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.

1. Fill in the commencement form when you begin your research
2. Submit a copy of the annual report with your HREC approval letter for any studies approved by the non-CHQ HREC
3. Submit a copy of the final report with a copy of the HREC approval letter in ERM

You can find the submission instructions here.