From 01 January 2019, all new submissions for Human Research Ethics and Governance Review and all post-approval amendments will be electronic.
- Researchers are asked to lodge both new submissions and post-approval amendments via ERM https://au.forms.ethicalreviewmanager.com/Account/Login
- Following lodging the submission/post-approval amendment – please send a courtesy email to firstname.lastname@example.org informing the team of the new submission or the post-approval amendment.
- In the email please advise of the ERM Reference and Monash Health Reference (if one has already been assigned) along with the study title.
- The only documents required in hard copy, will be Research Agreements and Indemnities as many commercial sponsors prefer a wet ink signature.
The post-approval information should contain the following information:
- a covering letter/email 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.