# Manage Pharmacovigilance Agreements 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 or more organizations that share safety data such as Individual Case Safety Reports (ICSRs), periodic reporting, literature monitoring, and signal detection. PVAs may be required when: * Non-sponsor organizations receive safety data on behalf of sponsor organizations * Partner organizations are co-licensed to manufacture or market products * Partner organizations are Marketing Authorization Holders (MAHs) in different markets Vault makes it easy to manage PVAs between partner organizations, helping you to maintain regulatory compliance by allowing you to: * Author, review, and manage your [PVA documents][18] * [Generate draft PVA documents][23] with predefined clauses * [Centralize all PVAs made with a specific partner organization][2] * Create a [_PV Agreement_][3] for each agreement you make with a partner organization and use it to track PVA details like effective and expiration dates and the [_Product Families_][24], [_Studies_][25], and [_Countries_][26] it covers * Manage [action items][4] you need to complete in order to fulfill your PVAs * Manage [obligations][5] and their related inbound and outbound [activities][6], including: * The ability to [set predefined schedules][0] that create activities at specified intervals * [Automated intake of obligation activity documents received via email][31] * [Automated activity creation for monitored obligation events][37] * Manage [contacts][7] to ensure smooth collaboration and timely obligation [reconciliation][8] * Use [workflows][9] to keep track of each step of the PVA management process, from creation to close-out * Configure additional parameters for tracking ## Prerequisites To use this feature, your Admin must enable: * PVA Management * Generate Draft Pharmacovigilance Agreement Documents * Automated Inbound PVA Activity Email Processing * PVA: Event Based Activities ## PVA Scheduling To simplify managing recurring PVA obligations, SafetyDocs offers automated PVA scheduling, supporting on-time reporting and reducing manual workload. When creating a _Scheduled_-type [_PVA Obligation_][10], you select a predefined schedule, enabling Vault to automate the creation of _PVA Activities_ and report documents at the appropriate intervals. Whenever the schedule runs, Vault: - Creates the obligation's child _PVA Activities_. - (Optional) Runs the associated report (either _Source Vault Report_ or _Source Workbench Report Set_), uploads the report documents to your _Library_ in the specified format (_Source Report Format_), and associates the report documents to the related _PVA Activity_ record. - Assigns new _PVA Activities_ to the appropriate user, allowing them to download and circulate the report to the relevant parties to satisfy the PVA obligation. To manage PVA schedules, you can: - [Schedule _PVA Obligations_][11] - [Cancel _PVA Obligations_][12] - [Update obligation dates][13] ### Schedule PVA Obligations You can schedule _PVA Obligations_ from either a [_PV Agreement_][14] or a [_PVA Obligation_][15]. For each _PVA Activity_ created using this action, Vault sets the fields as follows:
Field Description
PV Agreement The PV Agreement linked to the parent PVA Obligation
Obligation The parent PVA Obligation driving the Schedule that created the PVA Activity
Due Date The date the PVA Activity needs to be completed, based on the Scheduled Event run date and the Activity Creation Days Prior value of the PVA Obligation
Activity Type The Obligation Direction value on the parent PVA Obligation
#### Schedule PVA Obligations for PV Agreements To schedule activities for all _Scheduled_-type _PVA Obligations_ on a _PV Agreement_: 1. Navigate to **PVAs > PV Agreements**. 2. Select the desired **PV Agreement**. 3. From the **All Actions** menu, select **Schedule PVA Obligations**. **Result** For each _Scheduled_-type _PVA Obligation_ child record on the originating _PV Agreement_, Vault creates a _PVA Activity_ at the intervals defined by the _Schedule_ on the _PVA Obligation_. Vault determines which date to create each _PVA Activity_ using the following priority order: - The _PVA Obligation_'s _Start Date_ value - The originating _PV Agreement_'s _Effective Date_ value - The date you run the _Schedule PVA Obligations_ action When the _PVA Obligation_'s _Start Date_ field is blank, Vault populates the date the _Schedule PVA Obligations_ action was run. #### Schedule a PVA Obligation from a PVA Obligation Record
To schedule activities for a single _PVA Obligation_: 1. Navigate to **PVAs > PV Agreements**. 2. Select the desired **PV Agreement**. 3. Navigate to the _Obligations_ page and select the desired **PVA Obligation**. 