Amendments to appoved and authorised research projects
Principal Investigator responsibilities
The Principal Investigator is responsible for:
- notifying the Western Health Office for Research of any changes to an authorised higher risk or multi-site SSA project
- notifying the Western Health Low Risk Ethics Panel (LREP) of any changes to a low-risk project approved by the LREP
- notifying the Office for Research of any changes to an authorised QA/MRR project
- seeking approval/authorisation of the change before implementing any changes.
How to submit an amendment
All amendments for projects must be submitted via the Ethics Review Manager (ERM):
WH only site – Low risk project approved by WH LREP
- Go to your project in ERM.
- The sub form you create will depend on the main ethics application form type approved:
- For HREA form – create an ethics amendment form.
- For LR VIC Form – create a Low-Risk Notification sub-form.
- Select Amendment (for purpose of report)
- Complete all fields (write “N/A” if not applicable)
- Upload your updated documents and submit the form.
Multi-site – Low risk and higher risk research project
- Go to the project in ERM.
- Create the relevant post approval sub form to the main ethics form which will be either a HREA form or the VIC LR Form.
- Upload your updated documents and submit the form.
Important: Changes to QA/MRR projects is done in ERM via the Correspond Action tab and uploading of the requisite Western Health generic QA/MRR post approval form.
See below for detailed documentation requirements for specific amendment types.
Mandatory file naming convention
To ensure your documents are accepted and easy to track, you must name them correctly and include version numbers and dates. For more information on naming files, see our Electronic Naming Convention guidelines.
Documentation required for specific amendment types
Protocol amendment
- Submit a Project Notification Form (sub-form in ERM).
- Upload tracked and clean versions of the updated Protocol.
- Ensure version names and dates are updated.
- Include a Summary of Changes (if available).
- Pay application fee (if applicable) – see fee schedule page for details.
- If changes increase number of tests, visits or costs:
- Upload updated approval statement from relevant service departments.
- Submit amend MOU or Research Collaboration Agreement (3 signed copies) – see Research Agreements page for review process.
- If changes affect the PICF, follow the requirements directly below.
PICF (Participant Information and Consent Form) amendment
- Submit a Project Notification Form (sub-form in ERM).
- Upload tracked and clean versions of the revised PICF.
- Ensure version numbers and dates are updated.
Change of personnel
- Notify the Office for Research via a Project Notification Form (ERM sub-form).
- For new researchers, include:
- CV using the WH template
- Signed WH Research Code of Conduct Declaration (2023) if not received in last 2 years.
- For a new Principal Investigator, also include:
- Current GCP Certificate (within last 3 years).
- For external personnel:
- Apply for an Honorary Research Appointment (see Honorary Appointments page for details).
Serious or suspected breach
- A serious breach is any violation of Good Clinical Practice (GCP) or the protocol that significantly impacts participants safety or data reliability.
- A suspected breach is a possible serious breach not yet confirmed by the sponsor.
- All breaches must be reported directly to the Low Risk Ethics Panel (LREP).
- Submit using the Project Notification sub-form in ERM and select “Serious/Suspected Breach” as the category.
Significant Safety Issue (SSI)
- Western Health is required to comply with 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.
- Report all SSIs as soon as possible (preferably within 24 hours).
- Submit via a Project Notification sub-form in ERM and select “Safety Report” as the category.
Other document changes
- Submit a Project Notification Form (sub-form in ERM).
- Upload tracked and clean versions of updated documents.
- Ensure all documents include revised version numbers and dates.