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Clinical Trials and TGA requirements

Research projects conducted under the TGA Clinical Trial Notification (CTN) and Clinical Trial Exemption (CTX) schemes.

TGA Clinical Trial Notification (CTN) scheme

The CTN scheme transitioned from a paper-based system to electronic system on 1 July 2015.

The online CTN from can be accessed from the TGA Business Services website 

Eye and Ear site specific requirements

Submit the CTN form acknowledged by the TGA, when received, by email to the Research Office.
Research teams are expected to provide the TGA and Research Office with up to date information during the course of the trial. 

Site details

Site: The Royal Victorian Eye and Ear Hospital
Site address: 32 Gisborne Street, East Melbourne, Victoria, 3002

HREC name: The Royal Victorian Eye and Ear Hospital Human Research Ethics Committee
HREC code: EC00244
HREC contact officer: Ms Kerryn Baker
Position: Administrative Officer
Contact phone: 03 9929 8525
Contact email: ethics@eyeandear.org.au

Name of approving authority: The Royal Victorian Eye and Ear Hospital
Approving authority Contact Officer: Dr Sean Jespersen
Position: Executive Director Medical Services
Contact phone: 03 9929 8525
Contact email: ethics@eyeandear.org.au

Investigator Initiated studies
Where the Eye and Ear Hospital is the sponsor of the trial, the research team must contact the Research Office prior to submission.


TGA Clinical Trial Exemption (CTX) scheme

Paper based forms are accessed from the TGA CTX scheme forms website.

Eye and Ear site specific requirements

Part 1
Section 1.1 Sponsor of the trial
Where the Eye and Ear is the sponsor of the trial, the research team must contact the Research Office prior to submission.

Part 2
Section 1.1 Sponsor of the trial
Where the Eye and Ear is the sponsor of the trial, the research team must contact the Research Office prior to submission.

Section 1.5 Trial site details
Name of Institution: The Royal Victorian Eye and Ear Hospital
Address: 32 Gisborne Street, East Melbourne, Victoria, 3002

Section 1.6 Sponsor certification
For Investigator Initiated studies, the Research Office will organise Eye and Eye Hospital signatures.

Section 2 Principal Investigator
The Principal Investigator must sign Section 2 prior to submission to the Research Office.

Section 3 Human Research Ethics Committee responsible for monitoring the trial
Name: The Royal Victorian Eye and Ear Hospital Human Research Ethics Committee
Address: 32 Gisborne Street, East Melbourne, Victoria, 3002

The Research Office will organise HREC signatures.

Section 4 Authority approving conduct of the trial
The Research Office will organise Eye and Eye signatures.

Addition Eye and Ear information
For assistance with TGA CTN and CTX schemes, please contact the Research Office

Further information
Therapeutic Goods Administration Clinical Trials website 

 

Last updated 24 July 2019