Research

Project Amendment

This type of application applies when post-approval changes are required. A project amendment may be considered to be major or minor.

All amendment submission must be include a HREC Amendment Form - 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) (this will also incur and an additional site fee of $220 including GST per site) 

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

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)

Waiver of Consent Request Form (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  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

Submitting your amendment:

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

2.     Please submit one electronic copy with electronic signatures to ethics@austin.org.au 

3.     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

When a participating site (for which Austin Health are the lead HREC) has changed associate investigators at a site governance level, please notify the Austin Health HREC of this change by submitting a copy of the participating sites, addition of investigator approval letter. This will be acknowledged by email only (not approved).

Please note that the participating site does not need Austin Health HREC approval for the addition of  associate investigators.