Clinical Trials

Quick Links

• ERM Guide - How to Create a LARF and Submit Post Approval Items
• Submission Requirements for Specific Amendments

The Australian Code for the Responsible Conduct of Research requires that institutions conducting research must have good institutional governance, ethical review, and management practices in place to encourage and monitor responsible conduct of research and promote research integrity.

The responsibilities of institutions for monitoring the conduct of approved research are also described in Chapters 3 and 5 of the National Statement, which states that;

"The granting and continuation of ethical approval of clinical research must be on the condition that, for any trial site under the HREC's responsibility, the researcher:

1. conducts the trial in compliance with the approved protocol
2. provides reports of the progress of the research, at least annually
3. informs the BH HREC, and seeks its approval, of amendments to the protocol, including amendments that:
   1. are proposed or undertaken in order to eliminate immediate risks to participants;
   2. may increase the risks to participants; or
   3. significantly affect the conduct of the research
4. notifies, in the manner and form specified by the HREC, any serious adverse events at any of those trial sites."

How to Submit an Amendment for Review

Barwon Health HREC amendments should be submitted as per the HREC Meeting & Submission Close Dates.

• Please submit all amendments via Ethics Review Manager (ERM) using the Amendment Request Sub-Form (if the research project is not on ERM, please follow the instructions within the ERM Guide at the top of this page)
• For funded projects, invoicing details should accompany the amendment - please see our Fees webpage
• To facilitate timely approval, please submit clean and tracked versions of all amended documents (including protocol changes, amended PICFs, etc.)
• If a project document is new (i.e. has not previoulsy been submitted to the BH HREC) this should be stated on the Amendment Request Form
• Please ensure that all documents are appropriately named - please see our Document Naming Guidelines.