Key Topics:

• Rationale for a Data and Safety Monitoring Board (DSMB)                                                   
• Composition, roles and responsibilities of a DSMBs
• Understanding the role of DSMBs in clinical trials and how they function
• DSMB Charter
• Statistical concepts relevant to DSMB
• Interim Analysis (group-sequential methodolgy ,stochastic curtailment, early stopping
• Role of investigators and statisticians in a DSMB
• Regulatory and ethical issues
• Open and Closed Reports
• Operations and Logistics of a DSMB meeting

Teaching Methods

1.Interactive lectures

2.Group work, to prepare a DSMB Charter

3.Case studies and Simulated sessions

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

Pre-requisites for participation: Fundamental knowledge of RCT designs and basics of biostatistics (different types of outcome measures and analyses)
*Seats limited and on first come first served basis. 

Venue:
 St John’s Medical College and Research Institute, 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 (NEFT & QR Code) details: 
https://forms.cloud.microsoft/r/Muj6EdcVTZ

Academics/ Regulators/ Ethics comm. members/ Others:

Early bird (Before 31st Aug):Rs.10,000/-

From 1st Sep- 20th Oct : : Rs.12,500/-

Industry:

Early bird (Before 31st Aug):Rs.15,000/-

From 1st Sep- 20th Oct : Rs.17,500/-