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Clinical trial notification (CTN) form - user guide

V1.2, August 2020

21 August 2020

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How to check the status of your CTN

View lodged submissions

The two options below can be used to view lodged submissions.

Option 1

  • Access the dashboard as described in How to login.
  • Select View Submissions under the My work menu on the dashboard.
screenshot showing View submissions option on the My work menu

Option 2

  • If you are already working within the online Portal menu, select Portal at the top of the menu.
  • Select View Lodged Submissions.

A list of Submissions will be displayed.

screenshot showing the Submissions page

The status of your submitted CTN will be displayed in the Workflow Status column.

  • Submitted: This means that you have submitted your CTN but payment has not been received or the TGA has not yet started processing your submission.
  • Under Review: The TGA is processing your submission.
  • Withdrawn: Your CTN has been withdrawn by the TGA.
  • Pending Write to Repository: Your CTN is in the process of updating to your Clinical Trials Repository.

If you have submitted a notification and you need to make changes before it is processed, see Editing a submitted form or a push back.

During processing we review the CTN form to ensure data is entered correctly. If any corrections are required, the CTN form will be returned to you for editing. See Editing a submitted form or a push back for more information.

View the Clinical Trials Repository

When the TGA has processed your CTN and no further corrections are required, it will move from the Submissions list to 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

If your CTN appears in the Clinical Trials Repository, then it has been processed by the TGA.

screenshot showing Clinical Trials Repository

The status of your acknowledged CTN is displayed in the Stage column.

  • Trial Details: This is a new CTN.
  • Completion: This is a completed CTN.
  • Variation: This is a variation to an existing CTN.

Refer to the section Print a TGA acknowledgement for details on printing a TGA acknowledgement from the Clinical Trials Repository.

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