# Enable PSMF Request Management

With the 26R2 release, SafetyDocs introduces <a href="/en/lr/1087971/">PSMF request management</a>, allowing PSMF users to handle PSMF inquiries from end to end in one central location.

## Prerequisites

Before enabling this feature in your Vault, we recommend <a href="/en/lr/01332/">enabling PSMF Periodic Reviews</a>. To support multiple reviewers on _PSMF Periodic Reviews_ created as a result of a _PSMF Request_, you must <a href="/en/lr/1006488/">enable Support Multiple Reviewers During PSMF Periodic Review</a>.

## Overview

To enable this feature in your Vault:

* <a href="/en/lr/4884/#use-shared-field">Assign</a> the _PSMF Request_ shared field to the _Pharmacovigilance System Master File_ document type
* [Update object layouts][1]
* [Configure security][2]
* [Create the _PSMF Request Workflow_][6]
* [Add actions to the _PSMF Request Lifecycle_][20]
* [Activate the _PSMF Request_ sub-tab][23]

## Update Object Layouts {#layouts}

To update the _PSMF Request_ and _PSMF Periodic Review_ <a href="/en/lr/26387/#how-to-access-page-layouts">object layouts</a>:

1. <a href="/en/lr/26387/#save-as-layout">Copy the standard layout</a> and ensure the new layout is active.
2. <a href="/en/lr/26387/#set-a-default-layout">Set the copied layout as the default</a>.
3. <a href="/en/lr/26387/#delete-a-layout">Delete</a> any other existing custom layouts.

To the updated _PSMF Request_ layout, <a href="/en/lr/26387/#how-to-add-sections">add</a> a related document section below the _Participants_ section as follows:

* **Referencing Document Field**: Select **PSMF Request**
* **Section Label**: Enter `PSMF Document(s) for Submission`
* **Criteria VQL**: Enter `type__v = 'Pharmacovigilance System Master File'`

## Configure Security {#security}

To configure security:

* <a href="/en/lr/36440/#how-to-add-roles">Add</a> the _PSMF Office_ role to the _PSMF Request Lifecycle_ object lifecycle
* [Edit role permissions][3] for the _PSMF Office_ role on the _PSMF Request Lifecycle_
* [Update the custom _PSMF Coordination Actions_ permission set][4]
* [Configure custom sharing rules for the _PSMF Request_ object][5]

### Edit Role Permissions for the PSMF Office Role {#role-permissions}

<a href="/en/lr/36440/#edit-role-lifecycle-state-permissions">Edit role permissions</a> for the _PSMF Office_ role on the _PSMF Request Lifecycle_ object lifecycle as follows:

<table>
  <thead>
    <tr>
      <th><strong>Lifecycle State</strong></th>
      <th><strong>Permissions</strong></th>
    </tr>
  </thead>
  <tbody>
    <tr>
      <td><em>New</em></td>
      <td>
        <ul>
          <li><em>Read</em></li>
          <li><em>Edit</em></li>
          <li><em>Delete</em></li>
        </ul>
      </td>
    </tr>
    <tr>
      <td><em>Cancelled</em></td>
      <td>
        <ul>
          <li><em>Read</em></li>
        </ul>
      </td>
    </tr>
    <tr>
      <td><em>Completed</em></td>
      <td>
        <ul>
          <li><em>Read</em></li>
        </ul>
      </td>
    </tr>
    <tr>
      <td><em>In PSMF Review</em></td>
      <td>
        <ul>
          <li><em>Read</em></li>
          <li><em>Edit</em></li>
        </ul>
      </td>
    </tr>
    <tr>
      <td><em>In Fulfillment</em></td>
      <td>
        <ul>
          <li><em>Read</em></li>
          <li><em>Edit</em></li>
        </ul>
      </td>
    </tr>
  </tbody>
</table>

### Update the Custom PSMF Coordination Actions Permission Set {#permission-set}

To update the custom _PSMF Coordination Actions_ permission set, add <a href="/en/lr/22824/#objectpermissions">object permissions</a> as follows:

* To the _PSMF Request_ object, add _Read_, _Create_, and _Edit_ permissions
* To the _PSMF Request - Person_ object, add _Read_, _Create_, _Edit_, and _Delete_ permissions

### Configure Custom Sharing Rules for the PSMF Request Object {#custom-sharing-rules}

To configure custom sharing rules for the _PSMF Request_ object:

1. <a href="/en/lr/25494/#configuration-overview">Enable custom sharing rules</a> for the _PSMF Request_ object.
2. <a href="/en/lr/25494/#how-to-create-sharing-rules">Create a custom sharing rule</a> labeled `PSMF Office - PSMF Requests` and in the _Roles_ panel, add a manual assignment as follows:
    * **Role**: Select **PSMF Office**
    * **Users & Groups**: Select **PSMF Coordination**

