In case of serious adverse events of death, the reports are examined by an independent expert committee constituted by DCGI to determine if the cause of death is due to following reasons, (which are considered as clinical trial related death) :
- adverse effect of investigational product(s);
- violation of the approved protocol, scientific misconduct or negligence by the Sponsor or his representative or the investigator;
- failure of investigational product to provide intended therapeutic effect;
- use of placebo in a placebo-controlled trial;
- adverse effects due to concomitant medication excluding standard care, necessitated as part of approved protocol;
- for injury to a child in–utero because of the participation of parent in clinical trial;
- any clinical trial procedure involved in the study
The expert committee also recommends the quantum of compensation to be paid by the sponsor or his representative and gives these recommendations to CDSCO, who  consider the recommendations of the expert committee and finalize the cause of death and the quantum of compensation in such cases, within three months of receiving the report of SAE of death.
In cases of serious adverse event other than death, CDSCO determines the cause of injury, if the cause is found to be due to any of the reasons mentioned above (as in the case of death) , the injury is considered as clinical trial related injury. However, CDSCO has an option to constitute an independent expert committee, wherever considered necessary, to examine such serious adverse event. In case of clinical trial related injury, CDSCO also determines the quantum of compensation within three months of receiving of the SAE. In case of clinical trial related injury or death, the Sponsor or his representative concerned shall pay the compensation as per the order of CDSCO within thirty days of the receipt of such order.