LR Post Approval Submission Requirements
The Principal Investigator is responsible for advising the Western Health Low Risk Ethics Panel regarding any changes and updates and seeking approval before implementation.
All LR Amendment Submissions are to be submitted via Ethics Review Manager (ERM) through creation of the Project Notification sub-form to the LR Vic Form for the project.
Mandatory Electronic file name convention:
To ensure the electronic copies submitted are easily identifiable, the format outlined below must be used for all electronic files. As shown in example below, include version numbers and dates in the file name.
Projects submitted with documents that do not follow the below naming convention/format will not be considered and will be returned via email to sender.
Convention: [ERM Project ID] [Document Name] [version number] [Date DDMMMYY]
E.g. 41234 Protocol v1 01Jan19
See electronic naming convention document (download on right hand side links) for more details.
Documentation required for specific amendment types
| | Type | Requirements |
| 1 | Protocol Amendment | Project Notification Form (Ethics Review Manager) sub form creation
Tracked and clean versions of the Protocol, ensure version numbers and dates are revised Summary of Changes if available. Application Fee if applicable. If changes increase number of test, visits or costs: Updated Statement of approval from relevant service departments impacted. MOU/Research Collaboration Agreement Amendment (3 x original signed) See Research Agreements Page for review and endorsement requirements. If changes warrant changes to the PICF, please see point 2 for PICF amendment requirements. |
| 2 | PICF Amendment | Project Notification Form ( Ethics Review Manager) sub form creation Tracked and clean versions of the revised PICF Ensure version numbers and dates are revised |
| 3 | Change of Personnel | The Office for Research should be notified for any changes or additions of new personnel. An Project Notification form ( Ethics Review Manager) sub form creation, and please include; Curriculum Vitae using the WH CV Template and signed WH Research Code of Conduct (2023) Declaration for new researchers (if not received in last 2 years) GCP training is mandatory for Principal Investigators, please attach a GCP completion certificate (must be within 3 years) if there is a PPI change. Any external personnel would be required to obtain an Honorary Appointment. Please see Honorary Research Appointment page (link on right hand side) for submission information for Honorary Applicants. |
| 5 | Serious Breach/Suspected Breach Reporting | A serious breach is a breach of Good Clinical Practice ( GCP) or the protocol (any change, divergence, or departure from the study design or procedures of a research protocol) that is likely to affect to a significant degree the safety or rights of a research partcipant or the reliability and robustness of the data generated in the research project. A suspected breach is a report that is judged by the reporter as a possible serious breach but has yet to be formally confirmed as a serious breach by the sponsor.
A suspected breach notification must be completed when a third party (e.g. individual or institution) wishes to report a suspected breach of Good Clinical Practice (GCP) or the protocol. This should be reported directly to the LREP without reporting through the sponsor.
Western Health Low Risk Ethics Panel requires the reporting of all serious/suspected breaches of GCP orserious/suspected breaches from the approved research protocol.
Create the Project Notification sub-form to the LR VIC- to report Serious breach or suspected breach |
| 6 | Significant Safety Issue (SSI) Report | Western Health is required to comply with the requirements of the NHMRC National Statement on Ethical Conduct in Human Research (2023), the Australian Therapeutic Goods Administration and the Victorian Managed Insurance Authority, maintaining and reporting of adverse events and safety information in clinical research. Submit all safety issues as soon as possible (ideally within 24 hours). Create a Project notification sub-form on ERM and select as the category safety report and submit on ERM. |