## Create the PSMF Request Workflow {#workflow}

To create the _PSMF Request Workflow_:

1. <a href="/en/lr/33550/#create">Create an object workflow</a>, populating fields as follows:
    * **Label**: Enter `PSMF Request Workflow`
    * **Lifecycle**: Select **PSMF Request Lifecycle**
2. Configure the following workflow steps:
    * [_Start_][7]
    * [_Task: PSMF Review Required?_][8]
    * [_Decision: PSMF Review?_][9]
    * [_SC: Cancelled_][10]
    * [_SC: In Fulfillment_][11]
    * [_Action: Set Date Sent Field_][12]
    * [_Task: Send for Fulfillment_][13]
    * [_Decision: Complete Request?_][14]
    * [_SC: Completed_][15]
    * [_SC: In PSMF Review_][16]
    * [_Task: PSMF Review Outcome_][17]
    * [_Decision: Move to Fulfillment?_][18]
    * [_SC: New_][19]
3. <a href="/en/lr/33550/#activate">Activate the workflow</a>.

<a href="https://platform.veevavault.help/assets/images/safetydocs-psmf-request-workflow.png" data-lightbox="safetydocs-psmf-request-workflow.png" data-title="" data-alt="PSMF Request Workflow">
  <img class="docimage" src="https://platform.veevavault.help/assets/images/safetydocs-psmf-request-workflow.png" alt="PSMF Request Workflow" style="max-width: 100%;width: 300px;"  />
</a>

### Configure the Start Step {#start-step}

To configure the <a href="/en/lr/33550/#start">_Start_ step</a>:

1. Add a control as follows:
    * **Control 1**: Select **Participants**
        * **Participant Label**: Enter `PSMF Request Participants`
        * **Add Participants**: Select **Use custom action to define participants**
            * **Custom Action**: Select **Assign PSMF Request Workflow Participants**
2. In the **Next Steps** field:
    * Remove the **End** step
    * Select **Create Step**
    * In the _Create Step_ dialog, enter `Task: PSMF Review Required?` in the **Step Name** field

### Configure the Task: PSMF Review Required? Step {#task-psmf-review-required-step}

To define the _Task: PSMF Review Required?_ <a href="/en/lr/33550/#wftaskstep">task step</a>:

1. In the _General Settings_ section, populate fields as follows:
    * **Task Label**: Enter `PSMF Review Required?`
    * **Assign Task To**: Select **PSMF Request Participants**
        * Select **Assign to all users in participant group**
    * **Instructions**: Enter `Determine if this PSMF Request requires a PSMF Ad Hoc Review.`
    * **Task Requirement**: Select **Required**
2. In the _Prompts_ section, select the **Prompt for Verdicts** checkbox, then populate fields as follows:
    * **Verdict Label**: Enter `PSMF Review Required`
    * Select **Add Verdict**
    * **Verdict Label**: Enter `PSMF Review Not Required`
    * Select **Add Verdict**
    * **Verdict Label**: Enter `Cancel Request`
        * Select **Add Comments**, then in the **Prompt for Comments** field, enter `Cancel request details` and select the **Required** checkbox
3. In the _Details_ section, for **Next Steps**, select **Create Step**, then enter `Decision: PSMF Review?` in the  **Step Name** field.

### Configure the Decision: PSMF Review? Step {#decision-psmf-review-step}

To define the _Decision: PSMF Review?_ <a href="/en/lr/33550/#decision">decision step</a>:

1. Select **Create Rule** then populate the fields as follows:
    * **Condition Type**: Select **All conditions are met**
        * **If**: Select **Task** > **Task: PSMF Review Required?** > **all labels equal** > **PSMF Review Required**
            * **then**: Select **Create Step**
                * In the _Create Step_ dialog, enter `SC: In PSMF Review` in the **Step Name** field.
2. Select **Create Rule**.
3. In the _Else Rule 2_ section, populate fields as follows:
    * **Condition Type**: Select **All conditions are met**
        * **If**: Select **Task** > **Task: PSMF Review Required?** > **all labels equal** > **PSMF Review Not Required**
            * **then**: Select **Create Step**
                * In the _Create Step_ dialog, enter `SC: In Fulfillment` in the **Step Name** field.
4. Select **Create Rule**.
5. In the _Else Rule 3_ section, populate fields as follows:
    * **Condition Type**: Select **All conditions are met**
        * **If**: Select **Task** > **Task: PSMF Review Required?** > **all labels equal** > **Cancel Request**
            * **then**: Select **Create Step**
                * In the _Create Step_ dialog, enter `SC: Cancelled` in the **Step Name** field.
6. In the **then** field of the _Else_ section, select **Create Step**.
    * In the _Create Step_ dialog, enter `SC: New` in the **Step Name** field.

