Our organisation, the ethics committee and investigators must ensure that the research continues to conform to approved ethical standards, and in accordance with the Melbourne Health Research Policy.
I have Ethics and Governance approval, what now?
- Register participants on iPM as a research participant at the time they are first enrolled or consented.
- 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 Melbourne Health
Post approval submission of insurance certificates to the Office for Research is no longer a requirement.
Post Approval Management
- Post Approval Monitoring
- Adverse Events involving patients of Melbourne Health.
- Serious Breaches (Previously Protocol Deviation and Violation)
- Progress Reports are due annually by 31 March 2021
- 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 Melbourne Health.
- Amendments to the project approved by another Ethics Committee