You are here

Clinical trial notification (CTN) form - user guide

V1.2, August 2020

21 August 2020

Book pagination

Varying trial details

To vary or make changes to a CTN that has been processed by the TGA 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 option 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 the 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 want to vary (located at the far left of each CTN - it will turn green when selected), then select Vary.
Screenshot showing Vary option
  • After selecting Vary, a web page message will appear. Select OK to proceed.
screenshot showing dialog box: Are you sure you want to vary this trial?

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

To make changes to the CTN:

  • You can make changes to any of the fields displayed in the tab or add new details as required. The information required in each field is the same as described under the Trial details tab.
screenshot showing Change to Trial details tab in the CTN form
  • You will need to save and validate the CTN form and then submit the CTN form to us. Refer to the Validation and Submitting sections.
  • Certain changes to an existing CTN incur a fee. See Paying for your CTN for more information.
  • See How to check the status of your CTN for information on checking the status of your CTN.
  • Once the CTN form has been submitted and payed for, we will review the CTN to ensure data has been entered correctly.

Error messages

If the submission is currently being processed by us you will not be able to vary the trial and the following message will appear. You will need to wait until we have processed the previous submission for you to make a variation.

screenshot of error message: A variation submission is being processed. You should find it in 'View Lodged Submissions'

If a draft submission already exists for the CTN, then you will receive the error message below. You will need to find the existing draft in View Drafts.

screenshot of error message: A draft submission already exists. You should find it in 'View Drafts'

Book pagination