a) When is a CTN required?
A trial of any medicine or device (or its software) 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 CTN Scheme.
On 1 July 2015, the Therapeutic Goods Administration (TGA) launched the electronic clinical trial notification (CTN) scheme (Notification of Intent to Supply Unapproved Therapeutic Goods under the Clinical Trial Notification Scheme), which replaced the paper-based notification form.
All CTNs 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 sent to the RPA Research Office 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. Upon receipt of the letter of Site Specific Authorisation, the researcher will be asked to make an appointment with the RPAH Research Office so that lodgement of the CTN may be completed by both the investigator and Research Office staff. 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.