4. From the **All Actions** menu, select **Schedule PVA Obligation**. **Result** Vault creates _PVA Activities_ on the originating _PVA Obligation_ at the intervals defined by the _Schedule_ on the _PVA Obligation_. Vault determines which date to create each _PVA Activity_ using the following priority order: - The _PVA Obligation_'s _Start Date_ value - The date you run the _Schedule PVA Obligation_ action When the _PVA Obligation_'s _Start Date_ field is blank, Vault populates the date the _Schedule PVA Obligation_ action was run. ### Cancel Scheduled Obligations {#cancel-scheduled-obligations} You can prevent a schedule from creating any future _PVA Activities_ from a [_PV Agreement_][16] or a [_PVA Obligation_][17]. #### Cancel PVA Obligations from a PV Agreement Record To cancel activities for all _PVA Obligations_ on a _PV Agreement_: 1. Navigate to **PVAs > PV Agreements**. 2. Select the desired **PV Agreement**. 3. From the **All Actions** menu, select **Cancel Scheduled Obligations**. **Result** Vault cancels all future events by: - Preventing the _Schedule_ from creating any future _PVA Activities_ - Setting the _Schedule Recurrences_ to the _Cancelled_ state - Setting the _End Date_ value to today for all _Cancelled_-state _PVA Obligations_ - Deleting any _Scheduled Events_ #### Cancel PVA Obligations from a PVA Obligation Record To cancel activities for a single _PVA Obligation_: 1. Navigate to **PVAs > PV Agreements**. 2. Select the desired **PV Agreement**. 3. Navigate to the _Obligations_ page and select the desired **PVA Obligation**. 4. From the **All Actions** menu, select **Cancel Scheduled Obligation**. **Result** Vault cancels all future events by: - Setting the _Schedule Recurrences_ to the _Cancelled_ state - Setting the _End Date_ value to today for all _Cancelled_-state _PVA Obligations_ - Deleting any _Scheduled Events_ ### Update Obligation Dates You can update obligation dates for all _PVA Activities_ on a _PVA Obligation_. The process depends on the type of _Schedule_ selected on the _PVA Obligation_ as follows: * [_PVA Obligations_ on a _Schedule_ without specified days][19] * [_PVA Obligations_ on a weekly or monthly _Schedule_ with specified days of the week][20] (for example, a _Weekly_ _Schedule_ with a _Days to Run_ value, or a _Last Day of the Month_ _Schedule_)
#### Update Obligation Dates for Schedules Without Specified Days {#update-obligation-dates-without-specified-days} To update the obligation dates for all _PVA Activities_ on a _PVA Obligation_: 1. Navigate to **PVAs > PV Agreements**. 2. Select the desired **PV Agreement**. 3. Navigate to the _Obligations_ page and select the desired **PVA Obligation**. 4. Navigate to the _Activities_ page and select the desired **PVA Activity**. 5. From the **All Actions** menu, select **Update all Activity Dates**. 6. Use the calendar to select a date or enter the date manually. 7. Select **Save**. Vault updates the _Due Date_ field value to the specified date for the following records: - The originating _PVA Activity_ record - All future scheduled _PVA Activities_ linked to the parent _PVA Obligation_ record - Any existing _PVA Activities_ on the parent _PVA Obligation_ record, provided the _PVA Activity_ record is in one of the following states: - _New_ - _In Progress_ - _Received from Partner_ - _Sent to Partner_ - _Inactive_ #### Update Obligation Dates for Schedules With Specified Days of the Week {#update-obligation-dates-specified-days} To update obligation dates for _PVA Activities_ on a _PVA Obligation_ that recurs on a specific day of the week or first or last day of the month: 1. [Cancel scheduled obligations][21]. 2. Update the [_Schedule_][22] value on the _PVA Obligation_ to reflect your desired schedule. ## Create a PVA Relationship {#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 _PVA Relationship_ record for each partner organization and link it to the PVAs made with them. This helps you maintain compliance and manage current and future collaboration by keeping track of all agreed-upon data exchange obligations, as well as their related activities and reconciliations. To create a _PVA Relationship_:
  1. Navigate to PVAs > PVA Relationships.
  2. Select Create.
  3. Complete the fields on the Create PVA Relationship page.
  4. 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 {#create-a-pv-agreement} To create a _PV Agreement_: 1. Navigate to **PVAs > PV Agreements**. 2. Select **Create**. 3. On the _Create PV Agreement_ page, complete the [applicable fields][27]. 4. Select **Save**. Once you save the _PV Agreement_, the following sections appear. Complete the applicable sections according to your business processes. Then, complete a [PVA Creation workflow][32] to track all the steps involved in authoring, reviewing, and approving the agreement. ### PV Agreement Fields {#pv-agreement-fields} The following fields may be available:
Field Description
Agreement Title Enter the title of the agreement.
Relationship Select the relevant PVA Relationship from the drop-down or select Create to add a new one.
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.
Agreement Effective Date

