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
Insurance certificates
Post approval submission of insurance certificates to the Office for Research is no longer a requirement.
Post Approval Management
- Post Approval Monitoring
- Amendments
- 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