Research governance news and updates

Contact details

Email: SCHN-Governance@health.nsw.gov.au

Phone: 02 9845 3011

We encourage you to book a pre-submission meeting for any new LNR project you are planning to submit.

LNR applications submitted after 1st March without a pre-submission meeting will be rejected.

Research Governance Office Newsletter

Research Governance Newsletter Nov 2022

 COVID-19: Guidance for Researchers & Sponsors

Dear SCHN Research Community,

Please find below guidance from the NSW Office for Health and Medical Research (OHMR) and the Commonwealth Department of Health for conducting clinical trials and other relevant clinical research affected by the COVID-19 situation.

NSW OHMR Guidance: https://www.medicalresearch.nsw.gov.au/covid-19-clinical-trial-guidance/

The Commonwealth Department of Health Guidance: https://www1.health.gov.au/internet/main/publishing.nsf/Content/Clinical...

Please note that the SCHN Research Ethics and Research Governance Offices will operate based on these guidelines.

Please also note that we are prioritising applications and correspondence related to COVID-19 that are critical to patient safety. We endeavour to manage all other applications and correspondence as per standard timelines; however there may be some delays depending on volume.

Thank you for your patience and understanding.

Contact details for enquiries
SCHN Research Ethics: SCHN-ethics@health.nsw.gov.au
SCHN Research Governance: SCHN-Governance@health.nsw.gov.au

Kind Regards,
The SCHN Research Ethics and Governance teams

TGA changed the name of the Clinical Trial Exemption (CTX) scheme to the Clinical Trial Approval (CTA) scheme.

The change in terminology from CTX to CTA more accurately reflects the nature of the scheme under the Therapeutic Goods Act 1989, which involves sponsors applying for the TGA’s approval to supply unapproved therapeutic goods in Australia via a clinical trial despite the therapeutic goods not being entered in the Australian Register of Therapeutic Goods (ARTG). The scheme’s previous name of CTX underscored the exemption given by the TGA to a sponsor from entering their therapeutic good in the ARTG before conducting a clinical trial.

The TGA website has been updated to reflect the name change, and we are also asking our stakeholders to update their documentation to replace CTX with CTA. Read our news item to learn more.