Current perspective of severe adverse events and compensation requirements in India

Authors

  • Shekhar Goyal Department of Clinical Operations, SIARAM Clinical Research Centre, Bikaner, Rajasthan, India
  • Akhil Kapoor Department of Oncology, Acharya Tulsi Regional Cancer Treatment and Research Institute, Sardar Patel Medical College and AG of Hospitals, Bikaner, Rajasthan, India
  • Indra Bhadu Department of Clinical Operations, SIARAM Clinical Research Centre, Bikaner, Rajasthan, India

DOI:

https://doi.org/10.5455/2349-3259.ijct20140809

Keywords:

Adverse events, Clinical trial

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.

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.

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Published

2014-08-01

Issue

Section

Letter to the Editor