• Ethical Review Manager (ERM) (New Governance/Ethics Submissions, formerly Online Forms)
  • For ERM assistance please refer to https://www.clinicaltrialsandresearch.vic.gov.au/ethical-review-manager where you will find help, training and a copy of the Application User Guide which will take you through ERM including:
    • Creation of New ERM Accounts (Section 1)
    • New and Post Approval Submissions
    • Legacy Application Replacement Form (LARF – For studies not already registered on ERM) Section 12). Essentially all studies are, or will need, to be registered on ERM
    • Progress Reporting (Section 15)
  • Annual and Final Reporting of research is to be submitted via ERM only, previous forms are now obsolete and cannot be accepted. Assistance with reporting can be found within Section 15 of the Applicant User Guide.
  • The Eastern Health Office of Research and Ethics are users of ERM, as applicants are, we are not the developers, owners or control ERM, so any technical or user issues, need to be to directed here Ethical Review Manager – Clinical Trials and Research under ERM Help. This includes, but is not limited to (a) Signing up to ERM (b) Unable to access (c) “I can’t see my project” etc. Our office cannot see anything during the actual application process, only once it is submitted.

These fees are for EH Research/Ethics/Governance only and they are unrelated to Site, Start Up, Pharmacy, Patient fees etc. These fees are for review, and not for approval, please refer to the correct section of CTRA where applicable. Our fees are not specifically listed in a Clinical Research Trial Agreements (CTRA’s), they will be referenced in a section referring to this webpage. Overdue fees will incur sanctions on the research and potentially other research related to the sponsor and/or research group.

Change of Fee structure will commence form 1 July 2024.

These changes related to Patient Information Consent Forms and CTRA Amendments.

From this date, the below new Fee Notification Forms (FNA) must be used, there will now be 2 forms, one for new submissions and another for subsequent Post Approval actions. Use of obsolete forms will be returned after this date.

FNA New Study July 24 (DOC,61KB)

FNA Post Approval July 24 (DOC,64KB)

Please note all Low and Negligible Risk Applications are now to be submitted via Ethical Review Manager (ERM) only. Please refer to ERM directions above, Obsolete forms will be returned

(All relevant documents are to be submitted to [email protected])