Clinical Trial Insurance for New Clinical Trial Applications

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This communication aims to emphasise to various stakeholders conducting Clinical Trials the requirements for new clinical trial applications regarding liability insurance for clinical trials.

When applying to SAHPRA for approval of a new clinical trial, proof of active participant insurance cover for the trial must be included in the submission. The insurance quotation letters, letters of intent, or pro forma certificates are not acceptable. As indicated in the Clinical Trial Application Form (CTF1), applications submitted without an insurance certificate will be rejected at the screening phase and will not be accepted for review.