Managing your project
After ethics approval and governance authorisation, researchers are required to report their progress and advise of any project changes.
All amendments and reports are submitted via ERM. Within the form there is an option to nominate which offices you are submitting to:
- Mater Human Research Ethics Committee (HREC) and Mater Research Governance Office
- If Mater HREC is the reviewing HREC, the form will be reviewed first by Mater HREC then forwarded to Mater Research Governance Office to review.
- Mater Research Governance Office – if an external HREC is the reviewing HREC
Amendments
Amendments to approved projects should include:
- summary of the amendment
- new documents
- amended documents (one tracked and one clean copy of each with a new version number and date in the footer)
Safety reporting
Unless otherwise stated in your approval/authorisation letter, for externally-sponsored clinical trials, Mater follows the National Health and Medical Research Council Guidance for safety monitoring and reporting for clinical trials involving therapeutic products.
Progress and final reports
Reviewing HREC | Mater annual report deadline | ERM form | Selection in form |
Mater Misericordiae Limited HREC | Anniversary of HREC approval | Mater Progress and Final Report Form | Both Mater HREC and Mater RGO |
External HREC | As per HREC reporting deadline | Mater Progress and Final Report Form | Mater RGO |
A final report is due on completion of your project or if the project is abandoned.
Onsite monitoring
Mater Research Governance Office monitors projects sponsored by Mater. This ensures projects are conducted in accordance with GCP, ethics approval and institutional requirements.