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Clinical trial notification (CTN) form - user guide

Version 1.2, August 2020

21 August 2020

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Creating a new CTN form

The two options below can be used to create a new CTN form.

Option 1

  • Access the dashboard as described in How to login.
  • Select Applications from the top menu on the dashboard.
  • Select Clinical Trial Notification.
screenshot showing the Clinical Trial Notification link under the applications menu on the dashboard

Option 2

  • Access the dashboard as described in How to login.
  • Select Work on drafts under the My work menu on the dashboard. The online Portal menu will be displayed on the left hand side.
screenshot showing the Work on drafts option under the my work menu
  • Select Portal at the top of the menu. This will open further menu options.
  • Select Create Applications & Submissions.
  • Select Clinical Trials and then select Clinical Trial Notification.
screenshot showing the Clinial Trial Notification link on the online portal menu

A blank CTN form will open.

screenshot showing a blank CTN form with the application tab open

There are six (6) possible tabs that may appear through the CTN process: Application, Trial Details, Change to Trial Details, Completion, Validation messages and Changes Made. Depending on the stage of the CTN, only the applicable tabs will display.

New:

screenshot of the Application, Trial Details and Validation messages tabs on the CTN form

Only Trial Details is editable.

Variation:

screenshot of the Application, Trial Details, Change to Trial Details, Completion, Validation messages and Changes Made tabs on the CTN form

Only the Change to Trial Details tab is editable. Any changes made will display in the Changes Made tab.

Completion:

screenshot of the Application, Trial Details, Completion and Validation messages tabs on the CTN form

Only the Completion tab is editable.

The top right hand side of the CTN form displays:

  • the CTN Application ID and version number (this is generated when the form is first opened)
  • the Status of the CTN (for example, 'Draft Loaded')
  • the Client Reference 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 the location of the Application ID, Status and  Client Reference fiel

A red asterisk * indicates a mandatory field.

A grey * asterisk indicates a conditionally mandatory field (the field must be completed if certain conditions are met).

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

screenshot of the link to TGA Code Tables under Public TGA Information on the portal menu

Select the Application tab to begin entering details in the form.

Application tab
Field name Information required
Sponsor Name* This field is pre-populated based on the TBS logon ID used.
Sponsor Address* Select the address recorded in TBS for the sponsor from the drop-down list.
Notification Fee This field will be automatically populated with a dollar amount by the system when the form is validated (see Paying for your CTN for further details).
Trial details tab
Field name Information required
Contact Name*

Contact name is the name of the person nominated by your organisation to receive correspondence from TGA regarding the CTN.

Please note, the contact email address and phone number originally entered on the eBS account will auto-populate to the contact details. If you wish to edit the phone number, please refer to 'Changing contact information' for guidance.

Contact Phone Number* Please note, the phone number of the nominated person will auto-populate. If you wish to edit the phone number, please refer to 'Changing contact information' for guidance.
Contact Email* Please note, the email address of the nominated person will auto-populate. If you wish to edit the email address please refer to 'Changing contact information' for guidance.
Alternative Contact

An alternative contact, may be chosen from the contacts for the agent or sponsor organisation submitting the CTN.

The 'Alternative Contact' option is non-mandatory and is available on the top right hand side of the page.

Protocol Number* Enter the protocol number provided by the sponsor or principal investigator of the clinical trial. This is a unique reference number used to easily identify your trial. This number may be no fewer than 4 and no more than 20 characters.
Expected Trial Start Date*

Enter the date you estimate the trial will be initiated at the first Australian site in the format dd/mm/yyyy or select from the pop-up calendar.

The 'expected trial start date' indicated on the CTN form cannot be a retrospective date.

Expected Completion Date*

Enter the date you estimate the trial will be completed at all Australian sites in the format dd/mm/yyyy or select from the pop-up calendar.

The 'expected completion date' must be a date after the 'expected trial start date'.

