The justification for the amendment and a detailed explanation of the amendment is required. If insufficient details are provided, the amendment will not be reviewed. A tracked (showing all deletions and additions/changes) and a clean copy of all amended documents must be submitted.
Single Site Ethical Review Projects:
- The Principal Investigator (PI) is responsible for submitting the amendment for ethical review. The Principal Investigator will be advised of the outcome of the review and any further queries or requirements
- Note: the amendment will undergo Governance Review in parallel with the Ethical Review. If the amendment impacts the type or frequency of service provided by any of our supporting departments, a Supporting Department form/s will also be required
Multisite Ethical Review Projects:
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The Coordinating Principal Investigator (CPI) is responsible for submitting the amendment for ethical review on behalf of all participating sites. The Coordinating Principal Investigator will be advised of the outcome of the review and any further queries or requirements
Submission due dates
See Submission and Meeting Dates for upcoming amendment submission dates.
Preparing your amendment application
Required documents
- Completed and signed HREC (Human Research Ethics Committee) Amendment Form. The form is created and submitted in ERM (Ethics Review Manager) as a sub form of the project HREA (Human Research Ethics Application). If your project does not have an ERM account, please complete the form found in ‘Useful resources, training, and forms.’
- Clean and tracked versions of amended project documents – for example, Protocol, PICF (Participant Information and Consent Form), Investigator Brochure
- Any newly added project documents
- Amended or New CTN (Clinical Trial Notification) if required. Please see the TGA (Therapeutic Goods Administration) CTN scheme site for advice on how notify the TGA of changes to the CTN
- Amended or new Medical Physicist Report if required
- If multisite ethical review: Clean and tracked versions of amended MASTER documents – for example, aster PICF
- If single site ethical review: Supporting Department form/s (only if support required from a department that does not have a member on the research team)
Submitting your amendment application
- Please ensure that all required documents are completed and that the electronic files are clearly labelled
- Email your amendment submission to
This email address is being protected from spambots. You need JavaScript enabled to view it. including the Peter Mac Project Number and the term ‘Amendment Submission’ in the subject line of the email. Electronic signatures or scanned copies of signed pages are accepted