SafetyDocs supports creating PVA obligation activities that span multiple Pharmacovigilance Agreements (PVAs). In contrast to PVA Activities which exist in a one-to-one relationship with a single PVA Obligation, a PVA Multi-Agreement Activity can be related to multiple PVA Obligations across multiple PV Agreements, making it easier to manage activities required by multiple PVAs.
You can use a PVA Multi-Agreement Activity to:
- Generate PVA Activities and their documents on each related PV Agreement
- Distribute PVA documents to partner contacts via email
- Automate activity creation for monitored obligation events
Prerequisites
To use PVA Multi-Agreement Activities, your Admin must enable:
To distribute PVA documents via email, your Admin must enable PVA Document Distribution via Email.
To automate the intake of inbound obligation activity documents received via email, your Admin must enable Automated Inbound PVA Activity Email Processing.
To automate activity creation for monitored obligation events, your Admin must enable PVA: Event Based Activities.
Automated Activity Creation for Monitored Obligation Events
Depending on your Admin’s configuration, you can create PVA Obligations to monitor your Vault for specific events. Each time a monitored event is detected, Vault:
- Creates a PVA Multi-Agreement Activity for the event.
- Identifies the PVA Obligations related to the monitored event.
- Adds each identified PVA Obligation to the PVA Multi-Agreement Activity.
- Creates a PVA MAA Document for Distribution to reference the related document, if the detected event is related to a PSMF or RMP document.
- Sends a notification to the Sponsor Contact specified on each related PVA Obligation to inform them of the event.
Once complete, you can run the Generate Related Activities action to create new PVA Activities for each linked PVA Obligation.
Create a PVA Multi-Agreement Activity
To create a PVA Multi-Agreement Activity:
- Navigate to PVAs > Multi-Agreement Activities.
- Select Create.
- Complete the applicable fields, then select Save.
Select the Name of the PVA Multi-Agreement Activity to navigate to the record and define its related objects, including the PVA Obligations Vault uses to generate its PVA Activities and distribute its related documents.
PVA Multi-Agreement Activity Fields
The following fields may be available:
| Field | Description |
|---|---|
| Name |
Enter a name. When creating a PVA Multi-Agreement Activity upon detection of a monitored obligation event, Vault populates a value that includes the monitored event type. |
| Activity Comments | Enter any additional comments related to the activity. |
| Activity Type |
Select a value from the picklist to define whether the activity is inbound (completed by a partner organization) or outbound (completed by your organization and sent to a partner organization). When creating a PVA Multi-Agreement Activity upon detection of a monitored obligation event, Vault populates Outbound. |
| Message Subject | Enter a message subject. Vault uses this value to define the email subject line when you distribute documents to partners via email. |
| Message Body | Enter message body content. Vault uses this value to define the email body when you distribute documents to partners via email. |
| Delivery Method | Select a delivery method from the picklist to define how documents related to the PVA Multi-Agreement Activity will be distributed. |
| Due Date |
Enter a due date to define when this activity needs to be completed, based on the terms defined in any related PVA Obligations. Use the calendar to select the date or enter the date manually. Depending on your Admin's configuration, the value you select may determine the Due Date of PVA Activities created as a result of the Generate Related Activities action. |
| Earliest Due Date |
Vault populates the earliest due date among all PVA Obligations on the PVA Multi-Agreement Activity based on their Obligation Timeline and Timeline Days values. Vault determines the Due Date by adding the number of Timeline Days to the date the action is run, accounting for either weekdays or calendar days, as specified. If a PVA Obligation has an Obligation Timeline value not specified in days, Vault does not consider it when calculating the Earliest Due Date. |
Add PVA Obligations
To add a PVA Obligation to a PVA Multi-Agreement Activity:
- Expand the PVA Obligations section.
- Select Add to search for PVA Obligations.
- Use the search bar and filters to refine your search, then select PVA Obligations from the list.
- Optional: If your desired obligation does not appear in the search results, select Create to create a PVA Obligation.
- Select OK.
Note: PVA Multi-Agreement Activities support only Manual-type PVA Obligations.
When generating related activities, Vault creates a new PVA Activity on each linked PVA Obligation.
Add PVA MAA Documents for Distribution
To add a PVA MAA Document for Distribution to a PVA Multi-Agreement Activity:
- Expand the PVA Multi-Agreement Doc for Distribution section.
- Select Create.
- Complete the applicable fields, then select Save.
Vault uses PVA MAA Documents for Distribution to create PVA Documents for Distribution on all related child PVA Activities of any linked PVA Obligations. These PVA Documents for Distribution determine which documents Vault distributes via email when the Distribute All Related PVA Documents action is run.
