# Distribute PVA Documents via Email SafetyDocs provides a centralized process for sharing documents with partner organizations and tracking their activity directly from your Vault. Depending on the terms set out in your Pharmacovigilance Agreement (PVA), you can distribute documents from a _PVA Activity_ or _PVA Action Item_. This prompts Vault to send an email to the assigned recipient with a link that they can use to view the documents. You can leverage this functionality to share various documents managed in SafetyDocs, including but not limited to: - Pharmacovigilance System Master Files (PSMFs) - Aggregate reports - Literature reviews - Signal reports - Risk management plans - _Workbench Reports_ Once the documents have been sent, Vault tracks when the email has been delivered and, if possible, opened. These records enable you to closely track the progress of Activities and Action Items to ensure your organization is properly managing regulatory timelines and meeting PVA mandates. ## Prerequisite To use this feature, your Admin must enable PVA Document Distribution via Email.

Note: If your Admin has enabled Multi-Recipient PVA Document Distribution, you can distribute documents to up to 20 recipients from a PVA Activity.

## Overview To distribute documents to users via email from a _PVA Action Item_ or _PVA Activity_, you must: 1. [Create _PVA Documents for Distribution_][4]. 2. [Grant users access][5] to the relevant _PVA Action Item_ or _PVA Activity_. 3. [Distribute PVA documents][6]. ## Create PVA Documents for Distribution {#create-pva-documents-for-distribution} For each document that you want to distribute via email, create a _PVA Document for Distribution_ record: 1. Navigate to **PVAs > PV Agreements**. 2. Select the _PV Agreement_, then navigate to the _PVA Activity_ or _PVA Action Item_ under which you want to add a document for distribution. 3. In the _Documents for Distribution_ section, select **Create**. 4. On the _Create PVA Document for Distribution_ page, complete the [applicable fields][9] then select **Save**.

Note: To create a PVA Document for Distribution on a PVA Action Item, the PVA Action Item must have an Activity Type value of Outbound.

### PVA Document for Distribution Fields {#pva-document-for-distribution-fields} The following fields may be available:

Field	Description
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 version must be in a steady state to be eligible for distribution.
PV Agreement	Vault populates the PV Agreement related to the PVA Activity or PVA Action Item on which you create the PVA Document for Distribution.
Activity	When creating a PVA Document for Distribution from a PVA Activity, Vault populates the PVA Activity on which you are creating the PVA Document for Distribution. Alternatively, you can select a PVA Activity from the drop-down.
PVA Action Item	When creating a PVA Document for Distribution from a PVA Action Item, Vault populates the PVA Action Item on which you are creating the PVA Document for Distribution. Alternatively, you can select a PVA Action Item related to the document from the picklist or select the Advanced Search icon to use filters and refine your search. Note: If you specify both a PVA Activity and a PVA Action Item on a PVA Document for Distribution, Vault distributes only the document from the PVA Action Item.
Sent Date	Vault populates the date on which you run the Distribute PVA Document(s) action and send out the documents.
Link Expiry Date	Vault populates the date on which the link to access the documents will expire, which is always 30 days after the Sent Date.

### Automated Creation of PVA Documents for Distribution If your Admin has configured Automated Distribution of PVA Reports, Vault can automatically create _PVA Document for Distribution_ records and distribute documents from a _PVA Activity_, provided the _PVA Activity_ meets the following criteria: - The _PVA Activity_ was created from a Scheduled-type PVA Obligation - The parent _PVA Obligation_ has an Auto-Send Generated Document value of _Send After Generation_ - The _PVA Activity_ contains a document generated from either a _Vault Report_ or a _Workbench Report Set_ When these criteria are met, Vault distributes documents from the _PVA Activity_ at the intervals defined by the parent _PVA Obligation_'s _Schedule_, using [the same dispatch logic as the manual _Distribute PVA Document(s)_ action][6]. ## Grant User Access {#grant-user-access} To grant user access to a _PVA Action Item_ or _PVA Activity_ and its related documents and to run the Distribute PVA Document(s) action, you must populate the relevant [_PVA Action Item_][7] or [_PVA Activity_][8] fields with distribution information.

