Completing the online CTN form

Application tab

Sponsor Name

This field is pre-populated based on the TBS logon ID used.

Sponsor Address

Select address recorded in TBS for this sponsor (drop-down list).

Notification Fee

This field will be populated with a dollar amount once the form is validated. Please note that certain variations to a previously notified CTN incur a fee. Please contact the clinical trials team at clinical.trials@tga.gov.au for advice.

Trial Details tab

Contact Name

The person who will receive correspondence from the TGA regarding the CTN. All correspondence and email enquiries will be sent to this person.

Contact Phone Number

Phone number (including area code) of the contact person. Please note that only one phone number can be entered.

Contact Email

Email address of the contact person. Please note that only one email address can be entered. Enter this email address again in the 'Confirm Email' field.

Protocol Number

The unique reference number the TGA uses to easily identify your trial. The protocol number is provided by the sponsor or principal investigator of the clinical trial. This number may be no fewer than 4 and no more than 20 characters.

Expected Trial Start Date

The date you estimate the trial will be initiated at the first Australian site; either selected from a pop-up calendar or entered in the format dd/mm/yyyy. The 'expected trial start date' indicated on the CTN form cannot be a retrospective date.

Expected Completion Date

The date you estimate the trial will be completed at all Australian sites; either selected from a pop-up calendar or entered in the format dd/mm/yyyy.

Potential use of restricted goods

If this trial involves the use of a medicine, the importation of which is prohibited under the Customs (Prohibited Imports) Regulations 1956, select the radio button 'Yes', otherwise select 'No'.

Title of Study

Title should indicate the aim, and give 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.

Trial Type

Indicate the phase/s the trial will encompass for a medicine or biological under clinical investigation. Please ensure you select the correct check box on the left side of the correct trial type.

If the trial is investigating:

• bioavailability or bioequivalence, select the Bioavailability/Bioequivalence check box
• a device, select the Device check box.

Brief Description of Trial (if necessary)

This is a non-mandatory free text field to provide any additional information relating to the 'Trial Type' (if required), e.g. information relating to the stage of development of a device under clinical investigation.

This Trial

Select any check boxes which are relevant to your trial.

When selected, most check boxes will open a new sub-section to the form. These will be added to the bottom of the Trial Details page.

You can find instructions for completing each of these subsections Sub-sections of the CTN form below.

Total number of participants to be enrolled in the Trial

Select a range of the estimated total number of participants to be enrolled in the trial in Australia (drop-down list).

Therapeutic Area

Select the therapeutic area the investigational product will be used for in this trial (drop-down list).

Change to Trial Details tab

The process for varying the details of a previously notified CTN is explained within Using the online CTN form.

The type and description of the information required in this section of the online form is the same as what is described under the Trial Details tab.

Completion tab

Name

The name of the person responsible for submitting the completion advice.

Position

Position or title of the person provided in the 'Name' field above.

Contact Phone Number

Phone number (including area code) of the person provided in the field 'Name' above.

Contact Email

Email address of the person provided in the field 'Name' above.

Date Trial Completed

The date the trial was completed at all Australian sites; either select from a pop-up calendar or enter it in the format dd/mm/yyyy. Please refer to the Clinical trials FAQs for information on when to submit a clinical trial completion advice.

Completion Reason

Select the reason for trial closure (drop-down list).

Validation Messages tab

This process is explained within Using the online CTN form.

Animal Excipient Details

This sub-form appears at the bottom of the Trial Details tab when the check box Involves Animal Excipients is selected.

To add the details of animal excipients, select the Add Animal Excipient button on the Animal Excipient Details sub-form. This opens a pop-up form with the fields below.

Once the pop-up form is completed, select the Save & Close button on the pop-up form to add the details to the list on the Animal Excipient Details sub-form.

Repeat this process for each animal excipient you need to add.

Product Name

The name of the product that contains the animal excipient.

Species of Origin

Select the origin of the species (drop-down list).

Tissue

Select the tissue from which the animal excipient originated (drop-down list).

Preparation

Select the preparation of the animal excipient (drop-down list).

Country of Origin

Select the country of origin of the animal excipient (drop-down list).

Medicine Details

This sub-form appears at the bottom of the Trial Details tab when the check box Involves the use of a Medicine is selected.

To add the details of a medicine, select the Add Medicine button on the Medicine Details sub-form. This opens a pop-up form with the fields below.

Once the pop-up form is completed, select the Save & Close button on the pop-up form to add the details to the list on the Medicine Details sub-form.

Repeat this process for each medicine you need to add.

Each 'separate and distinct' medicine must be entered in a separate sub-form. Each different strength of a product must also be entered in a different sub-form.

