This type of application relates to National Mutual Acceptance. It is required when the Austin Health CRRC 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, date and CAS booking number. 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/CRRC 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.
“Low risk research” is defined as research in which the only foreseeable risk is one of discomfort. “Negligible risk research” is defined as research in which the only foreseeable risk is no more than inconvenience.
Please note: If your study requests a waiver of consent (as per Chapter 2.3 of the National Statement) then the study cannot be LNRR. If this is the case, please see 'Single Site Submission' for submission requirements.
· HREA (Human Research Ethics Form - signed by All PIs & Head of Department) - - Please ensure to populate the HREC Reference Number
· 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
NOTE: No Victorian Specific Module (VSM) is required LNRR applications if LNR Vic Form is used.
· 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/)
· Site Budget - Grant Approval or funding agreement
· 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.)
b) complaints section contact details guidelines
· For the Person Responsible Oral Information and Consent template, please see SOP 006
· Austin Health Site Specific Patient Card/Diary/Questionnaire/Survey
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