Note: Vault supports multi-recipient document distribution from PVA Activities only. This functionality does not extend to PVA Action Items, which support only a single recipient.

### PVA Action Item Fields {#pva-action-item-fields} To allow for distributing PVA documents to a user from a _PVA Action Item_, populate the following fields with the specified values:

Object	Field	Value
PVA Contact record of the User to whom you are granting access	Communication Method	Email
PVA Action Item	Agreement Contact	The PVA Contact to whom you are granting access
PVA Action Item	Partner Access	Access Granted

### PVA Activity Fields {#pva-activity-fields} In addition to the primary recipient specified in the _Partner Responsible Contact_ field of the _PVA Activity_, Vault can distribute documents and Vault tasks to up to 19 additional recipients. To allow for distributing PVA documents to selected users from a _PVA Activity_, populate the following fields with the specified values:

Object	Field	Value
PVA Contact record of the User to whom you are granting access	Communication Method	Email
PVA Obligation related to the PVA Activity	Partner Contact	The PVA Contact¹ to whom you are granting access
PVA Obligation related to the PVA Activity	Up to 19 PVA Contacts specified in the Additional Recipients section	Additional PVA Contacts¹ to whom you are granting access
PVA Activity	Partner Responsible Contact	The User to whom you are granting access
	Delivery Method	Email
	Partner Access	Access Granted
1. For Vault to generate emails from a PVA Activity, the Partner Contact and all additional PVA Contacts must have the same Communication Method value.

## Distribute PVA Documents {#distribute-pva-documents} Once you have created _PVA Documents for Distribution_ and granted access to all applicable recipients, distribute the documents: 1. Navigate to the _PVA Action Item_ or _PVA Activity_ from which you want to distribute the documents. 2. From the **Workflow State Change** menu ( Workflow-State-Button

), select **Distribute PVA Document(s)**. **Result** Vault sends an email to the following recipients, depending on the object on which you ran the **Distribute PVA Document(s)** action: - **PVA Action Item**: The _Agreement Contact_ on the _PVA Action Item_ - **PVA Activity**: - The _Partner Responsible Contact_ on the _PVA Activity_ in the email's "To" field - The _Partner Contact_ on the parent _PVA Obligation_ of the initiating _PVA Activity_, added to the email's "CC" field - Up to 19 _PVA Contacts_ specified in the _Additional Recipients_ section of the parent _PVA Obligation_, added to the email's "CC" field

Note: If the email fails to send from a PVA Activity, Vault sends an email to the Sponsor Responsible User on the PVA Activity to notify them of the error.

The email is made up of: - A subject line mapped from the _Message Subject_ value of the related _PVA Action Item_ or _PVA Activity_. - An email body mapped from the _Message Body_ value of the related _PVA Action Item_ or _PVA Activity_. - A link to view and download all the _PVA Documents for Distribution_ associated with the _PVA Action Item_ or _PVA Activity_. This link expires 30 days after the email is sent. You can send up to 1,000 documents via email at a time.

Note: Depending on your Admin’s configuration, Vault can send emails from a custom email domain and From Email Person address.

## Track PVA Document Distribution Events Once the email has been sent, Vault creates a _PVA Document Distribution Event_ on the _PV Agreement_ to track each interaction each recipient has with the email. Vault creates separate _PVA Document Distribution Events_ per recipient for each of the following events: - When the email is dispatched - When the email is delivered - When the email is opened, if the recipient's system allows - If any errors have been detected Each _PVA Document Distribution Event_ contains details such as its related _PVA Activity_ or _PVA Action Item_, as well as the exact time and type of the event.

Note: The creation of PVA Document Distribution Events may be delayed for up to one (1) hour after they occur.

[4]: #create-pva-documents-for-distribution [5]: #grant-user-access [6]: #distribute-pva-documents [7]: #pva-action-item-fields [8]: #pva-activity-fields [9]: #pva-document-for-distribution-fields