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.
1. Log in to the Ethics Research Management 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 RGO - ETHICS02@austin.org.au
For immediate confirmation that your email has reached us, set up an automated 'Delivery Receipt Notification' before you send your email.
· Fully signed (All Investigators & Head of Department) SSA (Site Specific Assessment Form; final version with submission code - no DRAFT watermark)
· GCP Certificate (http://www.austin.org.au/research/training-for-researchers/
· Signed Medicine Australia Standard Indemnities (If applicable)
· Insurance (If applicable)
· Site Budget
· Austin Health Victorian Specific Medical Physicist Module and Medical Physicist Report (If project involves radiation)
· Austin Health (AH) Site Specific PICF must include:
a) the PICF Austin Health (logo and barcode) Template and place for a patient label sticker (HIS will only accept a PICF on the standard AH template. No deviations to this template will be accepted.)
· For the Person Responsible Oral Information and Consent template, please see SOP 006
· Austin Health Site Specific Patient Card, etc. (If applicable)
· CTN/CTX for each site
· Complete a material transfer agreement if applicable. This agreement should be used when external parties want to be provided with materials such as tissue samples obtained by Austin Health and Austin Health's only role is to provide this material and is not involved as a collaborator in the research project.
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· 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