Refer to section 16 of the Therapeutic Goods Act 1989 for a definition of 'separate and distinct'.

Please note that placebo details should be entered in the Placebo Details sub-form (see below). Please tick Is placebo controlled under This Trial on the Trial Details tab for the Placebo Details sub-form to appear.

Trade/Product/Code Name

Enter an identifying name/s of the medicine under clinical investigation. 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?

Please select 'Yes' if the product under clinical investigation is comprised of two (or more) active ingredients. Both active ingredients should be entered in the 'Add ingredients' box.

Type of container

Please describe the type of container (e.g. packaging), i.e. 2mL ampoule, 5mL syringe, blister pack, bottle.

In relation to therapeutic goods, 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. A code table which provides a list of different container types can be found under Public TGA Information on the Portal menu.

Dosage Form

Select a dosage form (drop-down list).

Route of Administration

Select a route of administration (drop-down list).

Formulation

This is also a mandatory field. You may list both active and inactive ingredients. At least the active ingredients must be entered.

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.

See 'Add ingredients' box (Medicines).

Indication

Means the specific therapeutic use(s) of the goods in this clinical trial.

Dosage and Frequency

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 Comparator; Investigational Medicinal Product; or Standard Care Therapy.

Refer to the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) for a definition of comparator or investigational product.

Is the medicine manufactured in Australia?

Yes/No

Manufacturer details

If the medicine is manufactured in Australia, provide name, address and/or GMP licence number (or relevant exemption).

'Add ingredients' box (Medicines)

To list all medicine ingredients in the Formulation field, select the Add ingredients button on the Medicine Details pop-up box. This opens a pop-up form with the fields below.

Once the Medicine Ingredient Details pop-up form is completed, select the Save & Close button on the pop-up form to add the details to the Formulation list.

Repeat this process for each medicine ingredient you need to add. Please add the ingredient details of one product only. Different strengths of a product must be entered on a separate Medicine Details sub-form.

Ingredient Name

Please enter the ingredient name/s.

Quantity

Please enter the numeric part of the quantity i.e. if the concentration of the active ingredient is 25 mg/L, enter 25.

Unit

Please select a unit of measurement from the drop-down list i.e. if the concentration of the active ingredient is 25 mg/L, enter milligram/litre.

Device Details

This sub-form appears at the bottom of the Trial Details tab when the following check boxes are selected:

• 'Involves the use of a Therapeutic Device'
• 'Involves the use of a Medical Device'

Choose only one of the above options to describe the device. To add the details of a device, select the Add Device button on the Device Details sub-form. This opens a pop-up form with the fields below.

Once the pop-up form is completed, select the Save & Close button on the pop-up form to add the details to the list on the Device Details sub-form.

Repeat this process for each device you need to add.

Therapeutic Device

Please ensure you tick 'Involves the use of a Therapeutic Device' for therapeutic devices only. This option should not be chosen for a medical device.

A definition of a therapeutic device can be found under section 3 of the Therapeutic Goods Act 1989. Further information is also available on the TGA website under Other therapeutic goods.

Medical Device

Please ensure you tick 'Involves the use of a Medical Device' for medical devices only.

A definition of a medical device can be found under section 41BD of the Therapeutic Goods Act 1989. Further information can be found on the TGA website under What is a medical device?

Each different 'kind of medical device' must be entered in a separate sub-form. Refer to section 41BE of the Therapeutic Goods Act 1989 and regulation 1.6 of the Therapeutic Goods (Medical Devices) Regulations 2002 for a definition of 'kinds of medical devices'.

Please also refer to the TGA website for further information and definitions of in vitro diagnostic medical devices (IVDs).

Product Name

Please enter the product or trade name of the device under clinical investigation.

Is this a...?

Please select the most suitable option from single device; system; procedure pack; software.

A definition of a system or procedure pack can be found in the Therapeutic Goods Act 1989 (section 41BF).

Please select software if the device would be best described as software. Software is regulated under the therapeutic goods legislation if it meets the definition of a medical device. Please refer to Regulation of medical software and mobile medical 'apps' for further information.

Manufacturer

Please enter the name of the manufacturer of the device. Manufacturer is defined under section 41BG of the Therapeutic Goods Act 1989 and is one of the characteristics that defines a 'kind of medical device' (see section 41BE of the Therapeutic Goods Act 1989). Various or N/A will not be acceptable.

GMDN Search Context

To search for a GMDN select 'GMDN name' or 'GMDN code'.

GMDN

Once you have selected the search context as above, type in the name or code in the GMDN search field. Click on the Search button and a list of possible GMDN codes will be returned. Select the correct GMDN from the drop-down list. Click on New Search to start again.