Potential use of restricted goods* Select 'Yes' if the trial involves the use of substance(s) that require permission to import under the Customs (Prohibited Imports) Regulations 1956. Otherwise select 'No'.
Title of Study* Enter the title of the clinical trial. The title should include the aim and provide a broad description of the trial. Include, for example: phase, indication(s) being treated, main investigational product and comparators, use of placebo-control, focus of the study, patient population and any other significant or novel aspects.
This Trial* See information below.
Trial Type*

Select the correct check box on the left hand side of the correct trial type(s). More than one check box may be selected.

Medicine or Biological:

  • Select the trial phase(s) for the medicine or biologicals under investigation.

Medical Device:

  • If the trial is investigating a device, select the Device check box.

Bioavailability/Bioequivalence:

  • If the trial is investigating bioavailability or bioequivalence, select the Bioavailability/Bioequivalence check box.
Brief Description of Trial This is a non-mandatory free text field to provide any additional information relating to the trial.
Total number of participants* Select a range of the estimated total number of participants to be enrolled in the trial in Australia from the drop-down list.
Therapeutic area* Select the therapeutic area for the investigational product from the drop-down list.

Changing contact information

The contact information reflected in your eBS account will be auto-populated as per the contact details sections of your CTN submission. Instructions for editing the contact information are included below.

Once a user account has been created, the functionality to update the email address and/or contact name becomes a locked field. To update your email address or contact name, please send an email request to the TBS Helpdesk at ebs@health.gov.au. The TBS Helpdesk team will assist you and update these details on your behalf.

To update your contact number, select your name from the top right corner of your personalised work page or 'dashboard' after signing in. (If you have already proceeded to the "view drafts" or "Submissions" page select 'Back to business portal' from the left hand drop down menu).

screenshot of the how to change your personal contact information

Go to Account Settings, then Edit my Profile. From this screen you will be able to edit your title, phone, mobile, fax and change your listed address. Update the relevant fields and click Update Details. This may take up to an hour to reflect accurately on the Clinical Trial Notification submission.

This Trial*

Select all of the check boxes relevant to your trial. More than one check box may be selected. When selected, check boxes may prompt an additional sub-form that you will need to complete. Additional sub-forms appear at the end of the Trial Details page (above Trial Site Details).

A therapeutic good must be selected in order for the CTN form to be processed. You must select one or more of the following check boxes:

  • Involves the use of a Medicine
  • Involves the use of a Medical Device
  • Involves the use of a Biological
Open all | Close all
If you want to print all details, you need to Open all before you print.
  • Select the check box Involves the use of a Medicine to add medicines to the CTN form.

Placebo details should be entered in the Placebo Details sub-form (see below).

  • Scroll down to the Medicine Details* sub-form.
  • Select the Add Medicine button. This opens a pop-up form with the fields below.
    Field name Information required
    Trade/Product/Code Name* Enter an identifying name(s) of the medicine. If the product has a trade name, product name and code name, enter all three names in the format Trade/Product/Code Name.
    Is this a combination product?* Select 'Yes' if the product is comprised of two (or more) active ingredients. Each active ingredient should be entered under 'Formulation' (see below).
    Is this a cannabis product?* Select 'Yes' if the product is medicinal cannabis.
    Is the cannabis plant used in the manufacture of the product?* Select 'Yes' if the product contains or is manufactured from any part of the cannabis plant.
    Type of container*

    Enter the type of container as defined below.

    The container means the vessel, bottle, tube, ampoule, syringe, vial, sachet, strip pack, blister pack, wrapper, cover or other similar article that immediately covers the goods, but does not include an article intended for ingestion.

    Examples of type of container include 2mL ampoule, 5mL syringe, blister pack, bottle. The terms Various or N/A are not acceptable.

    Dosage Form*

    Select a dosage form from the drop-down list.

    Dosage form is the pharmaceutical form in which a product is presented for therapeutic administration, e.g. tablet, cream. See TGA approved terminology for medicines.

    Route of Administration*

    Select a route of administration from the drop-down list.

    Route of administration means the route by which a therapeutic good is applied on or introduced into the body.

