Using the online CTN form

23 August 2016
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For information on logging in to the online portal and accessing a new notification from the dashboard please refer to Getting started with the online CTN form.

Data entry and field types

If you haven't used one of our online forms before, this guidance will introduce you to the different field types that are used, and how to save, edit and validate notification forms.

Fields that have a red asterisk* against them are mandatory, so ensure you properly complete all mandatory fields (otherwise the form will not be validated).

Some fields have a grey asterisk* against them. These fields are conditionally mandatory which means that they must be completed if certain conditions are met. In the example below, you must enter either a GMDN or a Description.

screenshot showing example of grey asterisks used

You can leave fields blank while drafting a notification, and save the draft to finish later. However, please note the form will not validate without completing all the mandatory fields.

Radio Buttons are used when only one option may be selected.

For example:

screenshot showing example of radio button choice

A drop-down list allows the user to select one choice from a list.

screenshot showing example of drop-down list

Data in the drop-down lists is populated from TGA Code Tables. Sponsors can view the TGA Code Tables under the Public TGA Information tab in the CTN online Portal menu.

screenshot showing location of Code Tables

Only enter numbers in this field, and do not enter negative numbers. Decimal points are acceptable if required.

screenshot showing example of numeric field

You can type (or paste) text in these fields.

screenshot showing example of free text field

Some fields will have text limits.

Check boxes are used when more than one option may be selected from a list. Clicking a check box may open up additional fields or sub-forms you will need to complete.

For example:

screenshot showing example of check boxes

The CTN form has various sub-forms where additional details can be added where necessary.

screenshot showing example of add/remove buttons

Entries within sub-forms can also be removed by selecting the Remove Selected... button.

screenshot showing the Remove Selected Site(s) button

Form layout

The top right of the CTN form displays:

  • the Application ID and version number (for example, 'v1'). This is generated when the form is first opened
  • status of the CTN (for example, 'Draft Loaded')
  • a client reference 'free text' field (this field can be used by the sponsor to enter notes or other additional identifying information. This field is not used as a reference by the TGA).

screenshot showing application id location

There are five (5) tabs that make up the CTN form: Application, Trial Details, Change to Trial Details, Completion, and Validation messages. These are located at the top left of the notification form, and you can navigate through the form by clicking on the individual tabs.

screenshot showing form tabs

The action buttons are located at the top left of the form, and are described below.

screenshot showing action buttons

Creating a new notification

To create a new notification from the dashboard view, select Applications from the top menu and then Clinical Trial Notification.

screenshot showing Clinical Trial Notification

To create a new notification from within the Portal menu, click on Create Applications & Submissions on the left side and open the Clinical Trials tab. Click on Clinical Trial Notification.

screenshot showing Clinical Trial Notification in the Portal menu

Begin completing the online form from the Application tab and then click on the Trial Details tab. Refer to the guidance document Completing the online CTN form for further information on the information required in each field.

Saving a draft

You can save a draft notification at any time by selecting Save at the top left of the notification form screen. We recommend you save the application at regular intervals, to ensure no ongoing work is lost.

screenshot showing save location

When the notification form is first saved, the status will update from Draft Loaded to Draft Saved.

screenshot showing example of application status

screenshot showing example of application status

Once a draft is saved you can exit the online portal and open the draft later to continue completing or editing the form.

Editing a draft

You can edit your drafts at any time prior to submitting them.

To edit a saved draft, select Work on drafts under My work on the dashboard screen.

screenshot showing work on drafts

Alternatively, you can click on View Drafts from within the online Portal menu.

screenshot showing work on drafts in Portal menu

You will then see all of the saved drafts that your access allows.

screenshot showing saved drafts

Please note that you may have more than one page of drafts in your online portal. If you are unable to see the draft notification you are looking for, you can select the next page of your drafts screen.

screenshot showing saved drafts page of drafts

You can also search for a notification in the drafts list using the Filter on field. You can filter on parameters such as Date, Status, Client Reference or Identifier. Enter the parameters you wish to search on and then click Go.

screenshot showing filter on fields

Click on the notification you wish to edit. The clinical trial notification page will open. Click on the Trial Details tab and go to the relevant fields to make any changes.

screenshot showing Trial Details fields

Validation

The notification form must be validated before it can be submitted, although it can be validated at any time during drafting. (We recommend that you save your draft before selecting validate.)

To validate the form, select Validate located at the top left of the notification form.

screenshot showing validate location

The validation process checks that all compulsory fields are completed, and that information has been entered in the correct format (e.g. email addresses).

After selecting Validate you will be taken to the Validation messages tab. Wait to see if any validation messages are displayed.

The Validation messages tab will display any fields that need to be corrected before validation can proceed.

If there are no validation messages, the status of the notification form (top right of window) will change from Draft to Validated.

screenshot showing example of status - validated

If there are validation messages, the status of the notification form (top right of the window) will change to Draft Not Valid.

screenshot showing example of status - draft not valid

You can click on a validation message in the list. This will take you to the field in the form that requires editing.

screenshot showing example of validation messages

An exclamation mark will appear on the right hand side of certain fields containing invalid information:

screenshot showing example of error message

Once you have corrected all the invalid fields, you should save the form before trying to validate again.

