You are here

Clinical trial notification (CTN) form - user guide

V1.2, August 2020

21 August 2020

Book pagination

Submitting a completion advice

To submit a completion advice to us, you will need to access the Clinical Trials Repository.

The two options below can be used to access the Clinical Trials Repository.

Option 1

Access the dashboard as described in How to login.

Select Work on drafts or View Submissions under the My work menu on the dashboard.

screenshot showing Work on drafts or View Submissions options on the My work menu

The online Portal menu will be displayed on the left hand side. Follow the steps in Option 2 below to access the Clinical Trials Repository.

Option 2

  • If you are already working within the online Portal menu, select Portal at the top of the menu.
  • Select Your TGA Information.
  • Select Clinical Trials Repository.
screenshot showing Clinical Trials Repository link in the portal menu
  • You will then see a list of processed CTNs in the Clinical Trials Repository.
  • Select the drop-down arrow beside the CTN you wish to complete (located at the far left of each CTN - it will turn green when selected), then select Complete.
screenshot showing Complete option

After selecting Complete, a web page message will appear. Select OK to proceed.

A screenshot of dialog box: Are you sure you want to complete this trial?

The CTN you wish to complete will then open as a draft.

  • Select the Completion tab and enter the following details:
Field name Information required
Name* Name will auto-populate.
Contact Phone Number* Contact phone number will auto-populate.
Contact Email* Contact email address will auto-populate.
Date Trial Completed* Enter the date the trial was completed at all Australian sites in the format dd/mm/yyyy or select from the pop-up calendar.
Completion Reason* Select the reason for trial closure from the drop-down list.

Book pagination