Enter the start date for the agreement. Use the calendar to select the date or enter the date manually.

Depending on your Admin's configuration, Vault may use this value to define when to move the PV Agreement and its related approved documents to the Effective state, provided the PV Agreement is in the Pending Effective state.
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.
Originating Email Select a From Email Person object type. If your Admin has configured custom outbound emails, Vault uses the email of the selected Person to populate the From field when distributing PVA documents via email or sending notification emails related to automated intake of PVA Activity documents.
PV Agreement Type Select an agreement type.
PVA Outline Select a PVA Outline. Vault uses this PVA Outline to generate a draft PVA document for the PV Agreement when you run the Generate Draft PVA action.
Inbound Email Address Select an Inbound Email Address from the picklist to allow related PVA Activities to automate the intake of documents received via email.
Marketing Authorization Holder Identify which party is the Marketing Authorization Holder (MAH) for this agreement.
Global Safety Database Holder Identify which party is the Global Safety Database Holder (GSDH) for this agreement.
### Covered Products Section To add _Products_ to a _PV Agreement_: 1. In the _Covered Products_ section, select **Add**. 2. Use the search bar and filters to select _Products_ from the list. 3. Select **OK**. ### Covered Product Families Section {#covered-product-families} To add _Product Families_ to a _PV Agreement_: 1. In the _Covered Product Families_ section, select **Add**. 2. Use the search bar and filters to select _Product Families_ from the list. 3. Select **OK**. ### Covered Studies Section {#covered-studies} To add _Studies_ to a _PV Agreement_: 1. In the _Covered Studies_ section, select **Add**. 2. Use the search bar and filters to select one or more _Studies_ from the list. 3. Select **OK**. ### Covered Countries Section {#covered-countries} To add _Countries_ to a _PV Agreement_: 1. In the _Covered Countries_ section, select **Add**. 2. Use the search bar and filters to select one or more _Countries_ from the list. 3. Select **OK**. ### Contacts Section To create _PVA Contacts_ for a _PV Agreement_: 1. In the _Contacts_ section, select **Create**. 2. On the _Create PVA Contact_ page, complete the applicable [fields][28]. 3. Select **Save**. #### Contact Fields {#contact-fields} The following fields may be available:
Field Description
Vault User The Vault User profile of the contact. Select a User from the picklist or select the Advanced Search (binoculars-icon) 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 Advanced Search icon to use filters and refine your search.
Contract Party Select whether the contact is related to the Sponsor or Partner.
Communication Method Select the preferred communication method for this contact from the picklist:
  • Email
  • Manual
  • Vault Task
### Action Items Section The _Action Items_ section of a _PV Agreement_ allows you to create a _PVA Action Item_ for each task that needs to be undertaken in order to create and fulfill a PVA, such as authorship, monitoring, or general management of its activities. _PVA 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 _PVA Action Item_ is useful for tracking and compliance purposes. From the _Action Items_ section, select **Create** and complete the applicable fields to create a _PVA Action Item_:
Field Description
Name Vault populates a unique identifier.
Description Enter a description for the action item.
Assigned To Select the individual User to whom the action item is assigned 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 Vault populates the parent PV Agreement.
Agreement Contact Select the PVA Contact for the partner contact related to the action item from the picklist.
PVA Obligation To define the specific PVA clause related to the action item, select a PVA Obligation from the picklist.
Related Activity To define the specific activity within the PVA clause related to the action item, select a PVA Activity from the picklist.
