Safety Reporting
All safety reporting must be submitted via ERM, by creating a sub-form under the relevant project and application form. See guideline for further information.
Amendment Submissions
You must advise the HREC and RGO if you plan to change your study in a way that could affect the ethical or ongoing site acceptability.
You'll need to submit your report online by creating a sub-form in the Ethics Review Manager (ERM).
Make sure you select Post Authorisation Notification Form – RGO when you create the sub-form. You’ll need to create a separate sub-form for each notification.
Your submission should include:
- rationale and summary of the amendment from the principal investigator - to be completed in the ERM amendment form
- a copy of all additional and amended documents - one tracked and one clean copy of each revised document including a new version number and date in the footer
- a copy of the HREC amendment approval letter.
You can find submission instructions here.
Reporting requirements
If your research has been given ethics approval and governance authorisation you’ll have reporting requirements.
- Fill in the commencement form when you begin your research
- Submit a copy of the annual report with your HREC approval letter for any studies approved by the non-CHQ HREC
- Submit a copy of the final report with a copy of the HREC approval letter in ERM
You can find the submission instructions here.