Letter to the EditorInternational Journal of Clinical Trials
Publication: Current perspective of severe adverse events and compensation requirements in India
Int J Clin Trials. 2014;1(2):76-77.DOI10.5455/2349-3259.ijct20140809
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.
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Affiliations
- Department of Clinical Operations, SIARAM Clinical Research Centre, Bikaner, Rajasthan, India
- Department of Oncology, Acharya Tulsi Regional Cancer Treatment and Research Institute, Sardar Patel Medical College and AG of Hospitals, Bikaner, Rajasthan, India