Researchers are required to notify Research Support Services, in writing, if there are any amendments required to the research protocol after approval by the HREC.
All amendments are to be emailed to firstname.lastname@example.org
The email title must contain ‘Post-Approval Amendment’ and the Local Monash Health Reference Number eg: Monash Health Ref: 18-0000-100A.
Information submitted should contain the following:
- a covering letter from the principal investigator
- Amendment Form summarising the amendments and commenting on the implications of the amendment to the project and whether the changes warrant any revisions to the Participant Information and Consent Form. The Consultative Council for Clinical Trial Research Amendment Form needs to be downloaded and completed: https://www2.health.vic.gov.au/about/clinical-trials-and-research/clinical-trial-research/monitoring-reporting
- A document detailing the changes made, including all additions and changes to the text and strike through any deleted original text and highlight in bold or by underline any new text. A new version number and date is required in the footer of each page of any revised Patient Information Sheet.
These Amendments will be considered by the Medical Administrator to HREC & Governance, and research in the amended form should only proceed after written approval is received, usually within 5 working days of submission. In certain circumstances, the Medical Administrator will refer Protocol Amendments to the full HREC for consideration. In this instance, researchers will be informed that the HREC will be considering the Protocol Amendment.