Amendments and Study Reports
The Last 2020 Submission Closing Date for Post Approval (e.g. Amendment & Study Reports): COB Thursday, 19 November 2020
COVID-19: Guidance for Researchers & Sponsors
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-Trials
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.
Other Important Information
All amendment applications (except addition of sites & change in CPI / PI), annual / final reports, safety reports and all other post-approval correspondence must be submitted via email as per the SCHN HREC submission guidelines described below. Amendment applications for addition of sites and change in CPIs / PIs must be submitted via REGIS, even for those applications previously approved via Online Forms.
Please read the following submission guidelines carefully before submitting your amendment applications / study reports and contact the Research Ethics Office if you have any questions.
Amendments to Existing Applications
Type of Amendment
Addition of Sites & change in Coordinating Principal Investigator (CPI) & Principal Investigator (PI)
All other amendment applications
Renewal of Ethics Approval
Researchers are required to submit an SCHN HREC Ethics Renewal Form when their project is anticipated to be completed within a period of greater than 12 months after their original ethics approval expiry date. If their project is to be completed within 12 months of their ethics approval expiry date, then an amendment application is sufficient to extend their approval for 12 months. Please contact the Research Ethics Office if you require any further information and/or assistance with the renewal of your ethics approval.
Annual / Final Reports
Annual Reports are due on the anniversary of the ethics approval.
Final Reports are due when the study is completed. A brief summary of findings should be attached.
Safety Monitoring and Reporting
Effective 1 November 2017, important changes were made to the safety monitoring and reporting requirements of research projects. These changes are consistent with the NHMRC's most recent guidance on safety monitoring and reporting in clinical trials involving therapeutic goods. SCHN Research Ethics and Governance Office has applied these reporting pathways to all types of research projects.
Please click on this link for more information and a detailed map of the new safety reporting pathways to the SCHN HREC: https://www.medicalresearch.nsw.gov.au/clinical-trial-safety-monitoring/
Please use these SCHN specific reporting form templates for the reports outlined in the above link:
All safety reporting must be submitted via email to SCHN-Ethics@health.nsw.gov.au.