The Global Medical Device Nomenclature (GMDN) is a system of internationally agreed terms used to identify medical devices. The GMDN code is one of the characteristics that defines a 'kind of medical device' (see section 41BE of the Therapeutic Goods Act 1989).

Please 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 the device description (see below) is required to be entered in order to validate the online form.

Description

Provide a description of the device including details of design, composition, specification, method of use, mode of action and application. Please also include the medical device classification (such as Class I, Class III etc - refer to the TGA website for examples).

The unique product identifier (UPI) should also be included for any Class III, active implantable medical device (AIMD), or Class 4 IVD medical device, other than an immunohaematology reagent Class 4 IVD medical device (as outlined under regulation 1.6 of the Therapeutic Goods (Medical Devices) Regulations 2002).

Intended Purpose

Comparator; Investigational product; Standard care therapy; Other.

Refer to the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) for a definition of comparator or investigational product.

If 'Other' please provide a description

Please provide a description if 'Other' is selected an 'Intended Purpose'.

Placebo Details

This sub-form appears at the bottom of the Trial Details tab when the check box Is placebo controlled is selected.

To add the details of a placebo, select the Add Placebo button on the Placebo Details sub-form. This opens a pop-up form with the fields below.

Once the pop-up form is completed, select the Save & Close button on the pop-up form to add the details to the list in the Placebo Details sub-form.

Repeat this process for each placebo you need to add.

Product Name

Enter the product name of the placebo used in the clinical investigation.

Route of Administration

Please select a route of administration from the drop-down list.

Description (including dosage form)

Please provide an additional description and the dosage form of the placebo to be used in the clinical trial. Applicable description may include dosage form, formulation, composition, design specification, indications, directions for use, and type of container.

Details of Genetically Modified Organism

This field appears on the CTN form when the Involves a Genetically Modified Organism check box is selected.

This is a free text field only. Please provide details of the GMO such as a name, description, details of the design, compositions, specifications, mode of action and application. List the method of use of the product. Further information on the regulation of genetically modified organisms is available on the TGA website.

Please note that you must also enter the genetically modified organism (GMO) in the medicine or biological details sub-forms as applicable.

Multicentre Trial in Australia

Tick the Is a multicentre trial in Australia box for multicentre trials conducted in Australia. A new sub-form will not appear and no further information is required to be entered.

Trial Conducted in Other Countries

This sub-form appears at the bottom of the Trial Details tab when the check box Is being conducted in other countries is selected.

To add a country to the list, select a country from the drop-down list and add it by clicking the Add Country button on the sub-form.

Repeat this process for each country you need to add.

Biological Details

This sub-form appears at the bottom of the Trial Details tab when the check box Involves the use of a Biological is selected.

To add the details of a biological, select the Add Biological button on the Biological Details sub-form. This opens a pop-up form with the fields below.

Once the pop-up form is completed, select the Save & Close button on the pop-up form to add the details to the list in the Biological Details sub-form.

Repeat this process for each biological you need to add.

The Biological Details sub-form should only be used to notify goods that are regulated by the TGA as biologicals. If the product is regulated as a medicine, please use the Medicine Details sub-form.

Please review the definition of a biological on the TGA website to ensure that the product is notified as the correct type of therapeutic good.

Further information on the scope of products that are regulated as biologicals can be found in Section 1.1 of the Australian Regulatory Guidelines for Biologicals (ARGB).

Each 'separate and distinct biological' must be entered in a separate Biological Details sub-form. Refer to section 32AB of the Therapeutic Goods Act 1989 and regulation 11A of the Therapeutic Goods Regulations 1990 for a definition of a 'separate and distinct biological'.

Trade Product/Code Name

Please enter the name of the Human Cell & Tissue under clinical investigation. If the product has a trade name, a product name and code name, enter all three names in the format Trade/Product/Code/Name.

Is this a combination product?

Please select 'Yes' if the product under clinical investigation is comprised of two (or more) active ingredients. Both active ingredients should be entered in the 'Add ingredients' box.

Type of container

Please describe how the Human Cell & Tissue is presented i.e. 2mL ampoule, 5mL syringe.

In relation to therapeutic goods, 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. A code table which provides a list of different container types can be found under Public TGA Information on the Portal menu.

Dosage form

Please select a dosage form from the drop-down list.

Route of administration

Please select a route of administration from the drop-down list.

Ingredients

This is also a mandatory field. At least the active ingredients must be entered.

See 'Add ingredients' box (Biologicals).

'Add ingredients' box (Biologicals)

To list all biological ingredients in the Ingredients field, select the Add Ingredients button on the Biological Details pop-up box. This opens a pop-up form with the fields below.

