreement.
Recording the details, status, and person responsible for each action item is useful for tracking and compliance purposes.
Select Create and complete the following fields to create an Action Item:
| Field | Description |
|---|---|
| Name | The system automatically populates this field based on the details from the record. |
| Description | Enter a description for the action item. This field supports up to 1,500 characters. |
| Assigned To | The individual to whom the action item is assigned. Select a User from the picklist. |
| Due Date | Enter the date on which the action item is due for completion. Use the calendar to select the date or enter the date manually. |
| Completion Date | When the action item has been completed, enter the date on which it was completed. Use the calendar to select the date or enter the date manually. |
| PV Agreement | The system automatically populates this field based on the details from the record. |
| Agreement Contact | The partner contact related to the Action Item. Select a PVA Contact from the picklist or select the binoculars icon to use filters and refine your search. |
| (Optional) Related PVA Obligation | The specific PVA clause related to the Action Item. Select an obligation from the picklist or select the binoculars icon to use filters and refine your search. |
| (Optional) Related PVA Activity | The specific activity within the PVA clause related to the Action Item. Select an activity from the picklist or select the binoculars icon to use filters and refine your search. Alternatively, select Create to create an activity. |
Obligations Section
In the Obligations section, create a record for each obligation outlined in the PVA.
Obligations are the contract terms formally defined within the PVA regarding the exchange of Safety information and are sometimes called ”clauses” or “commitments.” Each obligation is categorized according to the type of Safety data being shared.
Recording the exact wording, category, and related contacts of each obligation can help distinguish and keep track of each commitment that needs to be fulfilled to meet the PVA’s terms.
The tasks required for the fulfillment of these commitments can be recorded as Activities.
Select Create and complete the following fields to create an Obligation:
| Field | Description |
|---|---|
| Clause Title | Enter the name of the clause within which the obligation is outlined. This field supports up to 1,500 characters. |
| Obligation Category | The individual to whom the action item is assigned. Select a User from the picklist.
|
| Sponsor Contact | The sponsor contact from your organization related to the obligation. Select a PVA Contact from the picklist or select the binoculars icon to use filters and refine your search. |
| Partner Contact | The partner contact from your organization related to the obligation. Select a PVA Contact from the picklist or select the binoculars icon to use filters and refine your search. |
| Clause Wording | Enter the clause wording that describes the obligation. This field supports up to 5,000 characters. |
| Task Instructions | Enter the instructions for the task required to meet the obligation. The information entered here is populated on the activities linked to the obligation. This field supports up to 5,000 characters. |
Activities Section
In the Activities section, create a record for each activity.
Activities are the tasks that need to be undertaken in order to meet the obligations outlined within a PVA. Unlike action items, each activity is specifically linked to an obligation.
Recording the details, status, and people responsible for each activity can help you keep track of the fulfillment status of each obligation.
Select Create and complete the following fields to create an Activity:
| Field | Description |
|---|---|
| PVA Obligation | The specific PVA Obligation for which the activity needs to be completed. Select an obligation from the picklist or select the binoculars icon to use filters and refine your search. |
| Obligation Title | The title of the relevant obligation within the PVA. The system automatically populates this field based on the PVA Obligation field. This field supports up to 1,500 characters. |
| Due Date | Enter the date on which the activity is due for completion. Use the calendar to select the date or enter the date manually. |
| Completion Date | When the activity has been completed, enter the date on which it was completed. Use the calendar to select the date or enter the date manually. |
| Sponsor Responsible User | The individual from the sponsor organization who is responsible for the activity. Select a user from the picklist or select the binoculars icon to use filters and refine your search. |
| Partner Responsible Contact | The partner contact who is responsible for the activity. Select a user from the picklist or select the binoculars icon to use filters and refine your search. |
| Delivery Method | Select the preferred delivery method for this activity from the picklist. The available options include the following:
|
| Task Instructions | The system automatically populates this field based on the related obligation. This field supports up to 5,000 characters. |
| Activity Comments | Enter any additional comments related to the activity. This field supports up to 5,000 characters. |
For each activity, complete a PVA Activity workflow to keep track of all the tasks involved.
Reconciliations Section
In the Reconciliations section, record whether each obligation was met according to the terms of the PVA.
Each reconciliation links to a specific obligation and related activity within the PVA, and allows you to record whether this activity was completed on time, late, or not completed at all. You can also give reasons for any delays or cancellations.
These records are useful for establishing compliance to the PVA and also help inform decisions for future collaboration.
Select Create and complete the following fields to create an Reconciliation:
| Field | Description |
|---|---|
| Obligation | The specific PVA clause related to the reconciliation. Select an obligation from the picklist or select the binoculars icon to use filters and refine your search. |
| Obligation Name | The title of the relevant obligation within the PVA. The system automatically populates this field based on the Obligation field. |
| Activity | The specific activity within the PVA clause related to the reconciliation. Select an activity from the picklist or select the binoculars icon to use filters and refine your search. |
| Description | Enter a description for the reconciliation. This field supports up to 1,500 characters. |
| Assigned To | The individual to whom the related activity is assigned. Select a User from the picklist or select the binoculars icon to use filters and refine your search. |
| Due Date | Enter the date on which the related activity is due for completion. Use the calendar to select the date or enter the date manually. |
| Completion Date | When the related activity has been completed, enter the date on which it was completed. Use the calendar to select the date or enter the date manually. |
| Evaluation | Based on the activity’s completion status, select the appropriate evaluation from the picklist. |
| Reason | Enter any comments about the activity’s completion. This field supports up to 5,000 characters. |
Agreement Documents Section
In the Agreement Documents section, link agreements and other relevant documents that have been uploaded to the library.
Select Add to search for a document and add it to the record.
If your desired document does not appear in the search, select Create and complete the steps to upload a new document. See Add a Document to an Object Record for more information.
Signatures Section
As part of the PVA Approval workflow, users are prompted to provide eSignatures for document approval. These signatures are then automatically populated in the Signatures section on the PV Agreement.
PVA Workflows
Vault SafetyDocs supports the use of several workflows to keep track of the steps involved in PV Agreement management. The following sections describe the default workflows. Your Admin may configure your Vault with alternate steps based on your organization’s processes.
For more information, see Using Workflows.
PVA Creation Workflow
PVA Creation workflows can be used to follow each step in the PVA creation process, including document authoring, review, and approval. PVA Creation workflows include the following document workflows:
PVA Authoring Workflow
PVA Authoring workflows follow all the steps involved in drafting a PVA and sending it for review.
PVA Review Workflow
PVA Review workflows follow all the steps involved in reviewing a PVA and sending it for approval.
PVA Approval Workflow
PVA Approval workflows follow all the steps involved in approving a PVA.
PVA Activity Inbound Workflow
Inbound activities are tasks completed by partner organizations and sent to you in order to meet a PVA obligation. PVA Activity Inbound workflows are aligned with all the steps you would perform to verify the completion of the activity.
PVA Activity Outbound Workflow
Outbound activities are tasks completed by your organization and sent to partner organizations in order to meet a PVA obligation. PVA Activity Outbound workflows are aligned with all the steps you would perform to complete the activity and send it for approval.
PVA Close-Out Workflow
If a PVA needs to be terminated or if it has simply reached the end of its term, you can use a PVA Close-Out workflow to track all the steps involved in the close out process.
