Configuring Oversight Plans & Schedules

In Clinical Operations Vaults, Oversight Plan and Schedule Items enable study teams to define recurring sponsor oversight activities, auto-generate tasks on cadence, and track evidence capture.

Vault includes standard objects and fields to support oversight functionality:

Oversight Plan (oversight_plan__v): Study-level container record.
Oversight Schedule Item (oversight_schedule_item__v): Tracks recurring activity definitions, frequency, offset parameters, and job schedules.
Oversight Task (oversight_task__v): System-generated or ad-hoc task instances executed by end users.
Oversight Task – Oversight Issue (oversight_task_oversight_issue__v): Join object linking tasks to Oversight Issues.
Oversight Task – Issue (oversight_task_issue__v): Join object linking tasks to standard Vault issues.

Note: This feature is only available in Clinical Operations Vaults (CTMS and eTMF).

Configuration Overview

Oversight Planning & Schedule requires configuration before users can access and execute oversight workflows:

Add related object sections for the Oversight Plan and Oversight Task objects to the Study object’s page layout.
Configure object lifecycles and user actions.
Configure the standard approval workflow.
Assign application roles and update permission sets.

Configuring Oversight Planning & Schedule Lifecycles

Configure user actions on object lifecycles to allow users to transition records manually when necessary.

Oversight Schedule Item Lifecycle

Navigate to Admin > Configuration > Object Lifecycles > Oversight Schedule Item Lifecycle.
On the Active state, add the Start Oversight Schedule Item user action with criteria enforcing that Item Status is Standby.
On the Active state, add the End Oversight Schedule Item user action with criteria enforcing that Item Status is Active.

Oversight Task Lifecycle

Navigate to Admin > Configuration > Object Lifecycles > Oversight Task Lifecycle.
On the Planned state, add a Cancel Oversight Task user action. Ensure the action prompts for a required cancellation comment, updates the lifecycle state to Cancelled, and sends the Oversight Task Cancelled notification to Vault Owners.

Configuring Oversight Object Workflows

To utilize oversight planning you must configure workflows for Oversight Plan approval and Oversight Task assignment.

Configuring Oversight Plan Approval Workflows

Configure an approval object workflow for the Oversight Plan Lifecycle to manage version control and the Approved Date:

Navigate to Admin > Configuration > Workflows.
Create or edit an approval workflow for the Oversight Plan Lifecycle.
On the transition to the Approved state, add Action Steps to:
- Set Approved Date = Today().
- Increment the Version field.
Activate the workflow and create a Workflow type User Action on the Draft state of the Oversight Plan Lifecycle.

Note: Vault automatically enforces that only one Oversight Plan can be in the Approved state per Study at any time. If a user attempts to approve a second plan for a study, Vault displays an error message.

Understanding Oversight Task Assignment

Vault includes an Oversight Schedule Job that runs daily to automate task assignment.

The job executes the following operations:

Evaluates all active Oversight Schedule Items under Approved Oversight Plans.
Checks if milestone conditions have been met to transition items from Standby to Active.
Generate new Oversight Task records for active items where Next Create Date <= Today().
Sets Opened Date = Today() and Due Date = Today() + Due Date Offset.
Advances Next Create Date on the schedule item to Today() + Frequency (Days).

If task generation fails for any item, Vault sends an Oversight Schedule Job Completed with Errors notification with an attached error CSV file to Vault Owners.

Note: Ad-hoc Oversight Tasks are excluded from this job.

Configuring Access

Update desired Permission Sets to ensure intended users (such as Study Managers or CRAs) have object permissions to view, create, and edit Oversight Plans, Oversight Schedule Items, Oversight Tasks, and Oversight Task - Issues.

Note: When the daily system job generates an Oversight Task, it evaluates the Responsible Role defined on the parent Schedule Item and automatically assigns the workflow to users holding that role for the specific Study, Country, or Site. If no users match the role, the workflow defaults to the Vault Owner role.

You can complete all steps in this article with the System Admin or Vault Owner profile.

If your Vault uses custom security profiles, your profile must grant the following permissions:

Type	Permission Label	Controls
Security Profile	Admin: Configuration: Objects: Edit	Ability to configure object page layouts, fields, and relationships.
Security Profile	Admin: Configuration: Object Lifecycles: Edit	Ability to configure lifecycles, states, atomic security, and user actions.
Security Profile	Admin: Configuration: Workflows: Edit	Ability to create and edit object workflows.