    Formulation*

    Formulation is a list of ingredients used in the manufacture of a dosage form and a statement of the quantity of each ingredient in a defined weight, volume, unit or batch.

    An active ingredient is the therapeutically active component in a medicine's final formulation that is responsible for its physiological action. An excipient is any component of a finished dosage form other than an active ingredient.

    You must at least enter the active ingredient(s). We recommended that you list both the active ingredient(s) and excipient(s) if possible.

    • Select the Add Ingredients button. This opens a pop-up form with the fields below.
      • Ingredient Name*: Enter one ingredient name
      • Quantity*: Enter the numeric part of the ingredient strength/concentration. For example, if the strength of the ingredient is 25 mg, enter 25.
      • Unit*: Select a unit of measurement of the strength/concentration from the drop-down list. For example, if the strength of the ingredient is 25 mg, select milligram.
    • Select the Save and Close button.
    • The details will be added to the list on the Formulation sub-form.
    • Repeat this process for each ingredient you need to add.

    To edit ingredients:

    • Select the Open button beside the ingredient you wish to edit.

    To remove ingredients:

    • Select the check box next to the ingredient(s) you wish to remove.
    • Select the Remove Selected Ingredient(s) button.
    Indication*

    Enter the indication the medicine will be used for in the trial.

    The indication means the specific therapeutic use(s) of the goods.

    Dosage and Frequency*

    Enter the dosage regimen.

    The dosage regimen is the number of doses per given time period, the time that elapses between doses or the quantity of a medicine that is given at each specific time of dosing.

    Intended Use* Select if the medicine is a Comparator; Investigational Medicinal Product; or Standard Care Therapy or Other.
    Intended Use other Description* Please provide a description if 'Other' is selected under 'Intended Use'.
    Is the medicine manufactured in Australia?* Select 'Yes' if the medicine is manufactured in Australia. If not, select 'No'.
    Manufacturer details* Please enter the name and address of the manufacturer.
    GMP licence/clearance number or relevant exemption Please provide the relevant licence number or exemption if available
  • Select the Save and Close button.
  • The details will be added to the list on the Medicine Details* sub-form.
  • Repeat this process for each different medicine and each different medicine strength.

To edit a medicine:

  • Select the Open button beside the medicine you wish to edit.
  • Update any details as needed.

To remove a medicine(s)

  • Select the check box next to the medicine(s) you wish to remove.
  • Select the Remove Selected Medicine(s) button.

Select the checkbox Involves the use of a Medical Device if the product is regulated by us as a medical device.

Review the definition of a medical device at 'What is a medical device?'

'Overview of the regulatory framework for in vitro diagnostic medical devices (IVDs)' also provides further information and definitions of IVDs.

  • Scroll down to the Device Details* sub-form.
  • Select the Add Device button. This opens a pop-up form with the fields below.
    Field name Information required
    Product Name* Enter the product or trade name of the medical device.
    Is this a...?*

    Select the most suitable option from:

    • Medical Device
    • In Vitro Diagnostic Medical Device (IVD)
    Classification

    Select Medical Device Classification from the drop down menu.

    Include the medical device classification (such as Class I, Class III etc. - refer to 'Medical device overview').

    GMDN Search Context To search for a GMDN, select either 'GMDN name' or 'GMDN code'.
    GMDN*

    The Global Medical Device Nomenclature (GMDN) is a collection of internationally recognised terms used to accurately describe and catalogue medical devices, in particular, those products used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.

    Once you have selected the search context above, type in the name or code in the GMDN search field.

    • Select the Search button.
    • A list of possible matches will be returned.
    • Select the correct GMDN from the drop-down list.
    • Select New Search to start again.

    You may need to contact the manufacturer to ascertain which GMDN code is the most relevant for the device. Further information on GMDN is available on the TGA website.

    If a GMDN is not available then you are not required to enter it, however, a 'Description' must be entered in the field below in order for the form to validate.

