Research governance news and updates

 Upcoming Good Clinical Practice Training (GCP)

SCHN Research Governance invites you to

an interactive training session on

Good Clinical Practice and the Regulatory Requirements for Clinical Trials for Clinician/Allied Health Investigators and Study Coordinators

Current, valid GCP Accreditation is required for all investigators conducting clinical trials. Four (4) sessions are available and have been split into Refresher and New Researcher specifically designed for time-pressed investigators and study coordinators.

Each session is interactive, transcelerate accredited and you will receive a certificate valid for 3 years that is accepted by sites and Industry. Further information will be sent following registration. Each session can accommodate 30 participants.

Sessions will be held online over Zoom on:

  • Wednesday 26th October 2022: 1:00pm – 3:00pm NEW STAFF
  • Thursday 27th October 2022: 4:00pm – 5:30pm REFRESHER
  • Monday 7th November 2022: 4:00pm - 5.30pm REFRESHER
  • Tuesday 8th November 2022: 1:00pm – 3:00pm NEW STAFF

Please register here by sending an email to:

SCHN-Governance@health.nsw.gov.au this must be from your institutional email and include both your first and last names so we can contact you with the session zoom links and pre-reading details.


Contact details

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

Phone: 02 9845 3011

 Research Governance Office Newsletter

Research Governance Newsletter 2022.03.10 

 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.