Submitting

Once the form has validated, select Close.

If you select Save after successfully validating the form, it will revert back to draft status, and you will need to start the validation process again before you can submit.

screenshot showing close location

To submit the notification, select Submission from the Portal menu (under the Clinical Trials menu):

screenshot showing submission location

(If you are unable to see Submission in your online portal, you may not have a Submission user role. You will need to contact your organisation's administrator to update your system role.)

The Clinical Trials Submissions page will then open:

screenshot showing clinical trial submissions page

Select the appropriate details from the drop down lists for each field, and if you want the selected sponsor invoiced.

Please only submit one notification form at a time.

When you have completed the required information, click on Submit.

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 declaration

If you select Decline you will be taken back to the Clinical Trials Submissions page.

If you select Close you will be taken back to the View Drafts page.

If you select Accept you will be taken to a page which tells you the submission of your CTN has been successful.

From this page you can print the invoice by selecting the Print Invoice button in the top left corner of the page. This will open another window displaying your invoice to be printed.

screenshot showing how to print invoice

Paying invoices

To pay an invoice, please see TGA Payment Options.

Your organisation's TGA Business Services (TBS) Administrator can assign users with Financial access. A user with Financial access can view invoices and make payments. A user may have multiple system roles. Further information on the Financial role is available on the TGA website.

Guides for each user role are available on our website at TGA Business Services - how to use the site:

Certain variations to a previously notified CTN incur a fee. Please contact the clinical trials team at for advice.

Editing a submitted form or a push back

If you have submitted a notification and it needs to be edited, you will need to contact the clinical trials team at . You can request the clinical trials team to return the notification to your drafts list for editing.

The TGA may also return a notification (push back) for you to edit before processing can be completed. The returned notification will appear in red under your View Drafts.

You will then be able to make the required changes to your draft. The returned notification form will need to be validated before it can be submitted again (see Validation above).

Once the notification has been processed, any further changes will need to be made by varying the notification via your Clinical Trials Repository. Please refer to Varying trial details for further information.

How to check the status of your CTN

When you have lodged a CTN it will appear in the Submissions list.

To access the Submissions list you can select View Submissions under My work on the dashboard screen.

screenshot showing view submissions

Alternatively, select View Lodged Submissions in the Portal menu, and the list will display.

screenshot showing lodged submissions

You can check the status of the submission under the Workflow Status column.

If a CTN is listed under your View Lodged Submissions, then it has not yet been processed by the TGA. You cannot make any changes to an online notification listed under View Lodged Submissions. If you have submitted a notification and it needs to be edited see Editing a submitted form or a push back above.

When the TGA has processed your online notification it will appear in the Clinical Trials Repository. The TGA reviews the notification to ensure that required information has been completed correctly as indicated in the guidance document Completing the online form.

To open, select Your TGA Information from the Portal menu. Then select Clinical Trials Repository from the Your TGA Information menu.

To find a processed CTN, select Your TGA Information from the Portal menu. Then select Clinical Trials Repository from the Your TGA Information menu.

screenshot showing clinical trials repository

If your submitted CTN appears in this list, it has been processed by the TGA.

screenshot showing clinical trials repository listing CTN documents processed by the TGA

View drafts or lodged submissions

Select Portal (located at the very top of the TBS menu).

  • For Drafts select View Drafts

    Note: You may see draft CTN forms along with other drafts if you use TBS for other purposes.

  • For submitted CTN forms select View Lodged Submissions

    Note: You may see submitted CTN forms along with submissions of other types if you use TBS for other purposes.

screenshot showing view drafts and lodged submissions

Alternatively you can click on Work on drafts or View Submissions under My work on the dashboard screen.

screenshot showing My work

View active and closed clinical trials

Select Portal (located at the very top of the TBS menu). Select Your TGA information. Select Clinical Trials Repository

screenshot showing clinical trials repository

Printing, deleting, and copying

You can print the notification form at any time before or after submitting it:

  • Click the Print Preview button located at the top left of the notification form.

    screenshot showing print preview location

  • You can also print preview your submissions from View Drafts, View Lodged Submissions or Clinical Trials Repository. Click on the drop down arrow, located at the far left of the notification you wish to print and select Print Preview from the options available. See an example from the Clinical Trials Repository below.

    screenshot showing Print Preview

You can delete a draft notification at any point up until the time you submit it.

To do this, open the View Drafts link found at the top of the Portal menu.

screenshot showing view drafts location

Select the drop down arrow (located at the far left of each draft notification - it will turn green when selected), then select Delete.

screenshot showing delete options

You can copy any draft notification form to create a new draft. Information from the copied draft is retained for every field.

Go to the draft list, located via the View Drafts link in the Portal menu.

