Monitoring
ADVERSE EVENT
The study is to be monitored by Cipto Mangunkusumo Hospital Research Unit. Research records for all study subjects including CRFs, laboratory, and other investigation data/results are to be maintained by the investigator in secure storage for five years. These records are to be maintained in compliance with all designated IRBs requirements. It is the investigator’s responsibility to retain copies of these study records until notified in that they can be destroyed. Any severe adverse event or unintended effects of trial intervention will be reported and assessed by the ethics committee.