Amendments: governance review

Multisite ethical review projects must submit amendments to the reviewing Human Research Ethics Committee (reviewing HREC) for that project. Once an amendment ethical approval has been issued by the reviewing HREC, a Governance Amendment application can be submitted for the Peter Mac site.

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

The Principal Investigator (PI) or delegate is responsible for submitting the amendment for governance review. The Principal Investigator will be advised of the outcome of the review and any further queries or requirements.

Submission due dates

Submit at any time.

Preparing your governance amendment application

Required documents

  • Completed Amendment Form signed by the Principal Investigator
  • Amendment Ethical Approval
  • Ethically approved documents e.g. Protocol, PICF, Investigator Brochure, master PICF
  • Peter Mac site-specific Participant Information and Consent Form/s (PICF) and any other site-specific documents (based on the ethically approved master documents). Tracked (showing all deletions and additions/changes) and clean copies are required.
  • Supporting Department form/s, if required
  • 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.

IMPORTANT NOTE: If Peter Mac Ethics Committee was the reviewing HREC, all documents ethically approved by the Peter Mac Ethics Committee do not need to be submitted again.

Submitting your governance 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 ‘Governance Amendment’ in the subject line of the email. Electronic signatures or scanned copies of signed pages are accepted.