Our organisation, the ethics committee and investigators must ensure that the research continues to conform to approved ethical standards, and in accordance with the Royal Melbourne Hospital (RMH) Research Policy throughout its lifecycle.
Post-Approval Reporting
There is no specific time frame for general post-approval reporting. Post-approval correspondence will be processed as soon as possible after it is received.
Post-approval correspondence requiring HREC review will be forwarded to the relevant spokesperson upon initial Office for Research review with approval often provided out-of-session.
Where post-approval reports require review by the full HREC, this will be communicated to the project Point of Contact and Principal Investigator.
Annual Site and Project Progress Reports
These reports are due annually on 31 March for all RMH HREC and SSA-approved projects.
The RMH as Sponsor for Investigator-Initiated Studies
Serious Adverse Events (SAEs) are reportable to the RMH as Sponsor. The SAE form is available on the intranet and must be submitted within 24 hours of being made aware of the event.
In this section
From time to time, amendments to research projects are required often due to protocol changes, updated investigator brochures, personnel changes on the study, site additions, and more. Researchers and sponsors must notify the HREC of such changes.
Find out moreReporting to the Research Office is a condition of ongoing ethics approval.
Find out moreMaintaining and reporting of adverse events and safety information in research will ensure that RMH complies with the NHMRC's National Statement.
Find out moreSerious Breach is a breach of Good Clinical Practice or the protocol that is likely to affect to a significant degree the safety or rights of a research participant or the reliability and robustness of the data generated in the research project.
Find out moreThe Royal Melbourne Hospital is required to monitor all approved research until the completion of the project.
Find out moreInternal audit of research is an important means by which the Royal Melbourne Hospital ensures research auspices is conducted in accordance with good clinical practice (GCP) and approved ethical guidelines
Find out moreCorrespondence
Contact the Ethics team at the RMH where:
- Unforeseen events have occurred, or
- Any other matters not covered elsewhere that may impact on the conduct of the project at the RMH
In these instances, provide details (including the local project number) and submit them to ResSafety@mh.org.au