Guideline for Liability Insurance for Clinical Trials

Guideline for 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 Products 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.

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Document Number: SAHPGL-CEM-CT-05
Version: 1
Date Updated: 27/03/2026
File Type: www
Category: Guideline
Unit: Clinical Evaluations Management, Clinical Trials