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 QA/LNR Amendment Submissions are to be submitted electronically to [email protected]
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 | WH LREP Amendment Request Form or Amendment Request Form (Ethics Review Manager)
Tracked and clean versions of the Protocol, ensure version numbers and dates are revised Summary of Changes if available. If changes have any privacy implications, researchers will need to complete Section 2 of the Victorian Specific Module. 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 | WH LREP Amendment Form 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. A WH Change of Personnel should be completed; Curriculum Vitae using the WH CV Template and signed WH Research Code of Conduct (2018) 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) Note: Due to limitations on our form to add more fields – if researchers are adding more than one investigator, please complete this duplication page with their details:  Attachment_WH Investigator Details Page |
| 5 | Protocol Deviation/Violation Reporting | A protocol violation is any change, divergence, or departure from the study design or procedures of a research protocol that affects the participant's rights, safety, or wellbeing and/or the completeness, accuracy and reliability of the study data. Western Health Low Risk Ethics Panel requires the reporting of all deviations and violations from the approved research protocol |
| 6 | AE/SAE Report | Western Health is required to comply with the requirements of the NHMRC National Statement on Ethical Conduct in Human Research (2007), 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 AE/ SAEs as soon as possible (ideally within 24 hours). |
