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 Research Policy.
I have Ethics and Governance approval, what now?
- Ensure that participants (including health volunteers) are registered with HIS and have a UR number. Visit the HIS webpage for more information.
- Notify the Office for Research of the actual start date of the project at Royal Melbourne Hospital (RMH).
Post approval submission of insurance certificates to the Office for Research is no longer a requirement.
Post Approval Management
- Post Approval Monitoring
- Safety and Adverse Events involving patients of RMH, Data and Safety Monitoring Board (DSMB) and Annual Safety Reports
- Serious Breaches (Previously Protocol Deviation and Violation)
- Annual Progress Reports are due by 31 March each year
- Final Report upon completion of the project
- Correspondence which may include:
- Unforeseen events
- Any matters not covered elsewhere which may impact on the conduct of the project at RMH
- Amendments to the project approved by another Ethics Committee