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 or 02 6174 3949