Using Oversight Plans & Schedules

In Clinical Operations Vaults, you can define, automate, and document recurring Study oversight activities using Oversight Plans and Oversight Schedule Items. This helps study teams execute oversight according to an approved Oversight Plan, capture findings, attach evidence, and maintain audit-ready records for regulatory inspections.

This functionality is available in all CTMS and eTMF Vaults, but may require configuration by your Admin prior to utilization.

  • Oversight Plan: A study-level record that defines the overall oversight strategy for a study. Only one Oversight Plan can be in the Approved state for a study at a given time.
  • Oversight Schedule Item: A recurring activity defined within an Oversight Plan. It specifies what activity to perform, the execution frequency, the responsible role, and the scope (Study, Study Country, or Study Site).
  • Oversight Task: A system-generated or ad-hoc task record assigned to a user for execution and evidence capture.
  • Oversight Issue: A user-logged finding created in the context of an Oversight Task to document and track specific findings identified during oversight activities.

Creating an Oversight Plan

  1. Navigate to the Study Info > Studies tab and select a Study.
  2. In the Setup section, select Oversight Plans.
  3. Click Create.
  4. Enter a Name for the Oversight Plan.
  5. Click Save.

Creating Oversight Schedule Items

Within an Oversight Plan, add individual schedule items to establish recurring tasks:

  1. Open an existing Oversight Plan.
  2. In the Oversight Schedule Items section, click Create.
  3. Enter a Name and Task Description.
  4. Enter the Frequency (Days) to specify how often Vault will create the task.
  5. Select a Responsible Role (such as Study Manager or CRA).
  6. Optional: Select an Initiating Milestone to activate the schedule item automatically upon milestone completion, or an Ending Milestone to stop task generation.
  7. Optional: Set an Initial Offset (days after the record entering the Active state before the first task is generated) and a Due Date Offset (days allowed to complete each generated task).
  8. Click Save.

Manually Start or End an Oversight Schedule Item

If an Oversight Schedule Item does not have an Initiating Milestone defined, you can activate it manually. Open the desired Oversight Schedule Item and select Start Oversight Schedule Item from the All Actions menu. Vault sets the Item Status to Active and calculates the next task creation date.

To manually stop recurrence for an active item select End Oversight Schedule Item from the All Actions menu. Vault sets the Item Status to Ended and stops future task generation.

Executing Oversight Tasks

Vault automatically generates Oversight Task records on the defined schedule using a daily system job. You must have an Application Role that matches the Oversight Schedule Item Responsible Role, and be assigned the relevant role in the Oversight Task Sharing Settings to accept and complete Oversight Tasks.

Accepting and Completing an Oversight Task

  1. Navigate to the Home tab and select All Tasks or Available Tasks.
  2. Locate the assigned Oversight Task and click Continue.
  3. In the task header banner, click Accept. Vault updates the task lifecycle state to In Progress and populates you as the Assigned To user. The Oversight Task is now unable to be accepted by another user.
  4. Review the Task Description and conduct the required review activities.
  5. Optional: In the Oversight Issues section, click Create to log any identified findings.
  6. Optional: In the Attachments section, click Upload to attach supporting documentation or evidence.
  7. Click Complete in the task header banner.
  8. In the prompt dialog, enter the Completion Date and provide a Comment.
  9. Click Complete. This moves the Oversight Task to the Complete lifecycle state.

Creating an Ad-Hoc Oversight Task

You can also log one-off, unplanned oversight activities outside of the standard schedule:

  1. Navigate to the relevant Study record.
  2. In the Oversight Tasks section, click Create.
  3. Enter a Name and Task Description.
  4. Click Save.
  5. Manually populate the Assigned To field and complete the task using the standard workflow steps.

How to Cancel an Oversight Task

If a planned task is no longer required:

  1. Open an Oversight Task in the Planned state.
  2. Select Cancel Task from the Actions menu.
  3. Enter a Cancellation Reason.
  4. Click Complete.

You can complete all steps in this article with the standard Business Admin, 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 Objects: Oversight Plan: Create, Edit Ability to create and edit Oversight Plans.
Security Profile Objects: Oversight Schedule Item: Create, Edit Ability to create, edit, and trigger actions on Oversight Schedule Items.
Security Profile Objects: Oversight Task: Create, Edit Ability to create ad-hoc tasks, accept, complete, and cancel Oversight Tasks.
Security Profile Objects: Oversight Issue: Create, Edit Ability to create and link Oversight Issues to Oversight Tasks.