    Description/Intended purpose for Medical Device* Provide a description of the device including details of design, composition, specification, method of use, mode of action and application.
    Intended Purpose for Trial*

    Select the purpose of the medical device in your trial from:

    • Comparator
    • Investigational product
    • Standard care therapy
    • Other.
    If 'Other' please provide a description Please provide a description if 'Other' is selected under 'Intended Purpose'.
    Manufacturer details* Please enter the name and address of the manufacturer. Manufacturer is defined under section 41BG of the Therapeutic Goods Act 1989. (see Manufacturer section for more details)
  • Select the Save and Close button.
  • The details will be added to the list on the Device Details* sub-form.
  • Repeat this process for each different medical device you need to add.

To edit a medical device:

  • Select the Open button beside the medical device you wish to edit.
  • Update any details as needed.

To remove a medical device:

  • Select the check box next to the medical device(s) you wish to remove.
  • Select the Remove Selected Device(s) button.
  • Select the check box Involves the use of a Biological to add biologicals to the CTN form.

Use the Biological Details sub-form to notify products that are regulated by us as biologicals.

Review the information at 'Products regulated as biologicals' to ensure that the product(s) meet the TGA definition of a biological.

Use the Medicine Details sub-form to notify products that are regulated by us as medicines (such as vaccines and recombinant products).

  • Scroll down to the Biological Details* sub-form.
  • Select the Add Biological button. This opens a pop-up form with the fields below.
    Field name Information required
    Trade/Product/Code Name* Enter an identifying name(s) of the biological. If the product has a trade name, product name and code name, enter all three names in the format Trade/Product/Code Name.
    Is this a combination product?* Select 'Yes' if the product is comprised of two (or more) active ingredients. Each active ingredient should be entered under 'Formulation' (see below).
    Product Description* Enter a description of the biological under clinical investigation, including a name, biological class (e.g. Class 2 etc.), intended use, indication, details of the design, composition, specifications, mode of action and application, list any associated devices and/or medicines and the method of use of the whole biological product.
    Class of Biological Select a class of Biological from the drop-down list.
    Type of container*

    Enter the type of container as defined below.

    The container means the vessel, bottle, tube, ampoule, syringe, vial, sachet, strip pack, blister pack, wrapper, cover or other similar article that immediately covers the goods, but does not include an article intended for ingestion.

    Examples of type of container include 2mL ampoule, 5mL syringe, blister pack, bottle.

    Dosage Form*

    Select a dosage form from the drop-down list.

    Dosage form is the pharmaceutical form in which a product is presented for therapeutic administration, e.g. tablet, cream.

    Route of Administration*

    Select a route of administration from the drop-down list.

    Route of administration means the route by which a therapeutic good is applied on or introduced into the body.

    Ingredients*

    Enter the ingredients used in the manufacture of the biological.

    You must at least enter the active ingredient(s). We recommended that you list both the active ingredient(s) and excipient(s) if possible.

    • Select the Add Ingredients button. This opens a pop-up form with the fields below.
      • Ingredient Name*: Enter one ingredient name.
      • Quantity*: Enter the numeric part of the ingredient strength/concentration. For example, if the strength of the ingredient is 25 mg, enter 25.
      • Unit*: Select a unit of measurement of the strength/concentration from the drop-down list. For example, if the strength of the ingredient is 25 mg, select milligram.
      • Country of Origin: Select the country of origin from the drop-down list.
        • Select the Add Country button to add the country to the list.
        • To remove a country select the check box next to the country you wish to remove. Select the Remove Country(ies) button.
    • Select the Save and Close button.
    • The details will be added to the Ingredients* list.
    • Repeat this process for each ingredient you need to add.

    To edit ingredients:

    • Select the Open button beside the ingredient you wish to edit.
    • Update any details as needed.

    To remove ingredients:

    • Select the check box next to the ingredient(s) you wish to remove.
    • Select the Remove Selected Ingredient(s) button.
    Indication*

    Enter the indication the biological will be used for in the trial.

    The indication means the specific therapeutic use(s) of the goods.

