# Manage PVA Multi-Agreement Activities 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_][9] and their documents on each related _PV Agreement_ * [Distribute PVA documents][10] to partner contacts via email * [Automate activity creation for monitored obligation events][12] ## Prerequisites To use _PVA Multi-Agreement Activities_, your Admin must enable: * Multi-Agreement Activities * PVA Management 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][11], 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 {#automated-activity-creation} 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: 1. [Creates a _PVA Multi-Agreement Activity_][1] for the event. 2. Identifies the _PVA Obligations_ related to the monitored event. 3. [Adds each identified _PVA Obligation_ to the _PVA Multi-Agreement Activity_][3]. 4. [Creates a _PVA MAA Document for Distribution_][4] to reference the related document, if the detected event is related to a PSMF or RMP document. 5. 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][9] to create new _PVA Activities_ for each linked _PVA Obligation_. ## Create a PVA Multi-Agreement Activity {#create-pva-maa} To create a _PVA Multi-Agreement Activity_: 1. Navigate to **PVAs > Multi-Agreement Activities**. 2. Select **Create**. 3. Complete the applicable [fields][2], 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_][3] Vault uses to generate its _PVA Activities_ and distribute its related documents. ### PVA Multi-Agreement Activity Fields {#pva-maa-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 {#add-pva-obligations} To add a _PVA Obligation_ to a _PVA Multi-Agreement Activity_: 1. Expand the **PVA Obligations** section. 2. Select **Add** to search for _PVA Obligations_. 3. Use the search bar and filters to refine your search, then select _PVA Obligations_ from the list. 4. Optional: If your desired obligation does not appear in the search results, select **Create** to create a _PVA Obligation_. 5. Select **OK**.
When [generating related activities][9], Vault creates a new _PVA Activity_ on each linked _PVA Obligation_. ### Add PVA MAA Documents for Distribution {#add-pva-maa-documents-for-distribution} To add a _PVA MAA Document for Distribution_ to a _PVA Multi-Agreement Activity_: 1. Expand the **PVA Multi-Agreement Doc for Distribution** section. 2. Select **Create**. 3. Complete the applicable [fields][5], 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_][3]. These _PVA Documents for Distribution_ determine which documents Vault distributes via email when the [_Distribute All Related PVA Documents_ action][10] is run. #### PVA MAA Document for Distribution Fields {#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 (binoculars-icon) 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 {#add-product-families} To add a _Product Family_ to a _PVA Multi-Agreement Activity_: 1. Expand the **Covered Product Families** section. 2. Select **Add** to search for _Product Families_. 3. Use the search bar and filters to refine your search, then select _Product Families_ from the list. 4. Optional: If your desired _Product Family_ does not appear in the search results, select **Create** to create a _Product Family_. 5. Select **OK**. ### Optional: Add Countries {#add-countries} To add a _Country_ to a _PVA Multi-Agreement Activity_: 1. Expand the **Covered Countries** section. 2. Select **Add** to search for _Countries_. 3. Use the search bar and filters to refine your search, then select _Countries_ from the list. 4. Optional: If your desired _Country_ does not appear in the search results, select **Create** to create a _Country_. 5. Select **OK**. ### Optional: Add Studies {#add-studies} To add a _Study_ to a _PVA Multi-Agreement Activity_: 1. Expand the **Covered Studies** section. 2. Select **Add** to search for _Studies_. 3. Use the search bar and filters to refine your search, then select _Studies_ from the list. 4. Optional: If your desired _Study_ does not appear in the search results, select **Create** to create a _Study_. 5. Select **OK**. ## Generate Related Activities {#generate-activities} After [adding obligations][3] and [documents for distribution][4] 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_: 1. Navigate to the _PVA Multi-Agreement Activity_. 2. From the **Workflow State Change** menu (Workflow-State-Button), select **Generate Related Activities**. 3. From the _Generate Related Activities?_ banner, select **Complete**. 4. 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 {#automated-intake} 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** (paper-plane-icon). ## Distribute All Related PVA Documents {#distribute-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_: 1. Navigate to the _PVA Multi-Agreement Activity_. 2. From the **Workflow State Change** menu (Workflow-State-Button), select **Distribute All Related PVA Documents**. 3. From the _Distribute Related Documents?_ banner, select **Complete**. 4. 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_][3], then sets the lifecycle state of the _PVA Multi-Agreement Activity_ and related _PVA Activities_ to _Sent to Partner_. ## Considerations When Editing Records {#considerations} 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_
Additionally, Vault prevents edits to any child _PVA Activities_ of any _PVA Obligations_ linked to the _PVA Multi-Agreement Activity_. [1]: #create-pva-maa [2]: #pva-maa-fields [3]: #add-pva-obligations [4]: #add-pva-maa-documents-for-distribution [5]: #pva-maa-document-for-distribution-fields [6]: #add-product-families [7]: #add-countries [8]: #add-studies [9]: #generate-activities [10]: #distribute-documents [11]: #automated-intake [12]: #automated-activity-creation [13]: #due-date