Seminars & Workshops
A Team-based Approach to Data and Safety Monitoring Boards

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
Tufts Center for Medical Education, Room 221
145 Harrison Avenue
Boston, MA

Registration

Please register here to attend.

 

Seminars & Workshops
Collaborative Institutional Review Board (IRB) Agreements

After completing this lecture, you will be able to:

  • Identify when you should use commercial IRBs
  • Describe what a disease-specific central review is
  • Define what an IRB Authorization Agreement is and when to use it
  • Discuss how to use the Harvard Catalyst Reliance Agreement and IRBshare
  • Explain how to work with your IRB office to identify the best IRB for your multi-site clinical study.

Taught by: Andreas K. Klein, MD, Gordon S. Huggins, MD, Ashley D. Hicks, CIP, and Jonathan M. Davis, MD.

Seminars & Workshops
Data Safety and Monitoring Boards

After completing this lecture, you will be able to:

  • Describe how a DSMB works
  • Explain the kinds of studies DSMBs should be used for
  • Discuss the role of the investigator in establishing a DSMB
  • List the Tufts CTSI resources that are available to assist investigators in establishing a DSMB.

Taught by: Tamsin A. Knox, MD, MPH.

Seminars & Workshops
Master Contracts

After completing this lecture, you will be able to:

  • Describe what a master agreement is and when you would use one
  • Explain how you use a master agreement to expedite your clinical trial
  • List three types of master agreements
  • Discuss the differences and similarities between the following master agreements: Federal Demonstration Project (PDP), Duke Rapid Start, the ACTA Workgroup, etc.

Taught by: Paul Murphy, JD, MPA.

Seminars & Workshops
Navigating Contracts and Agreements

After completing this lecture, you will be able to:

  • Describe the importance of the contract process in the research lifecycle
  • Discuss the ins and outs of the contract process
  • Explain the best practices of the contract process as it relates to research.

Taught by: Frederick M. Frankhauser, JD, MBA, RPh.

Seminars & Workshops
Principal Investigator IRB Responsibilities

After completing this lecture, you will be able to:

  • Describe the responsibilities of a Principal Investigator
  • Explain the steps required for IRB review and approval
  • Discuss best practices for conducting a clinical research study.

Taught by: Andreas K. Klein, MD.

Seminars & Workshops
What You Need to Know About DSMBs (But Were Afraid to Ask)

After completing this lecture, you will be able to:

  • Discuss the history of Data Safety Monitoring Boards (DSMBs)
  • Describe the goals of a DSMB and how it works
  • Explain why a study may need a DSMB
  • List the steps to set up, arrange and organize a DSMB
  • Identify how to select and invite members to participate on a DSMB
  • Define the elements of a charter and explain why it is important
  • Discuss how to organize DSMB meetings.

Taught by Tamsin Knox, MD, MPH