ResearchFest scientist


Project Amendment - External HREC Accepting Submissions

It is the responsibility of the Principal Investigator to ensure that all Post Approval requirements are met and that Lead HREC approval has been granted prior to Governance submission of Post Approval Applications.

All amendment submission must be include a HREC Amendment Form via ERM - Forms must have all sections completed in detail as instructed on the form.

A major amendment may include, but is not limited to:

  • Protocol Amendment (with or without a Participant Information & Consent Form (PICF) update, with/without a CTRA Addendum)
  • Substantial PICF update (addition of new or updated information)
  • Investigator Brochure (IB) update with a PICF and/or protocol update
  • Change of Principal Investigator
  • Addition of a site(s) - (An additional fee will be incurred for each site added - refer to payment form)

A minor amendment may include, but is not limited to:

  • Updated IB
  • Administration update to PICF (e.g. change of a phone number)
  • Addition of Associate Investigator^
  • Administration update to the protocol (e.g. change of sponsor contact details)
  • Updates to advertisement, participant material, questionnaires or Data Collection Forms
  • Request for extension of ethics approval
  • Change of research personnel
  • CTRA Addendums - without Protocol changes

Amendment Submission Requirements

HREC Amendment Form - Must be submitted with every Amendment

Amendment Payment Form

LEAD HREC Amendment Approval

Updated document with updated version numbers & dates – TRACKED

(Tracked documents should include all additions and changes to the text and strike through any deleted original text and highlight in bold or by underline any new text. Please use the 'Track Changes' option in MS WORD)

Updated document with updated version numbers & dates – CLEAN

Summary of changes in table format (Applicable only to protocol & IB amendments)

Change of Research Personnel Form (if applicable)

Austin Health Investigator Curriculum Vitae (if applicable)

Departmental Sign offs*

Updated Medical Physicist’s Report*

Updated/Amended Clinical Trial Research/Collaboration Agreement or Agreement Addendum**  (With coversheet and Authorisation Form) 

CTN, CTN Template Form and CTN Lodgement Fee Form (if applicable)

If you are unable to open any of these links in Internet Explorer, please try an alternative browser eg: FireFox or Google Chrome


* If your project utilises Pharmacy,PathologyRadiologyNuclear Medicine/PET Centre, Therapeutic Devices & Health Information Services and your amendment affects these department, a renewed departmental sign off will need to be obtained and submitted. Or if your amendment has updated radiation and you require and updated MPR please ensure this has sign off by the Medical Physics Department prior to submission of your amendment.

** If your amendment changes any condition of your original Clinical Trial Research/Collaboration Agreement (particularly relating to Schedule 2 - Budget) you will need to provide an updated agreement/addendum

Submit Amendment Via ERM - New Requirement

All amendments must now be submitted via the Ethics Research Management website.

        1. Please log into into the Ethics Research Management website

        2. Please collate the amendment application form and all of the necessary associated documentation.

 3.     Please submit one electronic copy with electronic signatures to 

 4.     Please note all supporting electronic documents must be labelled according to the following Naming [Please title the subject of the email "Amendment for [Austin Health Project Number & SERP/Protocol number (if applicable)]”

For immediate confirmation that your email has reached us, set up an automated 'Delivery Receipt Notification' before you send your email.

Notification of Associate Investigator Requirements

A change in Associate Investigator does not need lead HREC approval before being submitted to Austin Health.

The amendment will be processed at a site governance level only.