CTN & Trial Rego

The CTN and CTA schemes provide the avenue for importation into and/or supply of ‘unapproved’ therapeutic goods for use in clinical trials.

Unapproved therapeutic goods include:

•            Any medicine, device or biological not included in the Australian Register of Therapeutic Goods (ARTG)

•            Any therapeutic good included in the ARTG but used in a manner not covered by the existing entry

For more information on what CTN and CTAs are, see CRDO website Approvals & Registration. 

How to apply for a CTN/CTA

Please submit the Clinical Trials Notification request form if you need to organise a CTN. You should anticipate a minimum of 2-3 weeks for your CTN to be fully processed.

To make CTN variations, please submit the CTN Variation submission form. A CTN variation is necessary for any changes to the study such as changes in Site PI, changes in expected trial completion dates, new sites added, additional medications or changes to medicine administration etc.

For further information about CTN requirements and how to organise a CTN for a MCRI-sponsored trial, see the Melbourne Children’s Standard Operating Procedure, MCTC048 SOP Submitting and updating a CTN to the TGA. For guidance on the legislative, regulator and GCP requirements for conducting trials under a CTN or CTA, see the TGA’s Australian Clinical Trial Handbook.

Registration of trials in a publicly accessible trial registry is universally regarded as good research practice.  The World Health Organization (WHO) considers registration to be “a scientific, ethical and moral responsibility”.

How to register your study through MCRI

All MCRI-sponsored trials must be registered with ClinicalTrials.gov (CT.gov). The Sponsor-Investigator is responsible for ensuring the trial is registered before the first participant is consented.

MCTC is responsible for supporting Sponsor-Investigators to register their trial with CT.gov and maintain their record in accordance with CT.gov requirements. 

To initiate registration, the Sponsor-Investigator will need to email [email protected] to apply for a PRS User account.  The drafting and review of trial registration records takes time.  Please commence the trial registration process once you have a final protocol and at least three weeks before you plan to commence recruitment.

For further information about clinical trial registration requirements and how to register an MCRI-sponsored trial, see the Melbourne Children’s Standard Operating Procedure,  MCTC026 SOP Clinical Trial Registration of Investigator-Initiated Trials (IITs).