CTN Scheme

a) When is a CTN required?

A trial of any medicine or device* not entered on the Australian Register of Therapeutic Goods (ARTG) including any new formulation of an existing product or any new route of administration must be conducted under the Therapeutic Goods Administration's (TGA) Clinical Trial Notification (CTN) Scheme.

A placebo is also considered to be an 'unapproved therapeutic good and a CTN or CTA must be in place before a placebo can be supplied for use in a clinical trial (this includes the use of 'sham' devices).

*A medical device can be any product or software (including AI) that works to achieve a therapeutic purpose in or on human beings (https://www.tga.gov.au/products/medical-devices)

All CTN Scheme Forms must be submitted using the online form. Guidance is available on the TGA website.

It is the responsibility of the clinical trial Sponsor to complete and lodge the CTN via the TGA Business Services (TBS) website.

External sponsors should not submit an online CTN until written HREC approval has been received.

External sponsors should add each site to the online CTN’s “trial site details” only after receiving written site authorisation.

A copy of the TGA acknowledgement of receipt of a CTN should be submitted in REGIS as soon as it is available, for inclusion on the study file.

b) Investigator initiated clinical trials (no external sponsor):

These are clinical trials where Sydney Local Health District (SLHD) acts as the sponsor. During the review of the Site Specific Authorisation (SSA) application, the researcher will be asked to complete a CTN information form so that lodgement of the CTN may be completed by the Research Office staff on behalf of the research team. This will ensure that the sponsor details are entered correctly for insurance purposes and will provide researchers support in complying with the TGA requirements. Payment of the CTN can also be made at this time. Local investigators should not set up their own TBS account.

A revision to the CTN is required where there are changes to the clinical trial. These changes include but are not limited to:
• revision to study drug/dose/administration/manufacturer
• extended trial completion date
• change of Principal Investigator
• addition of site

The Research Office staff will submit the CTN revision on behalf of the research team. The investigators should contact the Research Office to determine whether a CTN revision is required.

CTN Information Form Link: https://redcap.slhd.nsw.gov.au/surveys/?s=8TK4WHDCAWJTM3MH