Use this form to request UWA Research Ethics administrators to notify the Therapeutic Goods Administration (TGA) of a Clinical Trial (CTN). The TGA no longer accepts paper applications. They require data-entry into an online system. The following questions are those that the TGA now ask on all notifications of Clinical Trials. Contact Mark Dixon, or phone 08 6488-7613 for help with this form. Submit this form to when complete.

TGA now requires notification and fee payment before the trial can commence working with patients.

Name of Trial:

Contacting you

Name
/ Who should TGA contact with any inquiries about this trial?
Your Email:
Your phone:

Sponsor

Funds Source
/ e.g. NHMRC
Funds Administrator: / (e.g. The University of Western Australia)
Sponsor reference:
(e.g. RA/1/nnn/nnnn)
Sponsor Address:

Address for billing:

/
(Address of Business Unit to be sent the TGA/CTN invoice).

Trial Details

Protocol Number: / For example: RA/4/…
Trial Start Date: / dd/mm/yyyy (cannot be back-dated)
Completion Date: / dd/mm/yyyy
Restricted goods: / Yes or No
Trial Type: /
e.g. Phase 1, 2, 3, or 4; Bioavailability/Bioequivalence; and/or Device
Description
(if necessary): / Optional. e.g. information relating to the stage of development of a device under clinical investigation.
This Trial Involves: / [ ] Animal excipients
[ ] Is being conducted in other countries
[ ] Use of a Medicine
[ ] Involves the use of a Biological
[ ] A Therapeutic Device
[ ] Involves the use of a Medical Device / [ ] Placebo controlled
[ ] Comparator controlled
[ ] Involves a GM organism
[ ] Involves gene therapy
[ ] Is a multicentre trial
[ ] Has relevant preceding trials
Indicate all that apply by entering asterisks [*]
Total Number of
Patients / How many participants to be enrolled, including trail and control groups?
Details of Genetically
Modified Organisms / If applicable.
Medicine/Biological / Enter the GMO product as either a medicine or biological (as applicable) by selecting the check box
Details of Gene Therapy / If applicable.
Details of Biologicals / If applicable.
Therapeutic Area: / [ ] Cardiovascular System
[ ] Central Nervous System
[ ] Ear / Nose / Throat
[ ] Eye
[ ] Gastrointestinal System
[ ] Infections / [ ] Immune System / Inflammation
[ ] Musculoskeletal System
[ ] Neoplastic Disorder
[ ] Other
[ ] Respiratory System
[ ] Skin
Indicate all that apply by entering asterisks [*]

The following section is relevant to either Devices or Drugs

Device Details (investigational and comparators, one table for each)

Trade/product/code: / (including trade name if applicable)
Manufacturer: / Name, address and/or GMP licence number (or relevant exemption) / Australian manufacture?
Yes/No
What sort of combination is this product? / (e.g. Single device, System, Procedure pack, or Software)
Description / Details of design, characteristics, composition, specification, method of use, mode of action and application.
GMDN
(name or code): / (Global Medical Device Nomenclature(GMDN) – if known)
Trial use of this device: / Comparator, investigational product, standard care therapy, or, other (describe)

[Copy this section for each additional produce and for any comparators]

Medicine Details (investigational and comparators, including biologicals one table for each)

Trade/product/code:
Is this a combination product? / Yes or No (comprised of two (or more) active ingredients).
Type of container / e.g. 2 mL ampoule, 5 mL syringe
Dosage Form: / e.g. tablet, injection, implant, spray, …
Dosage and frequency / 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
Presentation: / How is the medicine presented (e.g. packaging, for example: 2mL ampoule, 5mL syringe, blister pack, bottle).
Route of Administration: / e.g. oral
Ingredient: / Name:
Quantity:
Units: (e.g. milligrams)
Intended use: / Investigational product, Comparator, or Standard Care.
Manufacturer: / Name, address and/or GMP licence number (or relevant exemption) / Australian manufacture?
Yes/No

[Copy this section for each additional medicine, and for any comparators]

Placebo Details (if any)

Product name:
Route of Administration: / e.g. oral
Description:

Animal Excipients (if relevant)

Product Name
Species of Origin / e.g. Mouse, Rabbit, Sheep, ...
Tissue / e.g. blood, bone, liver, ...
Preparation / e.g. live, killed, attenuated, extract, ...
Country of Origin

[Copy this section for each additional animal excipient]

Site Details (copy this table for each site involved in the trial)

Name of site:
Site Physical Location (including State): / (full address including state)
Expected Site Start Date:
Principal Investigator
(PI) Name:
PI Contact Title:
PI Contact Phone:
PI Contact Email:
Human Research Ethics Committee (HREC) Name:
HREC Code (if known):
HREC Officer name:
HREC Officer Position:
HREC Officer Phone:
HREC Officer Email:
Site approving authority Name:
Site approver position:
Site approver phone:
Site approver Email:

[Copy this section for each additional site]

TGA no longer accepts paper documents.
Please send this MS-Word file by email (do not print & scan) to: UWA Human Ethics Office, to have it registered into the TGA's Clinical Trials Notification online system.
The Human Ethics office will send a PDF copy of the submitted CTN and the TGA invoice.
TGA now requires notification and fee payment before the trial can commence working with patients.
TGA no longer issued acknowledgements by postal mail – the ethics office will advise you when the CTN is lodged.

UWA Clinical Trial Notification page 4 v1.3