NHMRC sought a review of legal and policy barriers in Australia to promote a competitive and accessible clinical trials sector. This review details current indemnity and insurance arrangements concerning clinical trials across the public and private sectors.
In 2014, NHMRC engaged Rallis Legal to review indemnity and insurance arrangements for clinical trials in the public and private sectors. This report outlines the indemnity and insurance arrangements (as at May 2014) and concludes that indemnity and insurance arrangements should not be a barrier to a national approach for ethical and research governance.
* Please note that the name of the Clinical Trial Exemption (CTX) scheme changed to the Clinical Trial Approval (CTA) scheme in 2020. This change was instigated to more accurately reflect the nature of the scheme under the Therapeutic Goods Act 1989. References in linked documents to CTX should now be interpreted as references to CTA.
