Note that fees may be applicable for amendments, and a method of payment (MOP) form is required for all amendments that incur fees.
Proposed changes to a Human Research Ethics Committee (HREC) approved project must be submitted to the Human Research Ethics Committee (HREC) and Research Governance Officer (RGO) for approval.
Amendments should include:
- A description of modifications and rationale including any summary of changes provided by the sponsor (if applicable)
- Implications for the ongoing conduct of the project
Please submit amended documents, tracked and clean, with a cover page summarising the changes for large documents. Documents should contain revised version numbers and include version dates and page numbers.
Instructions on how to submit an ethics amendment can be found
here and responding to an information request can be found
here .
Type of amendment:
Change to co-ordinating principal investigator (CPI) and/or the principal investigator (PI)
Documents required:
- Current CV (signed and dated) every two years
- Form on REGIS
Extension HREC approval (for projects lapsed by no more than 3 months)
Documents required:
Site addition
Documents required:
General amendments affecting the conduct, design or methodology, including changes to the HREA, protocol, PICF and/ or any other supporting documentation
Documents required:
- Cover letter
- Brief description of modifications and rationale, including any summary of changes provided by the sponsor.
- Method of payment form
- Documents to be amended
General amendment
Documents required:
- Cover letter
- Documents that need to be amended such as protocol, participant information sheet and consent form
Contract changes
Documents required:
Site investigators/ admin changes
Documents required:
