Manage PSMF Requests

SafetyDocs supports PSMF request management, allowing you to handle the end-to-end flow of tracking and responding to PSMF-related inquiries from health authorities, partners, and more. With this feature, you can:

• Create a PSMF Request to track the details of a request, such as its due date, related PSMF documents, and response plan.
• Add participants to define the collaborators involved in completing the PSMF request workflow to respond to the PSMF inquiry. As part of the workflow, Vault can generate an ad-hoc PSMF Periodic Review to manage any necessary PSMF updates.
• Run reports to analyze PSMF request fulfillment timeliness.

Prerequisite

To use this feature, your Admin must enable PSMF Request Management.

Create a PSMF Request

To create a PSMF Request:

1. Navigate to the PSMF Request tab.
2. Select Create.
3. Populate the applicable fields.
4. Select Save.

Upon saving the PSMF Request, the following sections may appear. Populate each according to your business processes:

• Participants
• PSMF Document(s) for Submission
• Related PSMF Requests
• Attachments

PSMF Request Fields

The following fields may be available:

Field	Description
Request Description	Enter a description for the PSMF request. Vault uses this value when searching for related PSMF Requests.
Request Type	Select a request type from the picklist.
PSMF Jurisdiction	Select the Country of the PSMF request jurisdiction.
Requester	Select the agency or partner Organization for which you are completing the PSMF request.
Date of Request	Use the calendar to select the date the PSMF request was received, or enter the date manually.
Due Date	Use the calendar to select the due date for the PSMF request, or enter the date manually.
Current PSMF Document	Select the Pharmacovigilance System Master File-type document to which this PSMF request relates, or select the Advanced Search () icon to use filters and refine your search.
Version	Vault populates the latest version of the document to be reviewed. To change this selection, select a different version from the picklist.
Request Comments	Enter any comments related to the PSMF request.
Primary PSMF Request	Select the primary PSMF Request to which this request relates. For example, if this PSMF Request pertains to a specific EMA jurisdiction, its Primary PSMF Request might pertain to the main EMA request.
PSMF Review	Vault populates the ad-hoc PSMF Periodic Review that is created when the request enters the In PSMF Review state.
PSMF Review Status	Vault populates the lifecycle state of the related PSMF Periodic Review.
Response Plan	Select a value from the picklist to define the planned response you will take to address this PSMF request.
Response Plan Details	Enter any details related to your response plan.
PSMF Changes Required	Select values from the picklist to define the changes required for this PSMF request.
Date Sent for Fulfillment/Submission	When all participants have indicated the workflow is complete and the request has been sent for fulfillment, Vault populates today's date. Alternatively, once the request is sent, you can use the calendar to select the date the PSMF request was submitted or sent for fulfillment, or enter the date manually.
Request Completion Date	When the request enters the Completed state, Vault populates today's date. Alternatively, once the request is complete, use the calendar to select the date the PSMF request was completed, or enter the date manually.

Participants Section

Use the Participants section on a PSMF Request to add participants involved in fulfilling the PSMF Request.

To add PSMF Request participants:

1. Select Add.
2. In the Search: Person window:
   • To add existing Persons:
     1. Optional: Enter a search term in the search bar, then select the Search () icon.
     2. Optional: Apply filters.
     3. Select the checkbox next to the Person.
   • To create a new Person:
     1. Select Create.
     2. In the Create Person dialog, select Base Person.
     3. In the Create Person window, populate fields, then select Save.
3. Once you have added all participants, select OK.
4. Optional: Select values for each participant’s PSMF Request Role as needed.

PSMF Document(s) for Submission Section

To add documents to the PSMF Request, select Add, then use the Search: Documents window to search for Pharmacovigilance System Master File-type documents as needed.

Related PSMF Requests Section

Use the Related PSMF Requests section on a PSMF Request to create other related PSMF Requests. To create a related PSMF Request, select Create, then populate the applicable fields.

Attachments Section

Use the Attachments section on a PSMF Request to upload relevant attachments related to the request, such as PDFs of the PSMF request correspondence.

Complete a PSMF Request Workflow

The PSMF Request workflow guides you through the end-to-end process for assessing and fulfilling a PSMF request, from determining whether the request requires an ad-hoc PSMF review to authoring any relevant PSMF changes to fulfilling and completing the request.

To initiate a workflow from a PSMF Request, select the Workflow Actions menu (), then select Begin PSMF Request Workflow. Upon starting the workflow, Vault assigns workflow tasks to all participants defined on the PSMF Request, tasking each participant with indicating whether the request requires an ad-hoc PSMF review.

If all participants indicate that the request requires a review, Vault:

• Moves the PSMF Request to the In PSMF Review state
• Creates a PSMF Periodic Review and populates its fields
• Populates the PSMF Periodic Review with a PSMF Document Review for each document defined in the PSMF Document(s) for Submission section on the PSMF Request

Each participant is responsible for completing their assigned PSMF Document Reviews, then indicating the review outcome on the PSMF Request to determine whether to cancel the request or prepare and send it for fulfillment.

Once the PSMF Request has been satisfied, participants indicate completion of the workflow. If all participants indicate that the request has been completed and/or sent for fulfillment, Vault populates the Date Sent for Fulfillment/Submission value and moves the PSMF Request to the Completed state.

Run a PSMF Request Fulfillment Report

The PSMF Request Fulfillment report provides insight on your organization’s operational efficiency around fulfilling PSMF requests, categorizing request participants’ PSMF Request performance by submission timeliness. You can filter report results by PSMF Jurisdiction, Date of Request, and PSMF Request lifecycle state, allowing you to answer questions about open requests, late requests, and more.

To run a PSMF Request Fulfillment report:

1. Navigate to Analytics > Reports.
2. Select the standard PSMF Request Fulfillment report.
3. Optional: Apply filters as needed.
4. Select Continue.