**Source URL:** https://safety.veevavault.help/en/gr/1113395/

# 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 enable PVA Periodic Review.

## 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 _Pharmacovigilance Agreements_ document type
    * 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.

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. Upload the document to your _Library_.
2. Classify it using a relevant _Pharmacovigilance Agreements_ document type, 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].

**Note**: When a document enters the _Effective_ state:

* If a _PVA Periodic Review_ already exists for the document with the same _PVA Last Review Date_, Vault does not create another _PVA Periodic Review_.
* If the first _PVA Periodic Review_ would be due for review today or earlier, Vault does not create the _PVA Periodic Review_. To capture an ad-hoc PVA review, create a manual review.

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

The following fields may be available:

<table>
  <thead>
    <tr>
      <th>Field
      <th>Description

<tbody>
    <tr>
      <td>PV Agreement
      <td markdown="span">Select the PV Agreement related to the document from the picklist or select the Advanced Search (Binoculars Icon) icon to use filters and refine your search.
    
    <tr>
      <td>PVA Last Review Date
      <td>
        Manually enter the date the document was last reviewed, or use the calendar to select the date. Vault uses this value1, in addition to the PVA Schedule and PVA Review Timeline (Days) values, to determine when to start creating PVA Periodic Reviews for the document.
        When a PVA Periodic Review task is completed for the document with a Review Outcome of No changes needed, Vault populates the current date.

<tr>
      <td>PVA Next Review Due Date
      <td>
        Manually enter the date the document should be reviewed next, or use the calendar to select the date.
        When a document is captured for review by the Safety Scheduler Job, or when a PVA Periodic Review is completed with a Review Outcome of No changes needed, Vault populates this field by calculating the PVA Last Review Date plus the amount of time dictated by the PVA Schedule, minus the PVA Review Timeline (Days) value.
        Vault clears this field when the document's periodic reviews are canceled.

<tr>
      <td>PVA Review Timeline (Days)
      <td>Enter the number of days any resulting PVA Periodic Reviews should take to complete.
    
    <tr>
      <td>PVA Schedule
      <td markdown="span">Select a Schedule to define the schedule that any resulting PVA Periodic Reviews should follow.
    
    <tr>
      <td colspan="2">
        1. If the PVA Last Review Date is blank, Vault determines the document's last review date using the following priority order, then populates the selected value for the PVA Last Review Date:
        
          The Agreement Effective Date on the PV Agreement related to the document
          If the Agreement Effective Date is blank, Vault uses today's date

## 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:

| Field | Description |
| --- | --- |
| _PV Agreement_ | Select the _PV Agreement_ containing the document to review. For _PVA Periodic Reviews_ scheduled by Vault, Vault populates the _PV Agreement_ from the initiating document. |
| _Document to Review_ | Select the documents to review from the picklist or select the **Advanced Search** (Binoculars Icon) icon to use filters and refine your search. For _PVA Periodic Reviews_ scheduled by Vault, Vault populates the document that initiated the periodic review. |
| _Version_ | 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. |
| _Assigned To_ | Select the user to whom the review task should be assigned. For _PVA Periodic Reviews_ scheduled by Vault, Vault populates the _Agreement Owner_ from the related _PV Agreement_. |
| _Due Date_ | Enter the date by which this document should be reviewed and approved, or use the calendar to select the date.

For _PVA Periodic Reviews_ scheduled by Vault, Vault populates the date the _PVA Periodic Review_ is created plus the number of days specified by the document's _PVA Review Timeline (Days)_ value. |
| _Review Type_ | Select _Periodic_ or _Ad-Hoc_. For _PVA Periodic Reviews_ scheduled by Vault, Vault populates _Periodic_. |
| _Review Outcome_ | Once the document has been reviewed, select the appropriate outcome. |
| _Review Rationale_ | Once the document has been reviewed, enter any additional details explaining the review outcome. |

## 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_ task.
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. Update the lifecycle state 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 workflows 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 state type, 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