Once the Biological Ingredient Details pop-up form is completed, select the Save & Close button on the pop-up form to add the details to the Ingredients list.

Repeat this process for each biological ingredient you need to add. Please add the ingredient details of one product only. Different strengths of a product must be entered on a separate Biological Details sub-form.

Ingredient name

Please enter ingredient name/s.

Quantity

Please enter the numeric part of the quantity i.e. if the concentration of the active ingredient is 25 mg/L, enter 25.

Unit

Please select a unit of measurement from the drop-down list i.e. if the concentration of the active ingredient is 25 mg/L, enter milligram/litre.

Country of origin

Please select the country of origin from the drop-down list, then click the Add Country button.

Product description (at bottom of Biological Details form)

Appears when the Involves the use of a Biological check box is selected.

Please enter:

• a description of the biological under clinical investigation, including a name, description, biological class (e.g. Class 2 etc.), intended use, indication, details of the design, compositions, specifications, mode of action and application, list any associated devices and/or medicines and the method of use of the whole biological product.
• for a biological not in phase 1, is it manufactured in Australia? Select 'yes' or 'no'.
• manufacturer details (name, address and/or GMP details).

Comparator Controlled

Tick the box Is comparator controlled for comparator controlled trials. A new sub-form will not appear and no further information is required to be entered.

Details of Gene Therapy

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

This field appears on the CTN form when the Involves gene therapy check box is selected. This is a free text field only.

Please note that you must also enter the gene therapy in the medicine or biological details sub-forms as applicable.

Please provide any further details such as a name, description, details of the design, compositions, specifications, mode of action and application. List the method of use of the product.

Please note

The following European Union (EU) guidelines relating to gene therapy have been adopted in Australia:

• EMEA/CHMP/ICH/607698/2008 ICH Considerations. Oncolytic Viruses
• EMEA/CHMP/GTWP/125459/2006 Guideline on the Non-Clinical Studies required before First Clinical Use of Gene Therapy Medicinal Products
• EMEA/273974/2005 Guideline on Non-Clinical Testing for Inadvertent Germline Transmission of Gene Transfer Vectors
• CPMP/BWP/3088/99 Note for Guidance on the Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products

Preceding Trials

This field appears on the CTN form when the Has relevant preceding trials check box is selected if any preceding trials are available. The relevant preceding trials are populated from your Clinical Trials Repository.

Please select the check box for each trial listed that is relevant to this notification.

Relevant trials may include trials involving the same investigational product conducted by the same sponsor or for a follow on post a primary/parent study.

This information may be used by the TGA where a safety issue may be of public health concern.

Trial Site Details

Clicking the Add Site button will open a pop-up form with the fields below.

Once the pop-up form is completed, select the Save & Close button on the pop-up form to add the details to the list in the Trial Site Details sub-form.

Repeat this process for each trial site you need to add.

Site Name

Name of the trial site.

Site Physical Location

The physical address (street address) of the trial site, including postcode. Do not use postal addresses.

For large institutions, the address doesn't need to include specific department details unless:

• this is essential to identify the location, or
• the unit/body/practice operates as a separate entity within a campus.

State/Territory

Select the State/Territory of the trial site (drop-down list).

Expected Site Start Date

The date you estimate the trial will be initiated at this trial site; either selected from a pop-up calendar or entered in the format dd/mm/yyyy. Note that this date must fall within the range determined by the 'Expected Trial Start Date' and 'Expected Completion Date' for the form to validate.

Name (Principal Investigator)

Full name and title of the Principal Investigator at this trial site.

Contact Phone Number

Phone number (including area code) of the Principal Investigator.

Contact Email

Email address of the Principal Investigator.

HREC Name (HREC Details)

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

The unique HREC Code issued by the National Health and Medical Research Council (NHMRC) for this HREC.

• List of Human Research Ethics Committees registered with NHMRC (pdf,225kb)

HREC Contact Officer

A member of the HREC named above. Where possible, his should be the chair or the deputy-chair of the HREC.

Position

Position description or title of the HREC contact officer.

Contact Phone

Phone number (including area code) of the HREC Contact Officer.

Contact email address

Email address of the HREC Contact Officer.

Name of Approving Authority

The institution or organisation at which the trial will be conducted which gives the final approval for the conduct of the trial at the site.

Approving Authority Contact Officer

The person authorised to represent the body, organisation or institution at which the clinical trial will be conducted.

Position

Position description or title of the Approving Authority contact officer.

Contact Phone

Phone number (including area code) of the Approving Authority Contact Officer.

Contact Email

Email address of the Approving Authority Contact Officer.