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.
Please see the Department of Health website for more information on forms and process in submitting to the reviewing HREC or the reviewing HREC website for their submission requirements.
All Amendment Submissions must include the following:
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 (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.
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
Principal Investigator (PI) changes require approval from the reviewing HREC
Provide all forms as submitted to the HREC and their acknowledgement.
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, please attach a GCP completion certificate (must be within 3 years)
Revised documents to revised PI name in relevant documents e.g. PICF, Advertisements, Letters of Invitation etc
These personnel changes do not require approval from the reviewing HREC.
WH Change of Personnel Form
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.
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 $10millionAUD 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.
Applicants must submit the ethics application email [email protected]
Submitting amendments via Online Forms & ERM only is not considered a formal submission and will not be processed.
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.
Please do not use the following symbols in your electronic filename: ! @ $ % &
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.