How to Regulatory Review a Document with Attachments

Once the regulatory reviewer receives an email stating about a pending review, they log into TI to locate the documents waiting for review in the Regulatory Review section.

Steps to Regulatory Review a Document

  1. The easiest way to find all the documents in the Study Start-Up waiting for regulatory review is to activate the By Regulatory Approval Status view from the left panel, which lists out all the documents in the SSU pending approval.

  2. Select the checkbox of the file that displays Pending status.

  3. Click the Document View button displayed at the bottom of the grid pane. The document opens in the grid pane.

  4. Click the Approve/Reject button displayed in the top menu bar. This opens the document in the ‘Document Preview’ popup window.

  5. Verify if the contents in the selected document are appropriate.

  6. Click the Reject or Approve button displayed at the bottom of the popup window.

  7. If the Reject button is selected, the ‘Reject Document’ popup window is displayed.

  8. Enter a rejection reason in the empty field. (Mandatory).

  9. Click the Reject Document button displayed at the bottom of the popup window.

  10. If the Approve button is selected, the Approve Document popup window is displayed, asking if the document is to be approved.
  11. Click the Approve Document button displayed at the bottom of the popup window.

Depending upon the decision taken, a message will pop up indicating that the change is now committed to the database. The document is now locked and cannot be opened for review again. The Regulatory Approval Status of the documents throughout the SSU will now reflect the appropriate status from Pending to Approved or Rejected. The Document button at the bottom of the dashboard and the Approve or Reject buttons are now disabled to prevent further changes.