Insurance and Indemnity
The commercial sponsor of a clinical trial must provide executed indemnities in favour of the Public Health Organisation at which the research will be conducted. In addition it should provide executed indemnities for the lead HREC reviewing the trial. Evidence of appropriate insurance should also be supplied.
Medical Technology Association of Australia (MTAA) Forms of Indemnity for device trials (Standard) can be found here.
For information on documentation required to be submitted to the Ethics Committee click here.