Insurance and Indemnity

For clinical trials - an indemnity must be provided by the sponsor for all sponsored clinical trials and the prescribed format must be followed

• Drug Trials - Two (2) copies each of the Standard Medicines Australia Form of Indemnity for Clinical Trials and HREC Review Only Medicines Australia Form of Indemnity For Clinical Trials as applicable. 
   
• Device Trials – Two (2) copies each of the Standard Medical Technology Association of Australia Form of Indemnity for Clinical Investigation and HREC Review Only Medical Technology Association of Australia Form of Indemnity for Clinical Investigation as applicable.

Please refer to the Victorian Managed Insurance Authority (VMIA) guidelines for further information regarding insurance for clinical trials 

• VMIA Guidelines for Clinical Trials - For Victorian Public Hospitals (2009)

To ensure you are using the latest version of the application form, please download the document directly from the Office for Research web site each time you prepare a new application.

The aim of this research project application package are to:

• facilitate the efficient and thorough review of research involving humans;
• ensure that the research is conducted in accordance with the National Statement on Ethical Conduct in Human Research (2007)

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