Responsibilities of the Investigator: (i) The investigator shall be responsible for the conduct of the investigation according to clinical investigation plan, GCP guidelines and also for compliance as per the undertaking by the investigator as given in Table 9 of this Schedule. Standard operating procedures are required to be documented by the investigators for the tasks performed by them. During and following a subject's participation in an investigation, the investigator should ensure that adequate medical care is provided to the participant for any adverse events. Investigator shall report all serious adverse events to the Central Licensing Authority, sponsor or his representative, whosoever had obtained permission from the Central Licensing Authority for conduct of the clinical investigation, and the Ethics Committee that accorded approval to the clinical Investigation plan, within forty-eight hours of their occurrence. In case the Investigator fails to report any serious adverse event within the stipulated period, he shall have to furnish the reason for the delay to the Central Licensing Authority along with the report of the serious adverse event. The detailed report of the serious adverse event, after due analysis, shall be forwarded by the investigator to Chairman of the Ethics Committee, Central Licensing Authority and the head of the Institution where investigation has been conducted within fourteen calendar days of occurrence of the serious adverse event.