Clinical Trial Insurance in Current Perspective of Compensation Requirements in India

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New compensation guideline for clinical trial participants in case of death and injury has been introduced after recent amendment in schedule Y (Rule 122DAB – Compensation in case of injury or death during clinical trial).

  • Formula to Determine the quantum of compensation in the cases of Clinical Trial related serious Adverse Events(SAEs) of Deaths Occurring During Clinical Trials
  • Guidelines on Formula to determine the quantum of compensation in case of Clinical Trial related Injury

These guidelines give clarity on the approximate amount of compensation calculation procedure to Ethics Committees and Sponsor. It is very clearly stated in regulation that the responsibility of medical management and compensation in case of clinical trial related injury lies with the sponsor. It is very important to have proper clinical trial insurance policy to safeguard the sponsor in case such an event. This webinar is designed to answer the queries of stakeholders on clinical trial insurance and framed to cover following questions. Also the registered participants can send their questions in advance to address during the webinar.