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COVID 19 FAQ 428: In a clinical trial death how to calculate the compensation

投稿日:

Compensation =   BX F x R                                  99.37B = Base amount (i.e. 8 lacs)
F = Factor depending on the age of the subject as per Annexure 1 (based on Workmen Compensation Act)
R = Risk Factor depending on the seriousness and severity of the disease,  presence of co-morbidity and duration of disease of the subject at the time of  enrolment in the clinical trial between a scale of 0.5 to 4 as under:
1 .0.50 terminally ill patient (expected survival not more than (NMT) 6 months)2. 1.0 Patient with high risk (expected survival between 6 to 24 months)3. 2.0 Patient with moderate risk4. 3.0 Patient with mild risk5 4.0 Healthy Volunteers or subject of no risk
However, in case of patients whose expected mortality is 90 % or more within 30 days, a fixed amount of Rs. 2 lacs should be given.
Thus, it will be seen that the compensation amount will vary from a minimum of Rs.4 lacs to a maximum of Rs.73.60 lacs depending on the age of the deceased and the risk factor.
The committee will examine cases of SAEs of deaths and decide the final quantum of compensation after due diligence and application of mind on the risk factor and recommend the same to DCG (I) on case to case basis. The committee also considered the above formula as provisionally final.

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