DOI: http://dx.doi.org/10.5455/2349-3259.ijct20140809

Current perspective of severe adverse events and compensation requirements in India

Shekhar Goyal, Akhil Kapoor, Indra Bhadu

Abstract


As per Drug Controller General of India (DCGI), there are clear cut compensation guidelines for clinical trial participants in case of death and injury after amendment in schedule Y (Rule 122DAB - Compensation in case of injury or death during clinical trial). The purpose of these guidelines is to provide Severe Adverse Event (SAE) compensation calculation as well as determination of the ratio of amount in clinical trial injury.

Keywords


Adverse events, Clinical trial

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References


CDSCO. Compensation formula (Clinical trial), 2013. Available at: http://cdsco.nic.in/writereaddata/formula2013SAE.pdf. Accessed 28 June 2014.

Manoj Karwa. Compensation formula by DCGI for cases of clinical trial related SAEs of Death, 2013. Available at: http://www.aurigaresearch.com/2013/09/compensation-formula-by-dcgi-for-cases-of-clinical-trial-related-saes-of-death/. Accessed 27 June 2014.