    Dosage and Frequency*

    Enter the dosage regimen.

    The dosage regimen is the number of doses per given time period, the time that elapses between doses or the quantity of a biological that is given at each specific time of dosing.

    Intended Use* Select if the Biological is a Comparator; Investigational Medicinal Product; Standard Care Therapy or Other.
    Intended Use 'other' Description* Please provide a description if 'Other' is selected under 'Intended Use'.
    Is the Biological manufactured in Australia?* Select 'Yes' if the Biological is manufactured in Australia. If not, select 'No'.
    Manufacturer details* Please enter the name and address of the manufacturer.
    GMP licence/clearance number or relevant exemption Please provide the relevant licence number or exemption if available.
  • Select the Save and Close button.
  • The details will be added to the list on the Biological Details* sub-form.
  • Repeat this process for each different biological and each different biological strength.

To edit a biological:

  • Select the Open button beside the biological you wish to edit.
  • Update any details as needed.

To remove a biological:

  • Select the check box next to the biological(s) you wish to remove.
  • Select the Remove Selected Biologicals(s) button.

The fields below also appear below the Biological Details* sub-form.

Enter details of GMOs if any of the therapeutic goods you have listed on the CTN form contain or are produced by GMOs.

Refer to 'Guidance 21: Medicines produced by genetic manipulation' and 'Products regulated as biologicals' for further guidance regarding the regulation of GMOs.

  • A single free text field Details of Genetically Modified Organism will open under the Therapeutic Area field.
  • Enter details of the GMO such as organism name, source, gene technology used.
  • In addition you will then need to enter the GMO product as either a medicine or biological (as applicable) by selecting the check box Involves the use of a Medicine or Involves the use of a Biological.
  • Select the check box Involves Gene Therapy to enter details of gene therapy.

Gene therapy involves the deliberate introduction of genetic material into somatic cells for therapeutic, prophylactic or diagnostic purposes.

Refer to 'Guidance 21: Medicines produced by genetic manipulation' for further guidance regarding gene therapy.

  • A single free text field Details of Gene Therapy* will open.
  • Enter a description of the gene therapy such as the origin of genetic material, delivery techniques etc.
  • Select the check box Is placebo controlled to add placebos to the CTN form.
  • Scroll down to the Placebo Details* sub-form.
  • Select the Add Placebo button. This opens a pop-up form with the fields below.
    Field name Information required
    Product Name* Enter the product name of the placebo.
    Route of Administration*

    Select a route of administration from the drop-down list.

    Route of administration means the route by which a therapeutic good is applied on or introduced into the body.

    Description (including dosage form)* Enter a description of the placebo including dosage form, formulation (ingredients), composition, indications, directions for use, and type of container.
  • Select the Save and Close button.
  • The details will be added to the list on the Placebo Details* sub-form.
  • Repeat this process for each placebo you need to add.

To edit a placebo:

  • Select the Open button beside the placebo you wish to edit.
  • Update any details as needed.

To remove a placebo:

  • Select the check box next to the placebo(s) you wish to remove.
  • Select the Remove Selected Placebo(s) button.
  • Select the check box Is comparator controlled if your study is a comparator controlled trial.
  • This check box does not open a new sub-form and no additional information is required to be entered at this stage.
  • Select the check box Involves Animal Excipients to add animal excipients to the CTN form.

Enter animal excipient details if any of the therapeutic goods you have listed on the CTN form contain animal excipients.

An animal excipient is any component of a finished dosage form other than an active ingredient that contains animal products or is animal derived.

  • Scroll down to the Animal Excipient Details* sub-form.
  • Select the Add Animal Excipient button. This opens a pop-up form with the fields below.
    Field name Information required
    Product Name Enter the name of the product that contains the animal excipient.
    Species of Origin Select the species of origin from the drop-down list.
    Tissue Select the tissue from which the animal excipient originated from the drop-down list.
    Preparation Select the preparation of the animal excipient from the drop-down list.
    Country of Origin Select the country of origin of the animal excipient from the drop-down list.
  • Select the Save and Close button.
  • The details will be added to the list on the Animal Excipient Details* sub-form.
  • Repeat this process for each animal excipient you need to add.

