Regulatory Management: Change Log and Audit Trail

Overview

This document outlines the steps to view information in the Change Log (audit trail) of Reviewer Checklists.

Navigation

Role: Committee Member > Home Workspace > Review Workspace

Step-by-Step Process

1. Click the Change Log for Submission activity.
   Note This will open a one page change log of all the changes.
   

Alternatively, follow the steps below to view the saved changes made for each page.

1. Click Path>> (in the upper-left corner), then click the link to the left of the Review name in the breadcrumb trail.
   
2. If the submission is an Amendment (AME), click Amendment Audit Trail.
   
   OR
   If the submission is a new application (HUM), Continuing Review (SCR), or Adverse Event/ORIO (ADV), click the Change Tracking tab.
   
3. Each row of the Change Tracking table (or Amend Application Change Log for AMEs) lists changes saved on a particular page. Click on the applicable Change Log: Page # link.
4. The Activity Details page displays the following information:
   • The Author is the person who made the change to and saved the application.
   • The Activity Date represents the date and time the change was made.
   • The Property Changes tab displays the Property, Old Value and New Value that was changed when the page was saved.

5. Click <Prev and Next> to navigate through the various changes.
6. Click Return to Workspace (or Return to Amendment Workspace) when you’ve finished viewing the Change Log.