Liability Insurance for Clinical Trials

This document has been prepared to serve as a guideline to clarify the requirements of insurance for those who conduct interventional clinical trials involving human participants and intend on making a submission for approval of a clinical trial by South African Health Product s Regulatory Authority (SAHPRA). SAHPRA reserves the right to request any additional information and may make amendments in keeping with the knowledge which is current at the time. Guide lines and application forms are available from the Office of the Chief Executive Officer and SAHPRA website .