Editing a Package

  1. Click on the package name the Package Details page is displayed.

  2. Click on the Edit button displayed on the top menu bar. The Package Name field gets editable on the General Information page with the Save and Cancel buttons.

  3. Make the changes in the required fields and click the Save button displayed on the top menu bar.
  4. Click the Cancel button to discard the changes.

Change Status

The user can change the status of a country by following the steps below:

  1. Click the Change Status button displayed on the Package Details page. This opens the Change Status pop-up window.
  2. Select the appropriate status from the dropdown menu of the Status field.
  3. Select the Status Date by clicking the Calendar icon. Mention comments if required in the box below.
  4. Click the Save button at the bottom of the pop-up window.

  5. The notification message is displayed as ‘Status Changed’.

Status History

A Status History button is displayed below the Change Status button. Click the button to view the name of the user who made the changes on the IRB/EC Details page.

Note: The user can only view the history and cannot edit any information in the table displayed.

Documents

  1. Select the document that is added to the selected package and click the Download Package button.

  2. The package is downloaded notification message is displayed on the top right of the screen.

  3. Click on the Get Results button on the notification message. The zip file of the selected package is downloaded.

Sites

  1. Select the associated site of the selected package and click the Approval Received button on the top menu bar.

  2. The Approval Received for Site (s) pop-up window is displayed with the Cancel and Confirm Received Approval buttons.

  3. Click the Confirm Received Approval button to confirm the approval. The IRB/EC Approval Letter column displays the Approval Received status for the selected site.
  4. Click the Cancel button to discard the changes.

  5. Locate the Site and click the Reject button on the top menu bar. The Reject Sites (s) pop-up window is displayed with the Cancel and Reject buttons.

  6. Click the Reject button once the user enter the Rejection Reason in the box.
  7. Click the Cancel button to discard the changes.

  8. Locate the site and click the Remove button on the top menu bar. The Remove Site (s) pop-up window is displayed with the No and Remove buttons.

  9. Click the Remove button the selected site gets removed from the grid.

Change Log

A Change Log is a file that records all notable changes made to a package. It helps users understand what has changed in different versions of the package.