Clinical Trials

Clinical trials are research studies that test medical, surgical, or behavioral intervention in people. Clinical trials are the primary way that researchers determine if a new form of treatment or prevention, such as a new drug, diet, or medical device is safe and effective in humans.

Clinical Trials generally run over four phases during human testing:

Clinical Trial Insurance provides protection for the participants/research subjects of a trial for any injury directly from a clinical trial. We define injury as any serious bodily injury of an enduring and disabling character (including exacerbation of an existing condition), sickness, disease, disability, loss of amenities, disfigurement and death.

Statutory requirements to have adequate insurance coverage for clinical trials:

In accordance with the Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa as issued by the Department of Health: Pretoria, South Africa.

"The sponsor/applicant as described in the Good Clinical Practice (GCP) Guidelines, all sponsors/applicants and investigators of clinical trials must have adequate comprehensive insurance to cover for any liability claim during the conduct of a clinical trial."