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
Each day when the Safety Scheduler Job runs, Vault:
- 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 indicate that the document requires a review
- Creates a PVA Periodic Review for each document that is due for review.
- For each PVA Periodic Review, sends a notification and assigns a review task to the appropriate reviewer.
The assigned users then complete their reviews 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
To include a PVA document in periodic reviews:
- Upload the document to your Library.
- Classify it using a relevant Pharmacovigilance Agreements document type, as determined by your Admin’s configuration.
- Populate the applicable fields.
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, Vault creates a PVA Periodic Review and populates its fields.
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
The following fields may be available:
| Field | Description |
|---|---|
| PV Agreement | Select the PV Agreement related to the document from the picklist or select the Advanced Search ( ) icon to use filters and refine your search. |
| PVA Last Review Date |
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. |
| PVA Next Review Due Date |
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. |
| PVA Review Timeline (Days) | Enter the number of days any resulting PVA Periodic Reviews should take to complete. |
| PVA Schedule | Select a Schedule to define the schedule that any resulting PVA Periodic Reviews should follow. |
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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:
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Create a PVA Periodic Review
While the Safety Scheduler Job automatically creates PVA Periodic Reviews for qualifying documents, if needed, you can manually create an ad-hoc review outside of the scheduled job.
To manually create a PVA Periodic Review:
- Navigate to PVA > Periodic Reviews.
- Select Create.
- Complete the applicable fields, then select Save.
Once complete, Vault sends a notification and assigns a review task to the user identified in the Assigned To field.
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 document to review from the picklist or select the Advanced Search () 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
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
When a PVA Periodic Review 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:
- Navigate to the PVA Periodic Review task.
- Select the Document to Review to open the document and review its contents. Once complete, navigate back to the PVA Periodic Review.
- Select Edit.
- Expand the Review section and select the relevant Review Outcome. Add any comments in the Review Rationale field as needed.
- Select Save.
- 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
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 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 for the document
Minor Changes Needed or Major 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 for the new major document version.
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, Vault includes the related document for review.