**Source URL:** https://safety.veevavault.help/en/lr/1113395/index.md

# Manage PVA Periodic Reviews

SafetyDocs supports automatically scheduling reviews of _Pharmacovigilance Agreements_ documents to ensure they are regularly updated, providing an efficient way of ensuring that your PVAs are always compliant and up-to-date.

## Prerequisite

To use PVA periodic reviews, your Admin must <a href="/en/lr/1102665/">enable PVA Periodic Review</a>.

## PVA Periodic Review Process {#process}

Each day when the _Safety Scheduler Job_ runs, Vault:

1. Detects documents that are due for review based on the following criteria:
    * The document is classified under a relevant <a href="/en/lr/01242/#upload-documents">_Pharmacovigilance Agreements_ document type</a>
    * The document is in the _Effective_ state
    * The document's [PVA field values][4] indicate that the document requires a review
2. Creates a [_PVA Periodic Review_][6] for each document that is due for review.
3. For each _PVA Periodic Review_, sends a notification and assigns a review task to the [appropriate reviewer][8].

The assigned users then [complete their reviews][11] for the associated documents, updating content as required and selecting an appropriate review outcome.

<a id ="example"></a>For example, consider an approved PVA document with a _PVA Last Review Date_ of May 11, 2025, an annual _PVA Schedule_, and a _PVA Review Timeline (Days)_ of 10 days. As this document's next review is due on May 11, 2026, its review must start on May 1, 2026. As such, when the _Safety Scheduler Job_ runs on May 1, 2026, it detects this document as due for review, creates a _PVA Periodic Review_ for the document, and assigns a review task to its reviewer.

## Include PVA Documents in Periodic Reviews {#include-documents}

To include a PVA document in periodic reviews:

1. <a href="/en/lr/15085/">Upload the document to your _Library_</a>.
2. Classify it using a relevant <a href="/en/lr/01242/#upload-documents">_Pharmacovigilance Agreements_ document type</a>, as determined by your Admin's configuration.
3. Populate the applicable [fields][4].
 
When the document enters the _Effective_ state, Vault begins considering it for periodic reviews. Once the document's field values indicate that it is [due for review][2], Vault creates a _PVA Periodic Review_ and populates its [fields][7].

 <div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: When a document enters the <em>Effective</em> state:</p>

<ul>
  <li>If a <em>PVA Periodic Review</em> already exists for the document with the same <em>PVA Last Review Date</em>, Vault does not create another <em>PVA Periodic Review</em>.</li>
  <li>If the first <em>PVA Periodic Review</em> would be due for review today or earlier, Vault does not create the <em>PVA Periodic Review</em>. To capture an ad-hoc PVA review, <a href="/en/lr/1113395/#create-pva-periodic-review">create a manual review</a>.</li>
</ul>
    </div>
  </div>
</div>



### PVA Document Fields {#pva-document-fields}

The following fields may be available:

<table>
  <thead>
    <tr>
      <th>Field</th>
      <th>Description</th>
    </tr>
  </thead>
  <tbody>
    <tr>
      <td><em>PV Agreement</em></td>
      <td>Select the <a href="/en/lr/01242/#create-a-pv-agreement"><em>PV Agreement</em></a> related to the document from the picklist or select the <strong>Advanced Search</strong> (<img class="inline" src="https://platform.veevavault.help/assets/images/icon-binoculars.png" alt="Binoculars Icon" style="" />) icon to use filters and refine your search.</td>
    </tr>
    <tr>
      <td><em>PVA Last Review Date</em></td>
      <td>
        <p>Manually enter the date the document was last reviewed, or use the calendar to select the date. Vault uses this value<sup><a href ='#last-review-date'>1</a></sup>, in addition to the <em>PVA Schedule</em> and <em>PVA Review Timeline (Days)</em> values, to determine when to start creating <em>PVA Periodic Reviews</em> for the document.</p>
        <p>When a <a href="/en/lr/1113395/#review-document"><em>PVA Periodic Review</em> task</a> is completed for the document with a <em>Review Outcome</em> of <a href="/en/lr/1113395/#no-changes-needed"><em>No changes needed</em></a>, Vault populates the current date.</p>
      </td>
    </tr>
    <tr>
      <td><em><a id ='pva-next-review-due-date'></a>PVA Next Review Due Date</em></td>
      <td>
        <p>Manually enter the date the document should be reviewed next, or use the calendar to select the date.</p>
        <p>When a document is <a href="/en/lr/1113395/#process">captured for review by the <em>Safety Scheduler Job</em></a>, or when a <em>PVA Periodic Review</em> is completed with a <em>Review Outcome</em> of <em>No changes needed</em>, Vault populates this field by calculating the <em>PVA Last Review Date</em> plus the amount of time dictated by the <em>PVA Schedule</em>, minus the <em>PVA Review Timeline (Days)</em> value.</p>
        <p>Vault clears this field when the <a href="/en/lr/1113395/#cancel-scheduled-reviews">document's periodic reviews are canceled</a>.</p>
      </td>
    </tr>
    <tr>
      <td><em>PVA Review Timeline (Days)</em></td>
      <td>Enter the number of days any resulting <em>PVA Periodic Reviews</em> should take to complete.</td>
    </tr>
    <tr>
      <td><em>PVA Schedule</em></td>
      <td>Select a <a href="/en/lr/827001/"><em>Schedule</em></a> to define the schedule that any resulting <em>PVA Periodic Reviews</em> should follow.</td>
    </tr>
    <tr>
      <td colspan="2">
        <p><a id ='last-review-date'></a>1. If the <em>PVA Last Review Date</em> is blank, Vault determines the document's last review date using the following priority order, then populates the selected value for the <em>PVA Last Review Date</em>:</p>
        <ol>
          <li>The <em>Agreement Effective Date</em> on the <em>PV Agreement</em> related to the document</li>
          <li>If the <em>Agreement Effective Date</em> is blank, Vault uses today's date</li>
        </ol>
      </td>
    </tr>
  </tbody>
</table>

## Create a PVA Periodic Review {#create-pva-periodic-review}

While [the _Safety Scheduler Job_ automatically creates _PVA Periodic Reviews_ for qualifying documents][1], if needed, you can manually create an ad-hoc review outside of the scheduled job.

To manually create a _PVA Periodic Review_:

1. Navigate to **PVA > Periodic Reviews**.
2. Select **Create**.
3. Complete the applicable [fields][7], then select **Save**.

Once complete, Vault sends a notification and assigns a [review task][11] to the user identified in the [_Assigned To_ field][8].

### PVA Periodic Review Fields {#pva-periodic-review-fields}

The following fields may be available:

<table>
  <thead>
    <tr>
      <th>Field</th>
      <th>Description</th>
    </tr>
  </thead>
  <tbody>
    <tr>
      <td><em>PV Agreement</em></td>
      <td>Select the <a href="/en/lr/01242/#create-a-pv-agreement"><em>PV Agreement</em></a> containing the document to review. For <a href="/en/lr/1113395/#process"><em>PVA Periodic Reviews</em> scheduled by Vault</a>, Vault populates the <em>PV Agreement</em> from the initiating document.</td>
    </tr>
    <tr>
      <td><em>Document to Review</em></td>
      <td>Select the <a href="/en/lr/01242/#agreement-documents">document</a> to review from the picklist or select the <strong>Advanced Search</strong> (<img class="inline" src="https://platform.veevavault.help/assets/images/icon-binoculars.png" alt="Binoculars Icon" style="" />) icon to use filters and refine your search. For <em>PVA Periodic Reviews</em> scheduled by Vault, Vault populates the document that initiated the periodic review.</td>
    </tr>
    <tr>
      <td><em>Version</em></td>
      <td>Vault populates the latest steady state version of the document to be reviewed. To change the populated value, select a different version from the picklist.</td>
    </tr>
    <tr>
      <td><em><a id ='assigned-to'></a>Assigned To</em></td>
      <td>Select the user to whom the review task should be assigned. For <em>PVA Periodic Reviews</em> scheduled by Vault, Vault populates the <em>Agreement Owner</em> from the related <em>PV Agreement</em>.</td>
    </tr>
    <tr>
      <td><em><a id ='due-date'></a>Due Date</em></td>
      <td>
        <p>Enter the date by which this document should be reviewed and approved, or use the calendar to select the date.</p>
        <p>For <em>PVA Periodic Reviews</em> scheduled by Vault, Vault populates the date the <em>PVA Periodic Review</em> is created plus the number of days specified by the document's <em>PVA Review Timeline (Days)</em> value.</p>
      </td>
    </tr>
    <tr>
      <td><em>Review Type</em></td>
      <td>Select <em>Periodic</em> or <em>Ad-Hoc</em>. For <em>PVA Periodic Reviews</em> scheduled by Vault, Vault populates <em>Periodic</em>.</td>
    </tr>
    <tr>
      <td><em>Review Outcome</em></td>
      <td>Once the document has been <a href="/en/lr/1113395/#review-document">reviewed</a>, select the appropriate outcome.</td>
    </tr>
    <tr>
      <td><em>Review Rationale</em></td>
      <td>Once the document has been reviewed, enter any additional details explaining the review outcome.</td>
    </tr>
  </tbody>
</table>

