Insurance Requirements for Sponsored Clinical Trials

The following is necessary to meet the Territory’s requirements:

  • The insurance certificate must specifically name the Australian Corporate entity acting as commercial sponsor as a named insured under the relevant insurance policy
  • If the certificate is provided in the name of an overseas parent company, it must name the Australian entity as a subsidiary
  • The insurance certificate must include a valid coverage period for the policy
  • The insurer providing the cover must be approved by the Australian Prudential Regulation Authority and must have a minimum financial strength rating of A- or above
  • The insurance certificate must provide coverage of AUD$20 million for each and every occurrence and AUD$20 million in the annual aggregate against a class of insurance appropriate for the risk associated with the research.

The requirements listed above do not apply to low risk ethics proposals. For queries please contact research.governance@act.gov.au or 02 6174 3949