PVA MAA Document for Distribution Fields
The following fields may be available:
| Field | Description |
|---|---|
| Name | Enter a name. |
| Document for Distribution | Select the document you want to distribute from the picklist or select the Advanced Search ( ) icon to use filters and refine your search. |
| Version | Select the version of the document you want to distribute from the picklist. The selected document must be in a steady state to be eligible for distribution. |
Optional: Add Product Families
To add a Product Family to a PVA Multi-Agreement Activity:
- Expand the Covered Product Families section.
- Select Add to search for Product Families.
- Use the search bar and filters to refine your search, then select Product Families from the list.
- Optional: If your desired Product Family does not appear in the search results, select Create to create a Product Family.
- Select OK.
Optional: Add Countries
To add a Country to a PVA Multi-Agreement Activity:
- Expand the Covered Countries section.
- Select Add to search for Countries.
- Use the search bar and filters to refine your search, then select Countries from the list.
- Optional: If your desired Country does not appear in the search results, select Create to create a Country.
- Select OK.
Optional: Add Studies
To add a Study to a PVA Multi-Agreement Activity:
- Expand the Covered Studies section.
- Select Add to search for Studies.
- Use the search bar and filters to refine your search, then select Studies from the list.
- Optional: If your desired Study does not appear in the search results, select Create to create a Study.
- Select OK.
Generate Related Activities
After adding obligations and documents for distribution to a PVA Multi-Agreement Activity, you can run the Generate Related Activities action to create new PVA Activities for each linked PVA Obligation, simplifying the process of creating activities that span multiple obligations.
To generate activities for a PVA Multi-Agreement Activity:
- Navigate to the PVA Multi-Agreement Activity.
- From the Workflow State Change menu (
), select Generate Related Activities. - From the Generate Related Activities? banner, select Complete.
- In the Generate Related Activities? dialog, select Generate Activities, then select Complete.
Once complete, Vault:
- Adds a new PVA Activity on each linked PVA Obligation
- Populates each new PVA Activity with:
- Data and documents from the PVA Multi-Agreement Activity
- A Due Date value
- Updates the lifecycle state of each new PVA Activity to Active
- Updates the lifecycle state of the PVA Multi-Agreement Activity to In Progress
Automated Email Intake of PVA Activity Documents
Depending on your Admin’s configuration, Vault can automate the intake of inbound obligation documents for PVA Activities on a PVA Multi-Agreement Activity. After selecting Generate Related Activities on the PVA Multi-Agreement Activity, Vault additionally sends a notification email to the partner contacts on each of its associated PVA Activities to request the relevant documents required to complete the activity.
If the partner contacts do not respond to this notification email, you can send a reminder notification email. From the All Actions menu of the PVA Multi-Agreement Activity, select Send Inbound Activity Reminder (
).
Distribute All Related PVA Documents
Once your PVA Multi-Agreement Activity contains all of the required activities, you can run the Distribute All Related PVA Documents action to distribute all documents to partner contacts via email.
To distribute documents from a PVA Multi-Agreement Activity:
- Navigate to the PVA Multi-Agreement Activity.
- From the Workflow State Change menu (), select Distribute All Related PVA Documents.
- From the Distribute Related Documents? banner, select Complete.
- In the Distribute Related Documents? dialog, select Distribute Documents, then select Complete.
Vault sends email distributions for all PVA Documents for Distribution of any child PVA Activities on any linked PVA Obligations, then sets the lifecycle state of the PVA Multi-Agreement Activity and related PVA Activities to Sent to Partner.
Considerations When Editing Records
To reduce the manual effort associated with editing related records and to prevent data integrity issues, Vault applies edits from the PVA Multi-Agreement Activity to its related records in the following scenarios:
- When you edit a PVA Multi-Agreement Activity, Vault applies those edits to any child PVA Activities on any linked PVA Obligations.
- When you add a new PVA MAA Document for Distribution to a PVA Multi-Agreement Activity, Vault creates a PVA Document for Distribution on any child PVA Activities on any linked PVA Obligations.
- When you edit an existing PVA MAA Document for Distribution, Vault applies those edits to any linked PVA Documents for Distribution.
- Vault clears the PVA Multi-Agreement Activity field, removing the relationship between these records from any child PVA Activities on any linked PVA Obligations, in the following scenarios:
- When you remove a PVA Obligation from a PVA Multi-Agreement Activity
- When you add or remove a PVA Document for Distribution from a child PVA Activity
Note: Once this relationship is removed, changes to the PVA Multi-Agreement Activity will no longer be reflected on previously related PVA Activities.
Additionally, Vault prevents edits to any child PVA Activities of any PVA Obligations linked to the PVA Multi-Agreement Activity.