# Configure PVA Outlines

You can create _PVA Outlines_ to generate draft pharmacovigilance agreement (PVA) documents for a _PV Agreement_, allowing your users to produce standardized PVAs for different use cases without the additional time and effort associated with manual PVA drafting. _PVA Outlines_ are composed of _PVA Outline Clauses_ that define the clause wording and order in the overall outline. You can further define _PVA Outline Subclauses_ within a _PVA Outline Clause_ for added granularity, each with their own wording and order. 

Each _PVA Outline_'s associated _Word Formatted Output Template_ defines the structure and format of the PVA documents Vault generates when users run the <a href="/en/lr/01242/#generate-draft-pvas">_Generate Draft PVA_ action</a> on the associated _PV Agreement_, as well as which elements of the _PVA Outline_ appear in the generated document. 

## Prerequisite

To use this feature, your Admin must <a href="/en/lr/927203/">enable Generate Draft Pharmacovigilance Agreement Documents</a>.

## Create a PVA Outline {#create-pva-outline}

To create a _PVA Outline_:
1. Navigate to **PVAs > PVA Outlines**.
2. Select **Create**.
3. In the _Create PVA Outline_ dialog, complete the applicable [fields][2].
4. Select **Save**.

After you save the _PVA Outline_, a [_PVA Outline Clauses_][3] section appears. 

### PVA Outline Fields {#pva-outline-fields}

The following fields may be available:

<table>
  <thead>
    <tr>
      <th>Field</th>
      <th>Description</th>
    </tr>
  </thead>
  <tbody>
    <tr>
      <td><em>Name</em></td>
      <td>Enter a name.</td>
    </tr>
    <tr>
      <td><em>Description</em></td>
      <td>Enter a description.</td>
    </tr>
    <tr>
      <td><em>PV Agreement</em></td>
      <td>Select the <a href="/en/lr/01242/#create-a-pv-agreement"><em>PV Agreement</em></a> to which this outline applies. Once complete, you must also set the <a href="/en/lr/01242/#pva-outline"><em>PVA Outline</em> field on the <em>PV Agreement</em></a> to link to this <em>PVA Outline</em>.</td>
    </tr>
    <tr>
      <td><em>Scope</em></td>
      <td>Vault populates this field with the <em>PVA Scope</em> value from the associated <em>PV Agreement</em>.</td>
    </tr>
    <tr>
      <td><em>PV Agreement Type</em></td>
      <td>Vault populates this field with the <em>PV Agreement Type</em> value from the associated <em>PV Agreement</em>.</td>
    </tr>
    <tr>
      <td><em>Word Formatted Output Template</em></td>
      <td>Select a <a href="/en/lr/796234/"><em>Word Formatted Output Template</em></a>. Vault uses this template to generate a Word document containing the <em>PVA Outline Clauses</em> and <em>PVA Outline Subclauses</em> defined in the <em>PVA Outline</em>.</td>
    </tr>
  </tbody>
</table>

## Add a PVA Outline Clause {#add-pva-outline-clause}

To create a _PVA Outline Clause_:
1. Navigate to the _PVA Outline_ for which you want to define a clause and expand the **PVA Outline Clauses** section.
2. Select **Create**.
3. In the _Create PVA Outline Clause_ dialog, complete the applicable [fields][4].
4. Select **Save**.

If applicable, you can navigate to the _PVA Outline Clause_ to add [_PVA Outline Subclauses_][5]. 

### PVA Outline Clause Fields {#pva-outline-clause-fields}

The following fields may be available:

<table>
  <thead>
    <tr>
      <th>Field</th>
      <th>Description</th>
    </tr>
  </thead>
  <tbody>
    <tr>
      <td><em>Name</em></td>
      <td>Enter a name for the <em>PVA Outline Clause</em>.</td>
    </tr>
    <tr>
      <td><em>Order in Outline</em></td>
      <td>Enter a number to define the order in which this clause appears in the overall <em>PVA Outline</em> and generated PVA documents.</td>
    </tr>
    <tr>
      <td><em>Clause Title</em></td>
      <td>Enter a clause title. Depending on your Admin's configuration, Vault may use this value to define the title of the clause in generated PVA documents.</td>
    </tr>
    <tr>
      <td><em>Clause Wording</em></td>
      <td>Enter the clause wording. Depending on your Admin's configuration, Vault may use this value to define the body text of the clause in generated PVA documents</td>
    </tr>
    <tr>
      <td><em>Task Instructions</em></td>
      <td>Enter any task instructions required to meet the obligation.</td>
    </tr>
    <tr>
      <td><em>Obligation Category</em></td>
      <td>Select a category.</td>
    </tr>
  </tbody>
</table>

## Add a PVA Outline Subclause {#add-pva-outline-subclause}

To create a _PVA Outline Subclause_:
1. Navigate to the _PVA Outline Clause_ for which you want to define a subclause and expand the **PVA Outline Subclauses** section.
2. Select **Create**.
3. In the _Create PVA Outline Subclause_ dialog, complete the applicable [fields][6].
4. Select **Save**.

### PVA Outline Subclause Fields {#pva-outline-subclause-fields}

The following fields may be available:

<table>
  <thead>
    <tr>
      <th>Field</th>
      <th>Description</th>
    </tr>
  </thead>
  <tbody>
    <tr>
      <td><em>PVA Outline Clause</em></td>
      <td>Vault populates this field with the parent <em>PVA Outline Clause</em>.</td>
    </tr>
    <tr>
      <td><em>Order in Outline</em></td>
      <td>Enter a number to define the order in which this subclause appears in the overall <em>PVA Outline Clause</em> and generated PVA documents.</td>
    </tr>
    <tr>
      <td><em>Clause Title</em></td>
      <td>Enter a clause title. Depending on your Admin's configuration, Vault may use this value to define the title of the subclause in generated PVA documents.</td>
    </tr>
    <tr>
      <td><em>Clause Wording</em></td>
      <td>Enter the subclause wording. Depending on your Admin's configuration, Vault may use this value to define the body text of the subclause in generated PVA documents.</td>
    </tr>
    <tr>
      <td><em>Task Instructions</em></td>
      <td>Enter any task instructions required to meet the obligation.</td>
    </tr>
    <tr>
      <td><em>Obligation Category</em></td>
      <td>Select a category.</td>
    </tr>
  </tbody>
</table>

[1]: #create-pva-outline
[2]: #pva-outline-fields
[3]: #add-pva-outline-clause
[4]: #pva-outline-clause-fields
[5]: #add-pva-outline-subclause
[6]: #pva-outline-subclause-fields