Activity Type If your action item is linked to a PVA Activity, choose the type of activity from the picklist.
Contact Communication Method Vault populates the communication method of the user defined in the Agreement Contact field.
Message Subject When you distribute related documents to partners via email, this value defines the email's subject.
Message Body When you distribute related documents to partners via email, this value defines the email's body.
Partner Access When you distribute related documents to partners via Vault task, select Access Granted to allow the user in the Agreement Contact field to access this PVA Action Item and any related documents, provided the Agreement Contact is a Vault User.
### Obligations Section The _Obligations_ section of a _PV Agreement_ allows you to create _PVA Obligations_ for each obligation outlined in the PVA. Obligations, sometimes called clauses or commitments, are the contract terms formally defined within the PVA regarding the exchange of safety information. 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 between and keep track of each commitment that needs to be fulfilled to meet the PVA's terms. To create a _PVA Obligation_: 1. Navigate to the appropriate _PV Agreement_. 2. Expand the _Obligations_ section. 3. Select **Create**. 4. In the _Create PVA Obligation_ dialog, select the obligation type to define the obligation as either manual or [scheduled][0]. 5. Populate the [applicable fields][33], then select Save. #### 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. When Vault detects a monitored event, Vault creates a series of object records to support addressing it. For Vault to monitor your Vault for specific events, a _PVA Obligation_ must: * Have a _PVA Obligation Type_ value of _Manual Obligation_ * Have a [valid _Obligation Category_ value][38] * Have the [_Activities Triggered by Events?_][39] checkbox selected * Have an _Obligation Direction_ value of _Outbound_ or _Both_ * Have a _Responsible Party_ value * Be in the _Active_ state and its related _PV Agreement_ must be in the _Effective_ state Vault considers the following _Obligation Category_ values when determining the type of event to monitor: * **PSMF event**: To allow Vault to detect when a _PSMF Generated PDF_ document moves into the _Final_ state, select **PSMF Management**. * **RMP event**: To allow Vault to detect when a _Core RMP_ document moves into the _Approved_ state, select **Risk Management**. * Vault considers a _PVA Obligation_ to be related to a monitored RMP event if the _Product Family_ on the _Core RMP_ related to the _Core RMP_ document matches a [_Product Family_ on the _PV Agreement_][24] related to the _PVA Obligation_. * **Signal event**: To allow Vault to detect when a _Safety Investigation_ enters the _Risk Mitigation_ state, select **Signal Management**. * Vault considers a _PVA Obligation_ to be related to a monitored signal event if the _Product Family_ on the _Safety Investigation_ matches a [_Product Family_ on the _PV Agreement_][24] related to the _PVA Obligation_, or if the _Product Family_ field on the _Safety Investigation_ is blank. #### PVA Obligation Fields {#pva-obligation-fields} The following fields may be available:
Field Description
Clause Title Enter the name of the clause within which the obligation is outlined.
Obligation Category Select the obligation category from the picklist.
Aggregate Report Type If the Obligation Category is Periodic Reporting, select the types of aggregate report that apply to this obligation.
ICSR Type If the Obligation Category is ICSR Reporting, select the types of Individual Case Safety Report (ICSR) that apply to this obligation.
Activities Triggered by Events? Select this checkbox to allow Vault to create PVA Multi-Agreement Activities for this obligation upon detecting a monitored event.
Responsible Party Select the party responsible for the PVA. Vault may use this value when determining whether this obligation is related to a monitored event.
Shared Responsibility Detail If the Responsible Party is Both Parties Jointly, select the division of PVA responsibilities across the parties.
Sponsor Contact

