The Tata Memorial Hospital Ethics Committee has
established the Data and Safety Monitoring Sub Committee for
monitoring the conduct of the institutional trials. The Committee
has 15 members and meets on the first Friday of every month.
The mandate of the Committee is to :
- Monitor the overall progress of institutional clinical
trials and for ensuring adherence to clinical trial and
- Ensure the safety of participants, validity of data, projected
accrual goals are maintained.
- Ensure that eligibility and evaluation criteria are followed,
that risks are not excessive.
- Adverse events are appropriately monitored and reported
to the appropriate agencies.
- Enhance the quality of the research by providing the investigator
with constructive criticism.
- Provide regular reports to the Hospital Ethics Committee
SOPs of Data and Safety
Monitoring Sub Committee (Html Format)
SOPs of Data and
Safety Monitoring Sub Committee ( Pdf Format)