From time to time, Amendments to research projects are required. These are usually initiated by either the researchers or by external project sponsors. Amendments are required to be reviewed by our Governance Officers and authorized by Western Health as it may affect the research project at our site.
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. http://www.health.vic.gov.au/clinicaltrials/
Once approval has been granted for the Amendment by the reviewing HREC, please submit the following to Western Health Office for Research (if applicable):
All Amendment submissions must include the following:
HREC Amendment Form as submitted to the Reviewing HREC
All documents as listed on the Reviewing HRECs approval letter
Tracked and clean copies
Summary of changes if available
Statement of Approval Forms /SSA Head of Supporting Department sign off if any new department, resources or services are required
If Commercial study, Governance Protocol Amendment Fee with Compliant Tax Invoice
Submit electronic copy only
Tracked and clean copies of the Master PICF
Tracked and clean copies of the Western Health Site Specific PICF
Please ensure the following is on the Western Health Site Specific PICF:
Western Health logo, barcode & patient label
Western Health Principal Investigator/coordinator's names and contact details
Western Health Office for Research contact details for complaints
Western Health version number and date in footer & corresponding Master approved PICF version details should also be referenced in the footer.
If Commercial study, Governance Administrative Amendment fee with Compliant Tax Invoice
According to the NHMRC SAfety Monitoring and Reporting in Clinical Trials (November 2016), Investigator Brochure's are no longer required for WH Governance acknowledgement.
For Principal Investigator changes/additions:
Please provide all documents sent to the reviewing HREC
Acknowledgment letter from reviewing HREC
Curriculum vitae of new personnel using Western Health CV Template
If new personnel is an external researcher, they will need to complete an Honorary Researcher Appointment Form (includes Police Check Form, Pre-Employment Immunisation Form & Offline Applicant Form)
Submit electronic documents for the above and one hard copy of the original signed CV
For Associate Investigator and Study Coordinator changes/additions:
WH Change of Personnel Form
Curriculum vitae of new personnel using the Western Health CV Template
If new personnel is an external researcher, they will need to complete an Honorary Researcher Appointment Form (Include Police Check Form, Pre-Employment Immunisation Form & Offline Applicant Form)
Submit one hard copy and one electronic
Note: If adding more than one personnel, please note due to the limitation on our form we have created an attachment investigators details page for duplication. this is downloadable on the right hand side links.
Investigators should inform the Office for Research of when they commence and complete the project via email to [email protected].
Human Research Ethics Committees (HRECs) are required to monitor research in accordance with The National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research (2007). A condition of approval of all projects approved by a HREC is that a report of project progress is submitted annually by the Principal Investigator.
An Annual Progress Report should be submitted to the Reviewing HREC on the anniversary of the project's approval date.
In addition to submitting an Annual Progress Report, investigators are also required to submit a Final Report, due on completion of the study, or if the research is discontinued before the expected date of completion.
Researchers are required to forward the HREC Annual Report Form and the Reviewing HREC acknowledgment to Western Health Office for Research electronically via email at [email protected].
Governance Acknowledgment will be issued via email.
There is no need to submit external SUSARs/USADEs Line listings to the Office for Research.
SUSARs arising from Western Health site should be submitted for governance acknowledgement only. No HREC acknowledgement is required. Please send SUSAR listing to [email protected]
Governance acknowledgmentnt will be issued via email.