Therapeutic Goods Administration Clinical Trial Notification (CTN)

The Australian clinical trial sponsor must notify of the intent to sponsor a clinical trial involving an 'unapproved' therapeutic good. This must take place before starting to use the goods. The notification form must be submitted and accompanied by the relevant fee.

From 1 July 2015, the Therapeutic Goods Administration (TGA) transitioned to an online system for CTN submission.

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.

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

Please note:

• 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 is to be uploaded to REGIS for HNE Research Office Acknowledgement via REGIS site amendment BEFORE recruitment starts onsite.

Reviewed by the Hunter New England Human Research Ethics Committee (HREC):

The following information is provided to assist with the registration of clinical trials that have been reviewed by the Hunter New England Human Research Ethics Committee (HREC).

Clinical Trail’s being conducted in Hunter New England Local Health District facilities:

The following information is provided to assist with the registration of clinical trials being conducted within HNELHD facilities.

Clinical Trials being conducted in Hunter New England Local Health District facilities with HNELHD as study sponsor:

The following information is provided to assist identify the circumstances where HNELHD should act as a sponsor:

• Where the organisation co-ordinating the trial is an overseas entity, for example the Children’s Oncology Group trials.
• Where an investigator led study within NSW Health requires the Local Health District to act as the study sponsor on their behalf.
• Where a HNELHD staff member is the Investigator but cannot take on the role of the Sponsor – for example if a clinical trial agreement is required because a pharmaceutical company is providing the trial medication and is requesting access to the study data in return

CTN lodgement to the TGA will occur by the HNE Research office for all HNELHD Investigator initiated projects or HNELHD sponsored trials.

For this to occur, the below application form should be submitted with the initial Site Specific Application in REGIS

• HNELHD CTN Application form

Once the CTN application form has been submitted, an invoice will be forwarded to the Principal Investigator for payment.

If No payment is made, the application will become void and a TGA breach may occur.

CTN Variations:
All future changes will require the Principal Investigator to submit a CTN variation to the TGA outlining the details of this change.

The following variations to a previously notified trial will incur a fee:

• Addition of new site(s) to a previously notified trial
• Change to previously notified therapeutic goods that creates separate and distinct goods
• Addition of a new therapeutic good to a previously notified trial

For variations of HNE sponsored, the below application form should be submitted via a Site Specific Amendment form in REGIS

• HNELHD CTN Application form 

Once the CTN application form has been submitted, an invoice will be forwarded to the Principal Investigator for payment.

If No payment is made, the application will become void and a TGA breach may occur.

If your variation is urgent, please email: HNELHD-ResearchOffice@health.nsw.gov.au