Amendments

 

Amendments to HREC Approved Projects

All proposed changes to an HREC approved project must be submitted to the HREC for review prior to implementation of the amendment.

How do I submit an amendment for approval by the HREC?

Update the study document (e.g. protocol, advertisement, PIS/CF) by tracking changes on the HREC approved document, (remembering to change the version/date)

1. Complete the ‘Application form for an Amendment to an Approved Research Project’
2. Submit in hard copy the ‘Application form for an Amendment to an Approved Research Project’, and both clean and tracked versions of amended study documents
3. Email an electronic copy the scanned ‘Application form for an Amendment to an Approved Research Project’, and both clean and tracked versions of amended study documents to the Research Office email ( This e-mail address is being protected from spam bots, you need JavaScript enabled to view it )
4. Pay submission fee (if applicable)
5. Provide Fee Payment details with the submission (if applicable)

Amendments to Authorised Research Projects for Governance Officer review

The Principal Investigator at site is responsible for notifying the Research Governance Officer of all HREC approved amendments (this includes updates to Investigator’s Brochures or equivalent) to a research project.  The HREC approved amendments need to be submitted prior to implementation of the amendment. 

How do I submit HREC approved amendments to the Research Governance Officer?

Submit the HREC approved amendments to the Research Governance Officer in hard copy with the following:

1. Cover letter which includes the following:
   • Study Title
   • St Vincent’s Research Office File Number
   • A brief summary of why the amendment was required
   • List of all documents submitted (including versions)
   • Signed by site Principal Investigator
2. HREC approval letter which provides the details of the approved amended documents.
3. Updated Patient Information and Consent Forms – both clean and tracked versions on appropriate site letterhead (if applicable).
4. Amendment to the Clinical Trial Research Agreement on Australian Sponsor letterhead [minimum 2 copies – (Research Office copy and Sponsor copy)].
5. Submit documentation in hard copy, and;
6. Email an electronic copy the scanned cover letter, HREC approval letter and amended study documents to the Research Office email ( This e-mail address is being protected from spam bots, you need JavaScript enabled to view it )

Note: If St Vincent’s HREC has conducted the ethical review for the project please refer to the HREC amendment approval letter which will specify whether the amendment needs additional review by St Vincent’s Research Governance Officer.