Select a sponsor PVA Contact related to the obligation from the picklist or select the Advanced Search (binoculars-icon) icon to use filters and refine your search.

Vault may send a notification to this contact upon detecting a monitored event.
Partner Contact

Select a partner PVA Contact related to the obligation from the picklist or select the Advanced Search icon to use filters and refine your search.
Schedule

This field appears only on Scheduled-type PVA Obligations.

Select the Schedule that the obligation follows. Vault uses this value to define how often to create the related PVA Activities and report documents for the obligation.1
Days to Run

This field appears only when Weekly is selected in the Schedule field.

Use the picklist to select each day of the week on which you want the Schedule to run. Vault uses this value to define the days on which to create the related PVA Activities and report documents for the obligation. At least one day must be selected.1
Activity Creation Days Prior

This field appears only on Scheduled-type PVA Obligations.

Enter a numerical value between one and 30 to define how many days in advance of the Due Date Vault should create a PVA Activity. This allows you to determine how much warning different obligations should have.1

When using a First Day of the Month or Last Day of the Month Schedule, Vault uses this value to create PVA Activities the specified number of days in advance of the first or last day of the month, respectively, rather than in advance of the Due Date.
Obligation Direction

Select an Obligation Direction from the picklist to define whether the obligation is received from a partner (Inbound), sent to a partner (Outbound), or both.

Depending on your Admin's configuration:
Start Date

Enter the date the obligation comes into effect. For Scheduled-type PVA Obligations, Vault starts running the selected Schedule on this date.

If this field is blank, Vault populates the date when Vault schedules the PVA Obligation.1
End Date

This field appears only on Scheduled-type PVA Obligations.

Enter the date the obligation ends.1
Obligation Timeline

Select the timeline on which this obligation is monitored.

Vault may use this value and the Timeline Days value when determining due dates for PVA Activities created from a PVA Multi-Agreement Activity.
Timeline Days If you selected In Weekdays or In Calendar Days in the Obligation Timeline field, enter a number Vault will use to determine due dates for PVA Activities created from a PVA Multi-Agreement Activity.
Timeline Details If you selected Milestone in the Obligation Timeline field, enter details about the specified timeline values.
Clause Wording Enter the clause wording that describes the obligation.
Task Instructions

Enter the instructions for the task required to meet the obligation. Vault uses this field value to populate the Task Instructions field of any PVA Activity linked to the obligation.
Source Vault Report

This field appears only on Scheduled-type PVA Obligations.

Select a Report from the picklist or select the Advanced Search icon to use filters and refine your search.

Whenever the selected Schedule runs (generates PVA Activities), Vault generates the following for the Report:

  • A document of type Pharmacovigilance Agreements > Agreement Activities > PVA Distribution in your Library
  • A PVA Document for Distribution record to allow you to distribute the document via email or Vault task
Source Report Format

This field appears only on Scheduled-type PVA Obligations.

Select a report format to define the format in which Vault generates the Source Vault Report documents.
Source Report Prompt

This field appears only on Scheduled-type PVA Obligations.

If your Source Vault Report has additional parameters, this is the string of characters identifying the specific parameters related to the document you want to generate.

From the report's URL, copy the string of characters after the question mark (?) until the end of the URL and paste it into this field. If your report uses filters, you can include tokens in the Source Report Prompt field to represent the filtered fields.
Source Workbench Report Set

This field appears only on Scheduled-type PVA Obligations.

Select a Workbench Report Set from the picklist or select the Advanced Search icon to use filters and refine your search.

Whenever the selected Schedule runs (generates PVA Activities), Vault runs the Workbench Report Set and generates the following for each Workbench Report included in the Workbench Report Set:

  • A document of type Pharmacovigilance Agreements > Agreement Activities > PVA Distribution in your Library
  • A PVA Document for Distribution record to allow you to distribute the document via email or Vault task
Auto-Send Generated Document

This field appears only on Scheduled-type PVA Obligations.

Select Send After Generation to allow Vault to automatically distribute the generated Source Vault Report or Source Workbench Report Set documents to recipients via email or Vault task.
Additional Recipients Select Create to add up to 18 additional PVA Contacts to the PVA Obligation. Vault sets these PVA Contacts and the Partner Contact as additional recipients when distributing PVA documents from a PVA Activity via email or Vault task.
1. If a PVA Obligation has an active schedule, you cannot edit the following fields:
  • Schedule
  • Start Date
  • End Date
  • Days to Run
  • Activity Creation Days Prior
#### Tokens for Source Report Prompts If the report selected in the _Source Vault Report_ field uses filters, the _Source Report Prompt_ field allows you to configure a dynamic report using tokens that represent the filtered fields. Every time Vault generates a document from the report, Vault updates token values with the latest related field values, eliminating the need to manually update report filters every time you run the report. Vault supports the following tokens in the _Source Report Prompt_ field:
Token Source Field
${Activity.DueDate} The Due Date field on the PVA Activity object
${Agreement} The ID field on the PV Agreement object
${Obligation} The ID field on the PVA Obligation object
${Relationship} The ID field on the PVA Relationship object
${Relationship.Partner} The Partner field on the PVA Relationship object
### Activities Sections {#activities-section} The _Activities_ sections of a _PV Agreement_ allow you to create a _PVA Activity_ for each task that needs to be undertaken in order to meet the obligations outlined within the PVA. _PV Agreements_ contain different sections for different types of activities, such as case processing activities, ICSR activities, literature activities, and more. A _PVA Activity_ is considered either inbound or outbound, depending on whether it is completed by a partner organization and sent to your organization, or completed by your organization and sent to a partner organization. Unlike [_PVA Action Items_][4], each _PVA Activity_ is linked to a specific [_PVA Obligation_][5]. Recording the details, status, and people responsible for each _PVA Activity_ can help you keep track of the fulfillment status of each obligation. For each _PVA Activity_, you can complete a [_PVA Activity_ workflow][30] to keep track of all the tasks involved. From the relevant _Activities_ section, select **Create** and complete the [applicable fields][34] to create a _PVA Activity_.
#### Automated Email Intake of PVA Activity Documents {#automated-intake} Depending on your Admin's configuration, Vault can automate the intake of inbound obligation activity documents received via email. This functionality streamlines communication by allowing partners to email documents directly to a specific _PVA Activity_, with Vault providing immediate status updates to the sender regarding receipt, completion, or necessary corrections required for their PVA activities. For Vault to automate the intake of documents received via email for a specific _PVA Activity_: * The related [_PV Agreement_][3] must have an _Inbound Email Address_ value * The related [_PVA Obligation_][5] must have an _Obligation Direction_ value of _Inbound_ ##### Request and Receive Inbound PVA Activity Documents {#request-receive-documents} After you have created a _PVA Activity_, select the **Send Inbound Activity Reminder** (paper-plane-icon) icon from the **All Actions** menu to send a notification email to the _Partner Contact_ and any _Additional Recipients_ specified on the related [_PVA Obligation_][5] (also known as partner contacts). This email informs the partner contacts that the _PVA Activity_ is due and requests the relevant documents required to complete the activity.
When a partner contact replies to a notification email1, Vault reviews their email, uploads the contents to your _Library_ as documents, classifies each document under the _Pharmacovigilance Agreements > Agreement Activities_ subtype, and adds each document to the _Related Documents_ section of the _PVA Activity_ as follows: * **Email source content**: Vault uploads the email source content (the senders, recipients, subject line, message body, and more) classified as _PVA Correspondence_, using the subject line to populate the document's _Name_ field. * **Email attachments**: Vault uploads each attachment file classified as _PVA Distribution_, using the attachment file name to populate the document's _Name_ field. After adding each document to the _PVA Activity_, Vault updates the _PVA Activity_ to the _Received from Partner_ lifecycle state, then sends notification emails to the partner contacts and _Sponsor Contact_ specified on the related _PVA Obligation_ to acknowledge that Vault successfully received the activity documents.
##### Review and Approve Inbound PVA Activity Documents {#review-approve-documents} Once you have received the required documents from your partner contacts, select the **Workflow Actions** (Workflow-State-Button) menu from the _PVA Activity_, then select **Review and Approve Partner Documents**. This initiates the [_PVA Activity Inbound_ workflow][36], allowing you to assign reviewers to confirm receipt of all required documents. Once all reviewers indicate a verdict for their review task, Vault updates the _PVA Activity_ lifecycle state and sends notification emails to the partner contacts based on the selected review task verdicts: * If one or more reviewers selected **Additional Follow Up Required**, Vault: * Moves the _PVA Activity_ to the _Inbound Activity Requires Follow Up_ state * Sends a notification email to the partner contacts, indicating that one or more _PVA Activity_ documents require changes to be accepted and specifying the changes needed using the text entered in the _Partner Corrections Needed_ field of each workflow task * If a partner contact replies to the email, Vault moves the _PVA Activity_ back to the _Partner Documents Received_ state, allowing you to reinitiate the review workflow * If all reviewers select **All Documents Received**, Vault: * Moves the _PVA Activity_ to the _Complete_ state * Sends an email to the partner contacts indicating that their documents have been approved and the _PVA Activity_ has been completed If any errors occur at any point during the email intake process, Vault sends a notification email to the address that sent the error-causing email. #### PVA Activity Fields {#pva-activity-fields} The following fields may be available:
Field Description
Related Obligation Select the PVA Obligation for which the activity needs to be completed from the picklist.
Obligation Category Vault populates the category of the related PVA Obligation.
Obligation Title Vault populates the title of the related PVA Obligation.
Activity Type Select the type of activity from the picklist:
  • Inbound: Tasks that are completed by partner organizations to be sent to your organization.
  • Outbound: Tasks that are completed by your organization to be sent to partner organizations.
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.

