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Clinical trial notification (CTN) form - user guide
V1.2, August 2020
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.
Access the dashboard as described in How to login.
Select Work on drafts or View Submissions under the My work menu on the dashboard.
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.
- 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.
- 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.
- After selecting Vary, a web page message will appear. Select OK to proceed.
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.
- 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.
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.
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.