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 (Human Research Ethics Committee) Amendment Form OR explanatory cover memo/email. 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 any amended project documents – for example, Protocol, PICF (Participant Information and Consent Form), Investigator Brochure
- Amended 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
- IF MULTISITE ETHICAL REVIEW: Clean and tracked versions of amended MASTER documents – for example, 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
This email address is being protected from spambots. You need JavaScript enabled to view it. 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