In this Section:
This type of application relates to National Mutual Acceptance. It is required when the Austin Health HREC is reviewing a project on behalf of multiple sites.
You must email the Office for Research as soon as possible to book a submission slot at your preferred meeting as numbers are limited. Your booking email should contain the following information: Protocol number and title, PI/CPI, preferred meeting, Drug or non-drug study, date. The Office for Research will confirm your submission booking via email.
Every research project at the Austin must undergo both an Ethics Review and a Site Specific Review (Governance). For Multi-Site Applications we recommend NOT submitting your Governance package until Ethics Approval has been granted.
Please see the list below of required documents and refer to the instructions for submitting your Ethics Package and Governance Package.
Where Austin Health is the reviewing HREC for multiple sites, approval will be notified by one Ethics Approval Letter for all sites. 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.
For immediate confirmation that your email has reached us, set up an automated 'Delivery Receipt Notification' before you send your email.
· HREA (Human Research Ethics Application Form; signed by All PIs & Head of Department) - - Please ensure to populate the HREC Reference Number
· Waiver of Consent Request Form - ONLY If a Waiver of Consent is being requested.
· Master PICF Complaints Section contact detail guidelines
· Master Patient card/Diary/ Questionnaire/Survey/Flyer
· For information regarding Likert scales, see: http://www.cdc.gov/dhdsp/pubs/docs/cb_february_14_2012.pdf
· Investigator Brochure
· HREC review only Indemnity (If commercially sponsored)
· 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)
· 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 AH logo and barcode 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)
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