To edit animal excipients:

  • Select the Open button beside the animal excipient you wish to edit.
  • Update any details as needed.

To remove animal excipients:

  • Select the check box next to the animal excipient(s) you wish to remove.
  • Select the Remove Selected Excipient(s) button.
  • Select the check box Has relevant preceding trials if applicable.

Relevant preceding trials may include trials involving the same investigational product conducted by the same sponsor or a follow-on trial conducted after a primary/parent study. The relevant preceding trials are populated from your Clinical Trials Repository.

  • Scroll down to the Preceding Trials* sub-form.
  • Select the check-box beside the relevant preceding trial(s) from the list.
  • Select the check box Is a multicentre trial in Australia if the trial is being conducted at more than one clinical trial site in Australia.
  • This check box does not open a new sub-form and no additional information is required to be entered at this stage.
  • Select the check box Is being conducted in other countries if the trial is also being conducted overseas.
  • Scroll down to the This trial is being conducted in the following Countries* sub-form.
  • Select a country from the drop-down list.
  • Select the Add Country button to add the country to the sub-form.
  • Repeat this process for each country you need to add.

To Remove a Country

  • Select the check box next to the country you wish to remove.
  • Select the Remove Country(ies) button.

Trial Site Details*

  • The Trial Site Details sub-form automatically appears at the bottom of the CTN form. You will need to use this sub-form to add details of each site the trial will be conducted at.
  • Select the Add Site button.
    Field name Information required
    Site Name* Enter the name of the trial site.
    Physical Location* Enter the physical address (street address) of the trial site, including postcode. A postal address will not be accepted.
    State/Territory* Select the state/territory of the trial site from the drop-down list.
    Expected Site Start Date*

    Enter the date you estimate the trial will be initiated at site in the format dd/mm/yyyy or select from the pop-up calendar.

    This date must fall within the range determined by the 'Expected Trial Start Date' and 'Expected Completion Date' for the form to validate.

    Principal Investigator Name* Enter the full name and title of the Principal Investigator at this trial site.
    Contact Phone Number* Enter the phone number (including area code) of the Principal Investigator.
    Contact Email* Enter the email address of the Principal Investigator.
    HREC Name* Enter the name of the Human Research Ethics Committee (HREC) responsible for approving the clinical trial protocol and for monitoring the conduct of the trial.
    HREC Code*

    Enter the unique HREC Code issued by the National Health and Medical Research Council (NHMRC) for this HREC. A list of HRECs registered with NHMRC (which includes the HREC code) is published on the NHMRC website. The current list is available at Human Research Ethics Committees (HRECs) under 'Registration'.

    HREC Contact Officer* Enter the name of a member of the HREC named above. Where possible, this should be the chair or the deputy-chair of the HREC.
    Position* Enter the position description or title of the HREC contact officer.
    Contact Phone* Enter the phone number (including area code) of the HREC Contact Officer.
    Contact Email* Enter the email address of the HREC Contact Officer.
    Name of Approving Authority* Enter the name of the body, organisation or institution that is responsible for approving the conduct of the trial at the particular trial site.
    Approving Authority Contact Officer* Enter the name of the person authorised to represent the body, organisation or institution above.
    Position* Enter the position description or title of the Approving Authority contact officer.
    Contact Phone* Enter the phone number (including area code) of the Approving Authority Contact Officer.
    Contact Email* Enter the email address of the Approving Authority Contact Officer.
  • Select the Save and Close button.
  • The details will be added to the list on the Trial Site Details* sub-form.
  • Repeat this process for each trial site you wish to add.

To edit a trial site:

  • Select the Open button beside the trial site you wish to edit.
  • Update any details as needed.

To remove a trial site:

  • Click on the check box next to the site(s) you wish to remove.
  • Select the Remove Selected Site(s) button.

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