What is a Data Safety and Monitoring Board (DSMB), and how can it improve your study?

IRBs and funding agencies often require DSMBs for intervention studies. Find out what DSMBs do and how best to collaborate with them at a two-hour Tufts CTSI seminar, A Team-based Approach to Data and Safety Monitoring Boards (DSMBs). Led by clinical study experts, this interactive training will consist of didactic lectures, discussions, and group activities for investigators and their clinical study teams, including research fellows, coordinators, research nurses, data managers, biostatisticians, regulatory personnel, and IRB members.

Instructors/Facilitators

  • Tamsin Knox, MD, MPH, Associate Professor, Tufts University School of Medicine; Associate Director, Tufts CTSI, Regulatory Affairs and Clinical and Translational Research Center (CTRC)
  • Farzad Noubary, PhD, Assistant Professor, Tufts University School of Medicine, Biostatistician, Tufts CTSI, BERD Center
  • Julie SantaCroce Burt, Clinical Research Coordinator, Tufts Medical Center

Training Outline

  • Introduction & Overview of DSMBs
  • Primacy of Data for Effective DSMB Review: Planning, Managing, and Reporting
  • Dealing with Different Types of Safety Events
  • Working with Biostatisticians
  • Break
  • Group Activity/Table Exercises

Learning Objectives

By the end of this seminar, you will be able to:

  • Describe roles and responsibilities in working with a DSMB
  • Locate DSMBs’ extended scientific expertise and support in the context of a disease, population, or intervention
  • Recognize the importance of engaging a DSMB in an early stage of your study design
  • Recognize DSMBs’ comprehensive approaches to safety monitoring as valuable steps for patient safety

Details

Tuesday, March 27, 9:00-11:00AM
Arthur M. Sackler Center for Medical Education, Room 221
145 Harrison Avenue
Boston, MA

Registration

Please register here to attend.