This three-day intensive workshop is designed to provide participants with a comprehensive understanding of the principles, functions and practical operations of DSMBs in clinical research. The workshop will cover the establishment and composition of DSMBs, their roles and responsibilities, statistical considerations, interim analyses, regulatory and ethical aspects, and the practical conduct of DSMB meetings.

Key Topics

• Rationale for establishing a Data and Safety Monitoring Board (DSMB)
• Composition, roles and responsibilities of a DSMB
• Understanding the role of DSMBs in clinical trials and how they function
• DSMB Charter
• Statistical concepts relevant to DSMBs
• Interim Analysis, including:
  • Group-sequential methodology
  • 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

Learning Outcomes

By the end of the three-day workshop, participants will develop:

1. Knowledge and practical skills related to DSMB functioning
2. An understanding of the statistical, regulatory and ethical considerations involved in DSMB activities
3. Practical experience in developing a DSMB Charter
4. Familiarity with the conduct and operations of DSMB meetings

Who Can Apply?

The workshop is intended for:

• Clinical Researchers
• Current and prospective DSMB Members
• Pharmaceutical Industry Professionals
• Ethics Committee Members
• Regulators
• Biostatisticians

Pre-requisites for Participation

Participants should have fundamental knowledge of Randomised Controlled Trial (RCT) designs and basic biostatistics, including different types of outcome measures and analyses.

Seats are limited and will be allotted on a first-come, first-served basis.

Venue

St John’s Medical College and Research Institute, Bengaluru

Accommodation

Accommodation is available on campus.

Non-AC

• Twin Sharing: ₹1,050 per day
• Single Occupancy: ₹788 per day

AC

• Twin Sharing: ₹2,100 per day
• Single Occupancy: ₹1,576 per day

Registration & Payment

Registration and payment can be made through NEFT or QR Code.

Registration Form:
https://forms.cloud.microsoft/r/Muj6EdcVTZ

Registration Fees

Academics / Regulators / Ethics Committee Members / Others

• Early Bird – Before 31 August: ₹10,000/-
• 1 September – 20 October: ₹12,500/-

Industry

• Early Bird – Before 31 August: ₹15,000/-
• 1 September – 20 October: ₹17,500/-