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Research

External HREC Accepting Submissions - New Applications

This type of application relates to National Mutual Acceptance. It is required when Austin Health is a participating site of a multicentre study, where ethical approval has been granted by an external lead HREC. The submission of a site specific governance package is required.

Please see the list below of required documents and refer to the instructions for submitting your Governance Package.

A Project Authorisation letter can be issued only once all the site specific documents have been submitted and reviewed. A research project may not commence at Austin Health until a Project Authorisation letter has been received.

Forms: External HREC accepting submissions - new applications

Governance package

If applicable:

 

  • LEAD HREC APPROVAL Letter
  • LEAD HREC APPROVED HREA (Human Research Ethics Application Form)
  • LEAD HREC APPROVED VSM (Victorian Specific Module}
  • LEAD HREC APPROVED Protocol
  • LEAD HREC APPROVED Master PICF
  • LEAD HREC APPROVED Master Patient card/Diary/Questionnaire/Survey etc
  • LEAD HREC APPROVED Investigator Brochure
  • LEAD HREC REVIEW ONLY Indemnity

Submitting your Governance Package

1. Log in to the Ethics Review Manager website

2. Complete the SSA as appropriate.

3. Upload all supporting documentation (Note: scanning may be required)

4. Email an electronic copy of your submission to ETHICS02@austin.org.au

 

Signatures

Signatures should be submitted with the project submission.
Digital signatures can be inserted into documents such as the HREA and SSA and saved as a PDF.

Wet ink signed pages should be individually scanned and saved as a PDF.


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