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THE PHARMA REVIEW (JANUARY FEBRUARY 2014)

I Compensation for Injury or Death During Clinical Trial

R. K. Rishi

Introduction: Any report of serious adverse event of death occurring in clinical trial, after due analysis shall be forwarded by the sponsor to Chairman of the Ethics Committee and Chairman of the Expert Committee constituted by the Licensing Authority as defined under rule 21(b) under Appendix XII with a copy of the report to the Licensing Authority and the head of the Institution where the trial has been conducted within ten calendar days of occurrence of the serious adverse event of death. The report of the serious adverse event other than death, after due analysis, shall be forwarded by the sponsor to the Licensing Authority, Chairman of the Ethics Committee and the head of the Institution where the trial has been conducted within ten calendar days of occurrence of the serious adverse event (para 2(2)(iv) of Schedule Y). 

 

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