Austin Health Clinical Trials Notification form guidelines
Do I need a CTN for my clinical research?
If your project includes one of the following then a Clinical Trial Notification (CTN) form must
be completed and must be included in your Ethics & Governance submission:
 Any product not approved by the Therapeutic Goods Administration (TGA). This could
be a drug, therapeutic device or even diagnostic machines.
 Use of an approved product in a clinical trial beyond the conditions of its approval (i.e.
in an unapproved indication, age group, dosage, administration route)
How do I Complete a CTN Form?
 An original CTN (1 only and preferably on blue paper) must be submitted with the
ethics submission. If the study is multi-site you will need to submit a CTN for each site
to the reviewing HREC.

Please ensure all questions on the form are complete before submission to the Ethics
Office.

The CTN can be submitted to Ethics & Research with no signatures.

Please note that all unregistered therapeutic goods need to be listed in the CTN, this
includes a placebo.

Trial site details for a study being conducted at Austin Health
Site: Austin Health
Site Address: 145 Studley Rd
Heidelberg, 3084

HREC details for a study being reviewed by Austin Health HREC
HREC name: Austin Health Human Research Ethics Committee
HREC address: 145 Studley Rd
Heidelberg 3084
Name (Print): Prof David Taylor
Position: HREC Chairperson
Phone: 03 9496 4711
Fax: 03 9496 4103

Authority approving details for studies being conducted at Austin Health
Approving Authority name: Austin Health
Address: 145 Studley Rd
Heidelberg 3084
Name (Print): Dr Sianna Panagiotopoulos
Position: Manager, Office for Research
Phone: 03 9496 5088
Fax: 03 9496 4103
Who is the sponsor?
The sponsor of a clinical trial can be:
 An individual (eg medical practitioners)
 An organisation (eg hospital, Area Health Service, non-government organisations) or
 A Company (eg pharmaceutical companies)
The sponsor is responsible for the overall conduct of the study.
I have ethics and governance approval what’s next?
Once the sponsor, the principal investigator, the Chairman of the HREC and the person
responsible from the Approving Authority have signed the CTN Form, it is submitted to the
TGA with the notification fee. Please visit the TGA website for further details.
CTN guidelines
Version 2
14 March 2013
Investigator Initiated Studies
If the study is Investigator Initiated Austin Health will usually sign off on the CTN as the
sponsor. It is the responsibility of the Investigator to submit the completed CTN to the TGA
prior to study commencement. The Investigator is also responsible for organising and
submitting the CTN trials completion form.
CTN faux pas
The CTN may be rejected by the TGA if submitted with any of the following:
 Electronic signatures, all signatures on the CTN must be original wet ink signatures.
 Liquid paper is not acceptable on any part of the CTN.
 Any section of the document is not completed, signed, dated or the signees’ details
have not been inserted.
 If the start date listed on the CTN is well before the Approving Authority signature date.
For further information on CTNs and to access the most up to date version of the form please
visit the TGA website http://www.tga.gov.au/industry/clinical-trials.htm\
CTN guidelines
Version 2
14 March 2013