Sponsor Review

A new notification is introduced for Sponsor Reviewers, similar to the existing Regulatory Reviewer notification. When documents are submitted for Sponsor Oversight, notifications are sent only to users with the Sponsor role. However, actions such as approve or reject can be performed by any authorized user, not limited to Sponsor users.

Basic settings

  1. In the SSU Room Settings, ensure Enable Sponsor Review is selected under Sites > Study Start-Up.
  2. Under Email > Notification Preferences, enable the following options:
    • Notify when a document is submitted by the Start-Up Sponsor Reviewer
    • Notify when a document is approved by the Start-Up Sponsor Reviewer
    • Notify when a document is rejected by the Start-Up Sponsor Reviewer
  3. As User 1, confirm the Site is ready for activation with all required documents completed.
  4. Ensure at least two documents are approved by User 1 (Essential Approval Status and Regulatory Approval Status) and submitted for Sponsor Review.

Follow the steps below:

  1. Click on the Site name that is ready for Activation.
  2. Click the Documents option on the left side of the index panel on the Site Details page.
  3. Select the documents in the grid.
  4. Click on the Submit to Sponsor Review button. The 'Pending' status is displayed in the new column Sponsor Approval Status for the document submitted for Sponsor Review.
  5. As a Sponsor Reviewer, click the Sponsor Review icon on the left side of the screen.
  6. The Sponsor Review page is displayed with 'Site Activation' at the top and View By Sponsor Approval Status in the index pane, including the Pending and Approved folders.
  7. Select the document and click the Approve/Reject button.
  8. Click Approve. The 'Document is Approved' notification message is displayed on the top right of the screen.