Substantial amendments: ethical review

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 will impact on the type or frequency of service provided by any supporting departments at Peter Mac then a Supporting Department form/s will also be required.

Multisite Ethical Review Projects:

  • 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 Amendment Form
  • Clean and tracked versions of amended project documents e.g. Protocol, PICF, Investigator Brochure
  • Any newly added project documents
  • Amended or New CTN if required. Please see the TGA 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 e.g. Master 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 [email protected] 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.