### Configure the SC: Cancelled Action Step {#sc-cancelled-step}

To define the _SC: Cancelled_ <a href="/en/lr/33550/#how-to-define-an-action-step">action step</a>:

1. <a href="/en/lr/33550/#how-to-define-conditions">Create a rule</a> as follows:
    * **Condition Type**: Select **Always**
        * **perform actions**: Select **Change State**
            * **Lifecycle State**: Select **Cancelled**
2. For **Next Steps** select **End**.

### Configure the SC: In Fulfillment Action Step {#sc-in-fulfillment-step}

To define the _SC: In Fulfillment_ <a href="/en/lr/33550/#how-to-define-an-action-step">action step</a>:

1. <a href="/en/lr/33550/#how-to-define-conditions">Create a rule</a> as follows:
    * **Condition Type**: Select **Always**
        * **perform actions**: Select **Change State**
            * **Lifecycle State**: Select **In Fulfillment**
2. For **Next Steps** select **Create Step**, then enter `Action: Set Date Sent Field` in the **Step Name** field.

### Configure the Action: Set Date Sent Field Step {#action-set-date-sent-field-step}

To define the _Action: Set Date Sent Field_ <a href="/en/lr/33550/#how-to-define-an-action-step">action step</a>:

1. <a href="/en/lr/33550/#how-to-define-conditions">Create a rule</a> as follows:
    * **Condition Type**: Select **Always**
        * **perform actions**: Select **Update field**
            * **Fields**: Select **Date Sent for Fulfillment/Submission**
            * **Set to value**: Enter `Today()`
2. For **Next Steps** select **Create Step**, then enter `Task: Send for Fulfillment` in the **Step Name** field.

### Configure the Task: Send for Fulfillment Step {#task-send-for-fulfillment-step}

To define the _Task: Send for Fulfillment_ <a href="/en/lr/33550/#wftaskstep">task step</a>:

1. In the _General Settings_ section, populate fields as follows:
    * **Task Label**: Enter `Send for Fulfillment`
    * **Assign Task To**: Select **PSMF Request Participants**
        * Select **Assign to all users in participant group**
    * **Instructions**: Enter `Send PSMF document(s) to relevant Requester(s). Once sent, please enter the Request Completion Date, upload evidence of submission/receipt, and click the Complete button.`
    * **Task Requirement**: Select **Required**
2. In the _Prompts_ section, select the **Prompt for Verdicts** checkbox, then populate fields as follows:
    * **Verdict Label**: Enter `Complete`
    * Select **Add Verdict**
    * **Verdict Label**: Enter `Cancel Request`
3. In the _Details_ section, for **Next Steps**, select **Create Step**, then enter `Decision: Complete Request?` In the **Step Name** field.

### Configure the Decision: Complete Request? Step {#decision-complete-request-step}

To define the _Decision: Complete Request?_ <a href="/en/lr/33550/#decision">decision step</a>, create rules as follows:

1. Select **Create Rule** then populate the fields as follows:
    * **Condition Type**: Select **All conditions are met**
        * **If**: Select **Task** > **Task: Send for Fulfillment** > **all labels equal** >  **Complete**
            * **then**: Select **Create Step**
                * In the _Create Step_ dialog, enter `SC: Completed` in the **Step Name** field.
2. Select **Create Rule**.
3. In the _Else Rule 2_ section, populate fields as follows:
    * **Condition Type**: Select **All conditions are met**
        * **If**: Select **Task** > **Task: Send for Fulfillment** > **all labels equal** >  **Cancel Request**
            * **then**: Select **SC: Cancelled**
4. In the _Else_ section, select **SC: New** for the **then** field.

### Configure the SC: Completed Action Step {#sc-completed-step}

To define the _SC: Completed_ <a href="/en/lr/33550/#how-to-define-an-action-step">action step</a>:

1. <a href="/en/lr/33550/#how-to-define-conditions">Create a rule</a> as follows:
    * **Condition Type**: Select **Always**
        * **perform actions**: Select **Change State**
            * **Lifecycle State**: Select **Completed**
    * Select **Add Action**
    * Select **Update field**
        * **Fields**: Select **Request Completion Date**
        * **Set to Value**: Enter `today()`
2. For **Next Steps**, select **End**.

### Configure the SC: In PSMF Review Action Step {#sc-in-psmf-review-step}

To define the _SC: In PSMF Review_ <a href="/en/lr/33550/#how-to-define-an-action-step">action step</a>:

1. <a href="/en/lr/33550/#how-to-define-conditions">Create a rule</a> as follows:
    * **Condition Type**: Select **Always**
        * **perform actions**: Select **Change State**
            * **Lifecycle State**: Select **In PSMF Review**
2. For **Next Steps** select **Create Step**, then enter `Task: PSMF Review Outcome` in the **Step Name** field.

