The independent expert committees constituted by DCG(I) has finally prepared a formula for compensation in case of SAEs of Death which majorly take age and risk factor into consideration. After computing the 3 factors viz. a) Age b) Risk and c) base amount, following formula emerged for deciding the quantum of compensation in case of SAE (Death) related to clinical trial:
Compensation = BX F x R
99.37
Where,
B = 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 risk
4. 3.0 Patient with mild risk
5 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.
Please visit below link for more detail
http://www.cdsco.nic.in/formula2013SAE.pdf
Further as per DCG (I) another recent circular dated 30.08.13 [No. DCGI/MISC/2013(107], Sponsor shall also furnish the copy of financial contract entered with the investigator/institutes along with clinical trial application.
Please visit below link for more detail
http://www.cdsco.nic.in/Furnising%20of%20information%20in%20respect%20of%20financial%20support%202013.pdf
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