Enable PVA: Event Based Activities

With the 26R1 release, SafetyDocs automates the creation of activities for monitored obligation events. This feature allows users to create PVA Obligations to monitor for specific PSMF, RMP, or signal events. When a monitored event is detected, Vault creates a series of object records to support addressing the event.

After you have enabled this feature, see the following articles for more information:

Prerequisites

To enable this feature, you must first enable:

Depending on the events for which you want to permit automated event creation, you must first enable:

Overview

To enable this feature:

Update Object Layouts and Fields

Update the following objects:

Update the PV Agreement Layout

To update the PV Agreement layout, add the following fields to the bottom of the Details section:

  • Marketing Authorization Holder
  • Global Safety Database Holder

Update the PVA Multi-Agreement Activity Object

To update the PVA Multi-Agreement Activity layout:

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

Then, update the Due Date field as follows:

  1. Navigate to Admin > Configuration > Objects > PVA Multi-Agreement Activity > Fields > Due Date.
  2. Select Edit.
  3. Update the following values:
    • Label: Enter Default Activity Due Date
    • Help Content: Enter Select the default calendar date that will be used as related Activity Due Dates. Vault applies this date only when the PVA Obligation's Timeline is not specified in days.
  4. Select Save.

Update the PVA Obligation Object

To update the PVA Obligation layout:

  1. Copy the standard layout and ensure it is active.
  2. Set the copied layout as the default.
  3. Delete any other existing custom layouts.
  4. Update the new layout as follows:
    • Add the Activities Triggered by Events? field below the ICSR Type field
    • Update the Timeline Days layout rule. In the Apply the following display effects section, add the following new display effect:
      • Effect: Select Display as Required
      • Type: Select Fields
      • Values: Select Timeline Days

Then, update the Obligation Direction field as follows:

  1. Navigate to Admin > Configuration > Objects > PVA Obligation > Fields > Obligation Direction.
  2. Select Edit.
  3. Update the following values:
    • Help Content: Enter Defines whether activities are sent to, received from, or both with a partner. Vault calculates the default value based on the PV Agreement's MAH and GSDH values, and the Obligation's Responsible Party field.
    • In the Default Value section, select the Default based on expression checkbox, then enter the following default value expression: If( Or( responsible_party__v = 'company__v', And( responsible_party__v = 'global_safety_database_holder__v', pv_agreement__vr.pva_gsdh__v = 'company__v' ), And( responsible_party__v = 'marketing_authorization_holder__v', pv_agreement__vr.pva_mah__v = 'company__v' ) ), Picklist.pva_distribution_type__v.outbound__v, If( Or( responsible_party__v = 'partner__v', And( responsible_party__v = 'global_safety_database_holder__v', pv_agreement__vr.pva_gsdh__v = 'partner__v' ), And( responsible_party__v = 'marketing_authorization_holder__v', pv_agreement__vr.pva_mah__v = 'partner__v' ) ), Picklist.pva_distribution_type__v.inbound__v, If( Or( responsible_party__v = 'both_parties_separately__v', responsible_party__v = 'both_parties_jointly__v' ), Picklist.pva_distribution_type__v.both__v, null ) ) )
  4. Select Save.

Update Lifecycles

Configure the following entry actions on the relevant document and object lifecycles as required by your business processes:

  • To allow monitoring of RMP events, create a document lifecycle entry action on the Approved state of the General Document Lifecycle with the following settings:
    • Condition Type: Select All conditions are met
    • If: Select Classification > equals > Risk Management > Risk Management Plan > Core RMP
    • perform actions: Select Trigger PVA Event Activity
  • To allow monitoring of PSMF events, create a document lifecycle entry action on the Final state of the PSMF Generated Document Lifecycle with the following settings:
    • Condition Type: Select All conditions are met
    • If: Select Classification > equals > Pharmacovigilance System Master File > PSMF Generated Document > PSMF Generated PDF
    • perform actions: Select Trigger PVA Event Activity
  • To allow monitoring of signal events, create an object lifecycle entry action on the Risk Mitigation state of the Safety Investigation Lifecycle with the following settings:
    • Condition Type: Select Always
    • perform actions: Select Trigger PVA Signal Event Activity