Click the drop down arrow located at the far left of the listing, and then click on Copy. A dialog box will ask if you are sure you want to copy this draft notification.

screenshot showing dialog box

Selecting OK creates a new draft notification form which opens with a new notification ID.

Varying trial details

To vary the details of a submitted (and processed) CTN, select Work on drafts under My work on the dashboard screen.

screenshot showing Work on drafts location

Alternatively, from within the Portal menu, select Your TGA Information then select Clinical Trials Repository.

screenshot showing clinical trials repository location

Once the repository is open, you will see a list of processed CTNs. Select the drop down arrow for 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 options

After selecting Vary a webpage message will appear. Select OK to proceed.

screenshot showing variation message

The CTN you wish to vary will then open, and it looks and functions in the same way a new (draft) CTN form does.

However, the only tabs that will be relevant to submitting a change are the Application tab, Change to Trial Details tab, and the Validation tab. The Trial details tab and the Completion tab are locked from editing for this process.

The information required in each field is the same as described within the Completing the online CTN form guidance.

Enter the variation details, validate your notification and submit the variation. Refer to the Validation and Submitting sections above.

Please note if the submission is currently under review with the TGA you will not be able to vary the trial and the following message will appear. You will need to wait until the TGA has processed the previous submission for you to make a variation.

screenshot showing Variation message

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

screenshot showing error message

Submitting a completion advice

To submit a completion advice to us, select Your TGA Information then select Clinical Trials Repository on the Portal Menu.

screenshot showing clinical trials repository location

Once the repository is open, you will see a list of processed CTNs. Select the drop down arrow for the CTN you want to complete (located at the far left of each CTN - it will turn green when selected), then select Complete.

screenshot showing options

The CTN you want to complete will then open, and it looks and functions in the same way a new (draft) CTN form does.

However, the only tabs that will be relevant to submitting a change are the Completion tab and the Validation tab.

The information required in each field of the Completion tab is described within the Completing the online CTN form guidance.

Enter the completion details, validate your notification and submit the completion advice. Refer to Validation and Submitting sections above.

How to use the online form button

screenshot showing How to use the online CTN form location

This button will link you to the online CTN form guidance documents available on the TGA website.

screenshot showing Clinical Trial Notification Application Guide

Before submitting your application(s) please read the declaration below and click the Accept button to proceed with this submission; or click on the Decline button to return to the Submission form.

In this declaration, unless the contrary intention appears:

I means the individual assigned to the eBS login ID associated with the submission of this form to the TGA.

Secretary means the Secretary of the Department of Health and includes a delegate of the Secretary.

Sponsor means the company, organisation, institution, body or individual that is notifying the TGA as named in the 'Sponsor Name' field located on the application tab of this notification.

By clicking the Accept button:

I declare that I am authorised by the sponsor to notify the TGA on its behalf in relation to this clinical trial.

I acknowledge that:

  • the sponsor is taking overall responsibility for the trial
  • the relevant goods only remain exempt by reason of their use in the clinical trial only for so long as:
    • the approval of the goods for the trial has been given by the sponsor (if the sponsor is conducting the trial), or by the body or organisation conducting the trial for the sponsor, having regard to the advice of the ethics committee responsible for monitoring the conduct of the trial, on terms no less restrictive than terms advised by that committee
    • the sponsor has not received advice from the ethics committee that is inconsistent with the continuation of the trial
    • the requirements in regulation 12AD of the Therapeutic Goods Regulations 1990 (in the case of therapeutic goods other than medical devices) and regulation 7.5 of the Therapeutic Goods (Medical Devices) Regulations 2002 (in the case of medical devices) are complied with, including that the use of therapeutic goods in the trial must be in accordance with the Guidelines for Good Clinical Practice and the National Statement on the Ethical Conduct in Research Involving Humans published by the National Health and Medical Research Council, as defined in the Therapeutic Goods Regulations
    • the Secretary has not under Item 3 of Schedule 5A of the Therapeutic Goods Regulations (in the case of therapeutic goods other than medical devices) or Item 2.3 in Part 2 of Schedule 4 of the Therapeutic Goods (Medical Device) Regulations 2002 directed that the trial not be conducted on the basis that the Secretary has become aware that to conduct the trial would be contrary to the public interest
  • the Secretary can under the Therapeutic Goods Act 1989 (the Act), require the sponsor to provide specified information or documents relating to any exempt goods
  • the Secretary can provide information obtained in response to an authority or the Commonwealth, or a State or Territory that has functions in relation to therapeutic goods or the registration or medical practitioners or pharmacists in the relevant State or Territory
  • it is an offence under the Act to fail to provide that information or documents required by the Secretary, or to provide information or documents that are false or misleading in a material particular, to the Secretary
  • it is a requirement of the Guidelines on Good Clinical Practice that the sponsor report all serious and unexpected adverse reactions arising from the use of the relevant goods in the trial to the TGA
  • it is a serious offence under Commonwealth law to provide information for the purposes of this notification that is false or misleading in a material particular.

I declare that all information provided for the purposes of the notification is true and accurate and that all required information has been included.