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Clinical trial notification (CTN) form - user guide

V1.2, August 2020

21 August 2020

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Manual submission

Once the CTN form has been validated, the form can then be submitted to us by a user with a 'submitter role'.

Note: If you clicked Submit in the drafts section after validating, you will be automatically re-directed to the Submissions page.

If you are unable to select Submit or Submission in your online portal, you may not have a 'submitter user role'. You will need to contact your organisation's administrator to update your system role. See Roles: what each user can do and Drafter/submitter role specific information.

Manually access submission page

The two options below can be used to manually access the Clinical Trials Submissions page. If you selected Submit from the drafts screen you will automatically be taken to the Submission page.

Option 1

  • Access the dashboard as described in How to login.
  • Select Applications from the top menu on the dashboard.
  • Select Submission under the Clinical Trials heading.
screenshot showing the Submission link on the Applications menu

Option 2

  • If you are already working within the online Portal menu, select Portal at the top of the menu.
  • Select Create Applications & Submissions.
  • Select Clinical Trials and then select Submission.
screenshot showing the Submission link in the portal menu

The Clinical Trials Submissions page will then open.

screenshot showing Clinical Trials Submissions page

Choose the relevant details:

Field name Information required
Client Name This field is pre-populated based on the TBS logon ID used.
Applicant Billing Address* Select the billing address from the drop-down list. This will auto-populate if there is only one option.
Sponsor Name* Select the sponsor name from the drop-down list. This will auto-populate if there is only one option.
Application Type* Select Clinical Trial Notification.
Invoice Selected Sponsor? Select Yes or No as applicable.
Eligible Applications* Select the check box beside the CTN form you wish to submit. Select only one CTN form per submission. If you access this screen from the drafts submission the CTN you were working on will be automatically selected (ticked off) for submission.

When you have completed the required information, click the Submit button at the top of the form.

screenshot showing the Submit button at the top of the Clinical Trials Submissions page

Sponsor declaration

After selecting submit, you will be required to accept (or decline) a declaration, which includes acknowledging that the sponsor is taking overall responsibility for the trial. The full text of the sponsor declaration can be found below.

screenshot showing Sponsor Declaration
  • If you select the Decline button you will be taken back to the Clinical Trials Submissions page.
  • If you select the Close button you will be taken back to the online Portal.
  • If you select the Accept button you will be taken to a page which advises you the submission of your CTN has been successful.
screenshot showing successful submission message

Select the Close button to exit. Your CTN has now been submitted to us for processing. See How to check the status of your CTN for information on checking the status of your CTN.

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.

Otherwise you can now move on to Paying for your CTN.

Once the CTN form has been submitted and paid for, we will review the CTN to ensure data has been entered correctly.

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