The justification for the substantial amendments 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. Please note that your amendment will be triaged to the appropriate committee for review.
Preparing your substantial amendment application
Required documents
- Completed and signed Human Research Ethics Committee (HREC) Amendment Form. The form can be created and submitted in Ethics Review Manager (ERM) as a sub-form of the project Human Research Ethics Application (HREA). Alternatively, please complete the Amendment Form found in ‘Useful resources, training, and forms.’ The amendment form must clearly explain the nature of the amendment and the changes being made to each document.
- Clean and tracked versions of amended project documents – for example: Protocol, PICF (Participant Information and Consent Form), Investigator Brochure
- Any newly added project documents - clearly indicate which documents are new
- 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, Master PICF
- HREC Indemnity (if impacted)
- If single site ethical review:
- Supporting Department form/s (only if services provided by departments are impacted by the amendment)
- CTRA (if impacted)
- Standard Indemnity (if impacted)
- If Peter Mac is the Sponsor, amendments must first be approved by the Clinical Research Sponsorship Committee and approval included in your submission. Please contact
This email address is being protected from spambots. You need JavaScript enabled to view it. if Clinical Research Sponsorship Committee approval required.
Submitting your substantial 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