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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 procedural requirements.
  • 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

Related links
SOPs of Data and Safety Monitoring Sub Committee  (Html Format)

SOPs of Data and Safety Monitoring Sub Committee   ( Pdf Format)

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