Safety Reporting
All safety reporting must be submitted via ERM, by creating a sub-form under the relevant project and application form. Refer to the Safety Reporting for Clinical Trials procedure [PDF 578.93 KB] for more 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.
Refer to the amendment submission instructions [PDF 160.61 KB] for more information.
Reporting requirements
If your research has been given ethics approval and governance authorisation you’ll have reporting requirements.
- Fill in the commencement form [DOCX 235.4 KB] 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
Refer to the annual/final report submission instructions [PDF 311.89 KB] for more information.