Multi-site Post Approval Amendments
Please Note: We have set a final closing date for Post approval submissions for the year 2024 to allow for the submissions received and in process by this date to be finalised before the end of 2024. The last day for submissions to receive is Friday 13 December 2024 and is open to applications on Monday 27 January 2025.
What if my matter is URGENT?
Only post approval submission impacting patient safety or identified as urgent by the Office for Research will be reviewed during the closure period.
Researchers are asked to contact the Office for Research in person or via telephone 03 8395 8070 or email [email protected] to ensure that urgent matters are brought to the attention of the appropriate team member so they can be reviewed and actioned in a timely manner.
The Coordinating Principal Investigator (CPI) at the lead site is responsible for submitting an Amendment request to the reviewing Human Research Ethics Committee (HREC) for approval.
How to Submit an Amendment for Review
- See ERM Post Authorisation Submission Process Map (download document from right hand side links)
- Please complete and submit all amendments via Ethical Review Manager (ERM) using the Site Governance Amendment
Request Sub-Form and send an email notification to [email protected] to initiate review. The email must include the following details:
- ERM Project ID & HREC Reference number
- Project title
- Type of Amendment
Note: See the WH ERM Post Authorisation Submissions Guide for further ERM Submission details (download document from right hand side links).
- All Amendment Submissions must include the following (these should be uploaded as supporting documents with the ERM Site Sub Form);
- HREC Amendment Request Form (as submitted to the reviewing HREC)
- HREC Approval/Acknowledgment letter/email/stamp
- All documents as listed in the reviewing HREC approval letter/email
- Submission of any WH sites specific amendments based on the master HREC approved documents e.g. Participant Information and Consent Form (PICF), advertisements, letterheads etc.
- Application Fee (where applicable)
- To facilitate timely approval, please submit clean and tracked versions of all amended documents (including protocol changes, amended PICFs, etc.)
- Please ensure that all documents are appropriately named - see our Mandatory electronic file name convention:(download right hand side)
- 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: [Ethics reference/ERM Project ID] [Document Name] [version number] [Date DDMMMYY]
E.g. 41234 Protocol v1 01Jan19; HREC18MH123 PICF Master v3 01Jan18
CVs, GCP & Codes (where applicable) to be named as:
- [First Name][Last Name] WH CV DDMMMYY
- [First Name][Last Name] GCP DDMMMYY
- [First Name][Last Name] WH Code DDMMMYY
Documentation required for specific amendment types
| | Type | Requirements |
| 1 | Protocol Amendment | Tracked and clean versions of the Protocol. Summary of Changes if available. If changes increase number of test, visits or costs: Updated Statement of approval from relevant departments CTRA Amendment (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 | Tracked and clean versions of the Master PICFs required. Tracked and clean version of the Western Health Site Specific PICFs required. Ensure version numbers and dates are correct. |
| 3 | Investigator's Brochure | According to the NHMRC Safety Monitoring and Reporting in Clinical Trials (November 2016), Investigator's Brochures are no longer required for WH Governance acknowledgement. |
| 4 | Change of Personnel | Principal Investigator Changes: - Principal Investigator (PI) changes require approval from the reviewing HREC.
- Provide all forms as submitted to the HREC
- HREC acknowledgement letter/email approving PI change.
- 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, please attach a GCP completion certificate (training completed within 3 years)
- Revised documents to revised PI name in relevant documents e.g. PICF, Advertisements, and Letters of Invitation etc.
Associate Investigator, Study Coordinator, Student Researcher, Contact person changes: These personnel changes do not require approval from the reviewing HREC. - WH Change of Personnel Form
- 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, please attach a GCP completion certificate (training completed within 3 years)
- If the new personnel will be involved in consenting patients, please add investigator to the WH Site Specific PICF for authorisation, tracked & clean copies with updated version numbers and dates are required.
- If the new personnel are an external researcher, an Honorary Researcher Appointment may be required. Please see the Honorary Researcher page.
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| 5 | External Monitors for Commercial Projects | No Amendment and no HREC approval is required. External monitors are required to complete and sign the Approval to Examine Medical Records Form. Please refer to relevant documents (right hand side) to set up network access and EMR WeLearn training for external monitors. |
| 6 | Insurance Certificate | No Amendment and no HREC approval is required. Please forward a copy of the updated Insurance Certificate/Certificate of Currency. Please ensure that the updated insurance certificate contain the VMIA minimum insurance requirements: - Detail the type of insurance - Public and Product Liability - or equivalent such as General Liability or Clinical Trials Insurance
- Include as a named insured the full, legal name of the Australian entity acting as a sponsor
- Detail the period of insurance
- Provide insurance coverage for a minimum of $10million AUD for any one occurrence and in the annual aggregate
- Not contain an excess/deductible, or self-insured retention amount greater than $25,000 AUD for each and every claim or series of claims arising out of the one original case.
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| 7 | Approved documents | Provide all documents as listed in the HREC approval letter/email. |
