Amendments and Study Reports

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

Submission process

Addition of Sites & change in Coordinating Principal Investigator (CPI) & Principal Investigator (PI)

  • Please submit your amendment application via REGIS and as per the REGIS Quick Reference Guide “Ethics Amendment - Completing and Submitting” available on the REGIS website.

All other amendment applications

 

  • Complete Amendment Application Form.
  • Email the completed application form plus supporting documentation to SCHN-ethics@health.nsw.gov.au.
  • Principal Investigator should be copied into the submission email.
  • Submissions should be from a valid organisational email address.
  • Both tracked and clean copies of updated documents should be provided. If track change is not possible, changes to the documents should be highlighted.
  • Please ensure that the version numbers and dates of amended documents are updated

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. 

Completed SCHN HREC Ethics Renewal Form and supporting documentation should be emailed to SCHN-ethics@health.nsw.gov.au.

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.

Completed Annual / Final Report Form should be emailed to SCHN-Ethics@health.nsw.gov.au.

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.