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. The form is created and submitted in ERM as a sub form of the project HREA. 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 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.
