Administrative amendments: ethical review

Administrative amendments can be reviewed and approved by the Ethics Committee Secretariat and can be submitted at any time. Examples include: addition or change of study personnel; update to contact or sponsor details; correction of minor errors; increase in accrual number.

Submission due dates

Submit at any time.

Preparing your administrative amendment application

Required documents

  • Completed and signed HREC Amendment Form OR explanatory cover memo/email.
  • Clean and tracked versions of any amended project documents e.g. Protocol, PICF, Investigator Brochure
  • Amended CTN if required. Please see the TGA CTN scheme site for advice on how notify the TGA of changes to the CTN.
  • IF MULTISITE ETHICAL REVIEW: Clean and tracked versions of amended MASTER documents e.g. Master PICF
  • IF SINGLE SITE ETHICAL REVIEW: For increase in the accrual number an amended budget, contract and/or Supporting Department form/s may be required

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