Watch this video to learn more about creating and submitting a Clinical Trial Notification (CTN) using the online form.
Transcript
Show transcript of this video
To log into your online portal, follow these steps.
In your Browser, open the TGA website and select Login to TGA Business Services on the top right of the page.
Enter your user ID and password.
Please note you must be listed as a drafter on the TGA eBusiness account to input and edit information or hold submitter status to input, edit and submit notifications and declarations to the TGA.
Once logged in, you will see a personalised work page or 'dashboard'. What you can see and do on the dashboard will depend on what user role you have been given. More information can be found at TGA Business services - how to use the site.
Across the top of the TGA Business Portal dashboard there are three main menus: Applications; Documents; and Your TGA.
There are 2 ways to create a new CTN form:
- Within the dashboard select Clinical Trial Notification from the Applications pull down menu at the top of the page. The first page of the online form will open directly.
- If you have submitted a Clinical Trial Notification before, you can select Work on drafts from the My work menu. Your online portal will open.
This is your online portal. Depending on your TBS role you may be able to view draft notifications, view submitted notifications, draft a new notification, submit a notification and view your Repository.
To create a new notification, click on Clinical Trial Notification under the Clinical Trials tab of your online portal menu. This will open a new Clinical Trial Notification or CTN form.
Begin entering details in the form, starting with the Application tab. Select Sponsor Name and Address from the drop down menu.
Under the Trial details tab, fill out all of the requested information. Please note, areas marked with red asterisks are mandatory.
Under This Trial, select all options that apply to your trial. When selected, most check boxes will open a new sub-section to the form. You will need to fill out each individual sub-form that opens.
You will also need to complete trial site details.
You can save a draft notification at any time by selecting Save at the top left of the form. We recommend that you save the application at regular intervals. The status of the form will change to Draft Saved.
You can edit your drafts at any time prior to submitting them.
To edit a saved draft, select Work on drafts under the My work section on the dashboard screen. You can also select View drafts from your online portal menu.
A valid notification must include a therapeutic good: a medicine, device or biological.
Once all information has been entered, save the form and click on Validate. You will be taken to the Validation messages tab. This will show any errors that need to be corrected prior to submission.
If there is an error, click on the error and amend it. Once amended click on Validate.
The status of the form will change to 'Validated'.
After the form is validated, close the form.
To submit your notification, click on Submission.
Fill in the drop down menu choices and select the notification you wish to submit.
Only submit one notification at a time.
After 90 minutes, an invoice will be sent to the contact person listed on the notification and those with a TBS finance role.
After selecting submit, you will be required to accept a declaration.
A second video in the series explains how to pay invoices, how to vary Clinical Trials Notifications and the role of your Clinical Trials Repository.