Clinical Trials

The University has protection which covers bodily injury of research subjects that results from the subjects participation in University clinical trials.

Clinical Trials are defined as:

A study or research involving humans:

  1. to test a drug, a surgical, therapeutic, preventative or diagnostic procedure or device where the nature of the study or study is such that it requires the investigator or an assistant to be a registered medical practitioner or other registered qualified health service provider; or
  2. requiring any invasive procedure to be undertaken by a registered medical practitioner or other registered quality health service provider.

For the purposes of this definition, invasive procedure means any procedure involving:

  1. penetration of the skin (other than taking of blood samples)
  2. biopsy or any taking of or extraction of tissue samples; or
  3. penetration of the bodily orifices (other than ears or mouth).

The definition of Clinical Trials does not include research or study

  1. involving evaluating outcomes of established healthcare management or treatment relating to condition or illness from which the participants are suffering; and/or
  2. only involves the participants completing questionnaires or interviews.

NB: Any knowledge of an event or which may give rise to a claim should be reported immediately to the Insurance team of the Risk and Assurance Unit.  Failure to do so may limit or negate the insurance protection available to the University.

Information and Contacts

Name Telephone Position
Shae McGrath (02) 4985 4366
Risk Officer
Risk and Assurance Services
Sara Knight (02) 4921 6489
Manager
Risk and Assurance Services

Note: The material furnished in this web site is for information purposes only and does not constitute an insurance contract upon which claims can be made. In the event of loss, damage or liability of any kind, the wording, terms, conditions and exclusions of the original policy shall have precedent over any other document.