### Configure the Task: PSMF Review Outcome Step {#task-psmf-review-outcome-step}

To define the _Task: PSMF Review Outcome_ <a href="/en/lr/33550/#wftaskstep">task step</a>:

1. In the _General Settings_ section, populate fields as follows:
    * **Task Label**: Enter `PSMF Review Outcome`
    * **Assign Task To**: Select **PSMF Request Participants**
        * Select **Assign to all users in participant group**
    * **Instructions**: Enter `Detail the outcome of the PSMF Review and determine if the request is ready to be fulfilled.`
    * **Task Requirement**: Select **Required**
2. In the _Prompts_ section, configure prompts as follows:
    * Select the **Prompt for Fields** checkbox, then populate fields as follows:
        * **Fields**: Select **PSMF Changes Required**
            * Select the **Required** checkbox
    * Select the **Prompt for Verdicts** checkbox, then populate fields as follows:
        * **Verdict Label**: Enter `Move to Fulfillment`
        * Select **Add Verdict**
        * **Verdict Label**: Enter `Cancel Request`
3. In the _Details_ section, for **Next Steps**, select **Create Step**, then enter `Decision: Move to Fulfillment?` in the **Step Name** field.

### Configure the Decision: Move to Fulfillment? Step {#decision-move-to-fulfillment-step}

To define the _Decision: Move to Fulfillment?_ <a href="/en/lr/33550/#decision">decision step</a>:

1. Select **Create Rule** then populate the fields as follows:
    * **Condition Type**: Select **All conditions are met**
        * **If**: Select **Task** > **Task: PSMF Review Outcome** > **all labels equal** > **Move to Fulfillment**
            * **then**: Select **SC: In Fulfillment**
2. Select **Create Rule**.
3. In the _Else Rule 2_ section, populate fields as follows:
    * **Condition Type**: Select **All conditions are met**
        * **If**: Select **Task** > **Task: PSMF Review Outcome** > **all labels equal** > **Cancel Request**
            * **then**: Select **SC: Cancelled**
4. In the _Else_ section, select **SC: New** for the then field.

### Configure the SC: New Action Step {#sc-new-step}

To define the _SC: New_ <a href="/en/lr/33550/#how-to-define-an-action-step">action step</a>:

1. <a href="/en/lr/33550/#how-to-define-conditions">Create a rule</a> as follows:
    * **Condition Type**: Select **Always**
        * **perform actions**: Select **Change State**
            * **Lifecycle State**: Select **New**
2. For **Next Steps**, select **End**.

## Add Actions to the PSMF Request Lifecycle {#add-actions}

To support the _PSMF Request Workflow_, add the following actions to the _PSMF Request Lifecycle_ <a href="/en/lr/30683/">object lifecycle</a>:

* [Add a user action to the _New_ state][21]
* [Add an entry action to the _In PSMF Review_ state][22]

### Add a User Action to the New State {#user-action-new-state}

<a href="/en/lr/59885/#define-actions">Add a user action</a> to the _New_ state of the _PSMF Request Lifecycle_ as follows:

* **Condition Type**: Select **Always**
* **Allow the following actions**: Select **Workflow**
    * Select **PSMF Request Workflow**
    * **Action Label**: Enter `Begin PSMF Request Workflow`

### Add an Entry Action to the In PSMF Review State {#entry-action-in-psmf-review-state}

<a href="/en/lr/59885/#define-entry-action">Add an entry action</a> to the _In PSMF Review_ state of the _PSMF Request Lifecycle_ as follows:

* **Condition Type**: Select **Always**
* **perform actions**: Select **Create Ad Hoc PSMF Review**

## Activate the PSMF Request Sub-Tab {#activate-sub-tab}

To <a href="/en/lr/23516/#access-control">activate</a> the _PSMF Request_ sub-tab, navigate to the **PSMF** tab collection, select the **PSMF Request** tab, and set the **Status** to **Active**.

[1]: #layouts
[2]: #security
[3]: #role-permissions
[4]: #permission-set
[5]: #custom-sharing-rules
[6]: #workflow
[7]: #start-step
[8]: #task-psmf-review-required-step
[9]: #decision-psmf-review-step
[10]: #sc-cancelled-step
[11]: #sc-in-fulfillment-step
[12]: #action-set-date-sent-field-step
[13]: #task-send-for-fulfillment-step
[14]: #decision-complete-request-step
[15]: #sc-completed-step
[16]: #sc-in-psmf-review-step
[17]: #task-psmf-review-outcome-step
[18]: #decision-move-to-fulfillment-step
[19]: #sc-new-step
[20]: #add-actions
[21]: #user-action-new-state
[22]: #entry-action-in-psmf-review-state
[23]: #activate-sub-tab