When a PVA Activity is created as a result of the Generate Related Activities action, Vault calculates the due date based on the Obligation Timeline and Timeline Days values of the related PVA Obligation.

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.

For example, if the action is run on a Thursday and the Timeline Days value is 3, Vault calculates the due date as follows, depending on its Obligation Timeline value:

  • In Weekdays: Vault populates the next Tuesday
  • In Calendar Days: Vault populates the next Sunday

If the Obligation Timeline value is not specified in days, Vault uses the Due Date value on the PVA Multi-Agreement Activity.
Completion Date Once 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 Select the User from the sponsor organization who is responsible for the activity from the picklist.
Partner Responsible Contact Select the PVA Contact for the partner contact who is responsible for the activity from the picklist.
Activity Inbound Email Address Vault populates a unique email address by combining the Inbound Email Address value on the related PV Agreement with a unique identifier for the PVA Activity. When this field is populated, Vault automates the intake of documents for the PVA Activity.
Task Instructions Vault populates the task instructions of the related PVA Obligation.
Activity Comments Enter any additional comments related to the activity.
Delivery Method Select the preferred delivery method for this PVA Activity from the picklist:
  • Email
  • Manual
  • Vault Task
Message Subject When you distribute related documents to partners via email, this value defines the email's subject.
Message Body When you distribute related documents to partners via email, this value defines the email's body.
Partner Access When you distribute related documents to partners via Vault task, select Access Granted to allow the user in the Partner Responsible Contact field to access this PVA Activity and any related documents, provided the Partner Responsible Contact is a Vault User.
### Reconciliations Section In the **Reconciliations** section, record whether each obligation was met according to the terms of the PVA. Each _PVA Reconciliation_ links to a specific _PVA Obligation_ and related _PVA Activity_ within the PVA, and allows you to record whether this _PVA 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 a _PVA Reconciliation_:
Field Description
Obligation The specific PVA clause related to the reconciliation. Select a PVA Obligation from the picklist or select the Advanced Search (binoculars-icon) icon to use filters and refine your search.
Obligation Name The title of the relevant obligation within the PVA. Vault automatically populates this field based on the PVA Obligation field.
Activity The specific activity within the PVA clause related to the reconciliation. Select a PVA Activity from the picklist or select the Advanced Search 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 PVA Activity is assigned. Select a User from the picklist or select the Advanced Search icon to use filters and refine your search.
Due Date Enter the date on which the related PVA Activity is due for completion. Use the calendar to select the date or enter the date manually.
Completion Date Once the related PVA 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 Select the appropriate evaluation from the picklist, based on the PVA Activity's completion status.
Reason Enter any comments about the PVA Activity's completion. This field supports up to 5,000 characters.
### Agreement Documents Section {#agreement-documents} 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 _PV Agreement_. If your desired document does not appear in the search, select **Create** and complete the steps to upload a new document. When uploading PVA documents, use one of the following document types, 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_ Depending on your Admin's configuration, Vault can change the state of agreement documents to match the state of their linked _PV Agreement_. When a _PV Agreement_ moves to a steady or obsolete state type, Vault updates its linked documents to the same state, provided they meet the following conditions: * The document is linked to the initiating _PV Agreement_ via the _PV Agreement_ document field, which happens when: * You add a document to a _PV Agreement_ via its _Agreement Documents_ section * You create a document in your _Library_ and populate its _PV Agreement_ field with the initiating _PV Agreement_ record * The document's subtype is either: * _Pharmacovigilance Agreements > Agreement Documentation_ * _Pharmacovigilance Agreements > Master Agreement_ * To update the linked document to a steady state, the document is in the _Approved_ state #### Generate Draft PVA Documents {#generate-draft-pvas} Vault can generate a draft document with its format and contents defined by the [associated _PVA Outline_][29] and link it to the _Agreement Documents_ section. To generate a draft PVA document from a _PV Agreement_: 1. Navigate to **PVAs > PV Agreements > [PV Agreement]**. 2. From the **All Actions** menu, select **Generate Draft PVA**. Vault classifies this document as type _Pharmacovigilance Agreements > Agreement Documentation > PVA Core_ and sets its lifecycle state to _Draft_. Navigate to the document to begin collaborative authoring, view and annotate it in Vault, or checkout the document for editing outside of Vault. ### 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 {#pva-workflows} SafetyDocs supports the use of several workflows to keep track of the steps involved in _PV Agreement_ management. ### PVA Creation Workflow {#pva-creation-workflow} Use the PVA creation object workflow to author, review, and approve a _PV Agreement_ and its associated documents. You can initiate the PVA creation workflow from a _PV Agreement_ in the _Initiated_ state. Once started, the PVA creation workflow navigates through document workflows1 that allow you to: * Coordinate the drafting of the PVA * Review the PVA * Approve the PVA
Depending on your Admin's configuration, upon completing a PVA creation workflow, Vault updates the _PV Agreement_ to the _Pending Effective_ lifecycle state. Once the _PV Agreement_ reaches its [_Agreement Effective Date_][40], Vault updates the _PV Agreement_ and its related approved [documents][18] to the _Effective_ state. ### Inbound PVA Activity Workflow {#pva-activity-inbound} Use an inbound PVA activity workflow to verify the completion of an inbound [_PVA Activity_][41]. You can initiate an inbound PVA activity workflow from a _PVA Activity_ in the _New_ state. ### Outbound PVA Activity Workflow Use an outbound PVA activity workflow to complete an outbound [_PVA Activity_][41] and send it for approval. You can initiate an outbound PVA activity workflow from a _PVA Activity_ in the _New_ state. ### PVA Close Out Workflow When a _PV Agreement_ has reached the end of its term or otherwise needs to be terminated, use a PVA close out workflow to close it out. You can initiate a PVA close out workflow from a _PV Agreement_ in the _Effective_ state. [0]: #pva-scheduling [1]: #upload-pva-documents [2]: #create-a-pva-relationship [3]: #create-a-pv-agreement [4]: #action-items-section [5]: #obligations-section [6]: #activities-section [7]: #contacts-section [8]: #reconciliations-section [9]: #pva-workflows [10]: #obligations-section [11]: #schedule-pva-obligations [12]: #cancel-scheduled-obligations [13]: #update-obligation-dates [14]: #schedule-pva-obligations-for-pv-agreements [15]: #schedule-a-pva-obligation-from-a-pva-obligation-record [16]: #cancel-pva-obligations-from-a-pv-agreement-record [17]: #cancel-pva-obligations-from-a-pva-obligation-record [18]: #agreement-documents [19]: #update-obligation-dates-without-specified-days [20]: #update-obligation-dates-specified-days [21]: #cancel-scheduled-obligations [22]: #schedule-field [23]: #generate-draft-pvas [24]: #covered-product-families [25]: #covered-studies [26]: #covered-countries [27]: #pv-agreement-fields [28]: #contact-fields [29]: #pva-outline [30]: #pva-workflows [31]: #automated-intake [32]: #pva-creation-workflow [33]: #pva-obligation-fields [34]: #pva-activity-fields [36]: #pva-activity-inbound [37]: #automated-activity-creation [38]: #valid-obligation-category-values [39]: #activities-triggered-events [40]: #agreement-effective-date [41]: #activities-section