## Cancel Scheduled Periodic Reviews {#cancel-scheduled-reviews}

If required, you can cancel any future periodic reviews for a document by moving the document to the _Terminated_ state. Once the document is terminated, Vault clears its _PVA Next Review Due Date_ and the _Safety Scheduler Job_ does not create any future _PVA Periodic Reviews_ for the document.

## Review a PVA Document {#review-document}

When a [_PVA Periodic Review_][6] is created, Vault assigns it to the selected reviewer as a task so they can review and approve it.

To complete a _PVA Periodic Review_:

1. Navigate to the _PVA Periodic Review_ <a href="/en/lr/40751/#viewing-user-tasks">task</a>.
2. Select the **Document to Review** to open the document and review its contents. Once complete, navigate back to the _PVA Periodic Review_.
3. Select **Edit**.
4. Expand the **Review** section and select the relevant _Review Outcome_. Add any comments in the **Review Rationale** field as needed.
5. Select **Save**. 
6. <a href="/en/lr/70436/#using-lifecycles">Update the lifecycle state</a> of the _PVA Periodic Review_ to **Complete**.

Depending on the selected outcome, Vault completes a series of object record and document updates:

* [_No changes needed_][12]
* [_Minor changes needed_ or _Major changes needed_][13]
* [_Unable to review_][14]

### No Changes Needed {#no-changes-needed}

When a reviewer selects a _Review Outcome_ of _No changes needed_ and moves the _PVA Periodic Review_ to the _Complete_ state, Vault: 

* Updates the document's _PVA Last Review Date_ to the current date
* Updates the document's [_PVA Next Review Due Date_][5] to the _PVA Last Review Date_ plus the amount of time dictated by the _PVA Schedule_, minus the _PVA Review Timeline (Days)_ value
* Continues to [schedule _PVA Periodic Reviews_][1] for the document

### Minor Changes Needed or Major Changes Needed {#changes-needed}

When a reviewer selects a _Review Outcome_ of _Minor changes needed_ or _Major changes needed_ and moves the _PVA Periodic Review_ to the _Complete_ state, Vault creates a new minor version of the document so that changes can be drafted.

You can use the PVA authoring, review, and approval <a href="/en/lr/01242/#pva-workflows">workflows</a> to make the necessary changes required to update your PVA document. Once the changes have been made to the new minor version and the document enters a steady <a href="/en/lr/14560/#state-types">state type</a>, Vault begins to [schedule _PVA Periodic Reviews_][1] for the new major document version.

### Unable to Review {#unable-to-review}

When a reviewer selects a _Review Outcome_ of _Unable to review_ and moves the _PVA Periodic Review_ to the _Complete_ state, Vault takes no action. The next time Vault [schedules _PVA Periodic Reviews_][1], Vault includes the related document for review.

[1]: #process
[2]: #example
[3]: #include-documents
[4]: #pva-document-fields
[5]: #pva-next-review-due-date
[6]: #create-pva-periodic-review
[7]: #pva-periodic-review-fields
[8]: #assigned-to
[9]: #due-date
[10]: #cancel-scheduled-reviews
[11]: #review-document
[12]: #no-changes-needed
[13]: #changes-needed
[14]: #unable-to-review