Key Topics:

• Rationale for Data and Safety Monitoring Board (DSMB)                                                   
• Composition, roles and responsibilities of DSMBs
• DSMB Charter
• Statistical concepts relevant to DSMB
• Open and Closed Reports
• Logistics of DSMB meeting
• Interim Analysis (group-sequential methodology, stochastic curtailment, early stopping)
• Regulatory and Ethical issues

Teaching Methods

1.Interactive lectures

2.Group work, to prepare a DSMB Charter

3.Case studies

4.Simulated sessions

5.Journal Club

Outcome

1.Knowledge and skills on DSMB

2.Development of a DSMB Charter

Who can apply:

Clinical Researchers, DSMB members (current and future), Pharma Industry professionals, Ethics Committee Members, Regulators and Biostatisticians
*Seats limited and on first come first served basis. 

Venue:
CG Hall, (St Johns’s Medical College), Bengaluru
Accommodation:
Available on campus
Non-AC: Twin Sharing: Rs.1050/- per day; Single: Rs.788/- per day
AC: Twin Sharing: Rs.2100/- per day; Single: Rs.1576/- per day
Registration & Payment (DD and NEFT) details: 
https://forms.cloud.microsoft/r/Muj6EdcVTZ

Academics/ Regulators/ Ethics comm. members/ Others:

Early bird (Before 15th Aug):Rs.10,000/-

From 15th Aug-08th Oct : Rs.12,500/-

Industry:

Early bird (Before 15th Aug):Rs.15,000/-

From 15th Aug-08th Oct : Rs.17,500/-