# 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_][1] to track the details of a request, such as its due date, related PSMF documents, and response plan. * [Add participants][3] to define the collaborators involved in completing the [PSMF request workflow][7] 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][10] to analyze PSMF request fulfillment timeliness. ## Prerequisite To use this feature, your Admin must enable PSMF Request Management. ## Create a PSMF Request {#create} To create a _PSMF Request_: 1. Navigate to the **PSMF Request** tab. 2. Select **Create**. 3. Populate the applicable [fields][2]. 4. Select **Save**. Upon saving the _PSMF Request_, the following sections may appear. Populate each according to your business processes: * [_Participants_][3] * [_PSMF Document(s) for Submission_][4] * [_Related PSMF Requests_][5] * [_Attachments_][6] ### PSMF Request Fields {#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 {#participants-section} Use the _Participants_ section on a _PSMF Request_ to add participants involved in [fulfilling the _PSMF Request_][7].

Note: When adding participants to a PSMF Request, ensure the selected Person is in the Active state and related to an active user.

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 {#documents-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.

Note: When the PSMF Request moves to the In PSMF Review state during a workflow, Vault creates a PSMF Document Review for each document in this section.

### Related PSMF Requests Section {#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][2]. ### Attachments Section {#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 {#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 ( Workflow Actions menu icon

), then select **Begin PSMF Request Workflow**. Upon starting the workflow, Vault assigns workflow tasks to all [participants][3] 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_][4] 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.

Note: As Vault creates only a single PSMF Periodic Review for each PSMF Request, running a PSMF Request workflow multiple times will not generate additional PSMF Periodic Reviews. If a PSMF Request requires more than one PSMF Periodic Review, create separate or related PSMF Requests.

## Run a PSMF Request Fulfillment Report {#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**. [1]: #create [2]: #fields [3]: #participants-section [4]: #documents-section [5]: #related-psmf-requests-section [6]: #attachments-section [7]: #workflow [8]: #requires-review [9]: #workflow-complete [10]: #fulfillment-report