Year Published: 2014

Time to Complete: 75 min

Instructor: Tamsin Knox, MD, MPH; Farzad Noubary, PhD; Julie SantaCroce Burt

Learning Level: Fundamental

Primary Audience: Research Team

Prerequisite: None

Skills Domain: Ethical and Participant Safety Considerations; Clinical Study Operations (Good Clinical Practice)

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.

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

Content Outline

1. Introduction & Overview of DSMBs

  • What is DSMB and Why do we Need it?
  • What is the Function of a DSMB?
  • Which Studies Need a DSMB?
  • Which Studies Need a DSMB Self Check?
  • Other Monitoring Options
  • How do DSMBs Work Meeting Members
  • How does a DSMB differ from the IRB
  • The DSMB Charter Responsibilities
  • A DSMB Meeting & Meeting Report

2. Importance of Data for Effective DSMB Review

  • Importance of Data for Effective DSMB Review
  • Data we Need for DSMB Review
  • Electronic Database Expected Data Problems
  • Role of Coordinator in DSMB Managing & Reporting

3. Dealing with Different Types of Safety Events

  • DSMB Initial Review Safety Events
  • DSMB Safety Review
  • Biostatistical lssues - Study Termination & Interim Analyses
  • Four Statistical Methods for Decision Making
  • Group Sequential Methods Pre-specified Plan
  • Recap Plan A Study with DSMB

Resources

  • Lecture Slide Deck
  • DSMB Problem Sets

Course Evaluation

  • Post-Course Evaluation
  • Course Completion Verification
 This Course is Free