Reporting of Serious Adverse Reaction (SAE)

The Investigator has to report all serious and unexpected adverse events to the CDSCO, the Sponsor or his representative whosoever had obtained permission from the CDSCO for conduct of the clinical trial and the Ethics Committee, within 24 hours of their occurrence as per the desired format. The IEC determines the causality of the SAE as to whether it is related to the investigational drug or not. The IEC gives its opinion to the expert committee constituted by the Ministry of Health. The expert committee also determines if the SAE is causally related to the drug and recommends suitable compensation based on a formula. The DCGI then directs the sponsor to pay compensation to the participant or to his/her relative.