Enable PSMF Request Management

With the 26R2 release, SafetyDocs introduces PSMF request management, 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 enabling PSMF Periodic Reviews. To support multiple reviewers on PSMF Periodic Reviews created as a result of a PSMF Request, you must enable Support Multiple Reviewers During PSMF Periodic Review.

Overview

To enable this feature in your Vault:

• Assign the PSMF Request shared field to the Pharmacovigilance System Master File document type
• Update object layouts
• Configure security
• Create the PSMF Request Workflow
• Add actions to the PSMF Request Lifecycle
• Activate the PSMF Request sub-tab

Update Object Layouts

To update the PSMF Request and PSMF Periodic Review object layouts:

1. Copy the standard layout and ensure the new layout is active.
2. Set the copied layout as the default.
3. Delete any other existing custom layouts.

To the updated PSMF Request layout, add 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

To configure security:

• Add the PSMF Office role to the PSMF Request Lifecycle object lifecycle
• Edit role permissions for the PSMF Office role on the PSMF Request Lifecycle
• Update the custom PSMF Coordination Actions permission set
• Configure custom sharing rules for the PSMF Request object

Edit Role Permissions for the PSMF Office Role

Edit role permissions for the PSMF Office role on the PSMF Request Lifecycle object lifecycle as follows:

Lifecycle State	Permissions
New	Read Edit Delete
Cancelled	Read
Completed	Read
In PSMF Review	Read Edit
In Fulfillment	Read Edit

Update the Custom PSMF Coordination Actions Permission Set

To update the custom PSMF Coordination Actions permission set, add object permissions 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

To configure custom sharing rules for the PSMF Request object:

1. Enable custom sharing rules for the PSMF Request object.
2. Create a custom sharing rule 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

To create the PSMF Request Workflow:

1. Create an object workflow, populating fields as follows:
   • Label: Enter PSMF Request Workflow
   • Lifecycle: Select PSMF Request Lifecycle
2. Configure the following workflow steps:
   • Start
   • Task: PSMF Review Required?
   • Decision: PSMF Review?
   • SC: Cancelled
   • SC: In Fulfillment
   • Action: Set Date Sent Field
   • Task: Send for Fulfillment
   • Decision: Complete Request?
   • SC: Completed
   • SC: In PSMF Review
   • Task: PSMF Review Outcome
   • Decision: Move to Fulfillment?
   • SC: New
3. Activate the workflow.

Configure the Start Step

To configure the Start step:

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

To define the Task: PSMF Review Required? task step:

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

To define the Decision: PSMF Review? decision step:

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

To define the SC: Cancelled action step:

1. Create a rule 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

To define the SC: In Fulfillment action step:

1. Create a rule 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

To define the Action: Set Date Sent Field action step:

1. Create a rule 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

To define the Task: Send for Fulfillment task step:

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

To define the Decision: Complete Request? decision step, 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

To define the SC: Completed action step:

1. Create a rule 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

To define the SC: In PSMF Review action step:

1. Create a rule 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

To define the Task: PSMF Review Outcome task step:

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

To define the Decision: Move to Fulfillment? decision step:

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

To define the SC: New action step:

1. Create a rule 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

To support the PSMF Request Workflow, add the following actions to the PSMF Request Lifecycle object lifecycle:

• Add a user action to the New state
• Add an entry action to the In PSMF Review state

Add a User Action to the New State

Add a user action 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

Add an entry action 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

To activate the PSMF Request sub-tab, navigate to the PSMF tab collection, select the PSMF Request tab, and set the Status to Active.