Webinar: Data and Safety Monitoring

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Overview

Data and safety monitoring boards (DSMBs) and IRBs are two distinct but related committees concerned with the ethical and safe conduct of research. How can DSMBs, IRBs, investigators, and sponsors work together to ensure scientific integrity and subject safety? Expanding on foundational knowledge in the module Data and Safety Monitoring in Human Subjects Research, part of CITI Program's Biomedical Basic course, this advanced-level webinar will:

  • Summarize relevant guidance documents from government and non-government organizations, including FDA, NIH, EMA, and WHO
  • Help IRBs understand when a DSMB is needed and clarify each body's purview when it comes to subject safety
  • Discuss reporting mechanisms for adverse and unanticipated events in data and safety monitoring plans, with specific consideration given to multicenter trials
  • Present interactive case scenarios to highlight complex "gray areas" in data and safety monitoring

The webinar will conclude with an interactive question and answer session where attendees can pose questions to the speakers.

This webinar will not review basic regulatory knowledge. Attendees should complete CITI Program’s module or have equivalent foundational knowledge before registering for this webinar.

Learning Objectives

After attending this webinar, attendees will be able to:

  • Understand the responsibilities of the IRB, the DSMB, the investigator, and the sponsor in ensuring scientific integrity and subject safety in clinical trials
  • Understand the regulations and policies relating to data and safety monitoring developed by regulatory authorities and trial funders
  • Apply guidance and strategies to handle complex situations that may arise during data and safety monitoring

Intended Audience

This webinar will benefit IRB staff and members; investigators and research staff; sponsors; and DSMB members who have completed CITI Program's module Data and Safety Monitoring in Human Subjects Research as part of the Biomedical Basic course, or have other background knowledge or experience, and are interested in expanding on that knowledge.

Continuing Education

CIP Credit labelWebinar participants holding the Certified IRB Professional (CIP®) credential may apply 1.5 continuing education credits towards CIP recertification. Learn More »

Speakers

Stephen M DavisStephen Davis, MPA, MSW is an adjunct professor of emergency medicine in the West Virginia University School of Medicine, where he teaches clinical research methods and principles of evidence based medicine to undergraduate and graduate students. He also holds an adjunct associate professor appointment in the Department of Health, Policy, Management, and Leadership in the West Virginia University School of Public Health. Mr. Davis has over 15 years of experience conducting emergency department research with specialization in stroke awareness and analyses of large-scale datasets to denote national trends in hospitalizations and emergency department utilization and care. He is a past Chair and current member of the West Virginia University Institutional Review Board. He regularly lectures on the ethical conduct of research and recently completed a book chapter on ethical issues in pharmaceutical research. Mr. Davis is currently completing his doctorate in Public Health Science with a particular interest in syringe exchange programs for the prevention of Hepatitis C virus.

Susan EllenbergSusan Ellenberg, PhD joined the biostatistics faculty at the University of Pennsylvania as professor of biostatistics in the fall of 2004. Dr. Ellenberg directs the Biostatistics Core for the Penn Center for AIDS Research, and is also collaborating on projects in endocrinology, anesthesiology, breast cancer, pulmonary hypertension and HIV. Prior to arriving at Penn, Dr. Ellenberg held leadership positions at the National Institutes of Health and the Food and Drug Administration. Her areas of research have included surrogate endpoints for treatment effects in clinical trials, operational issues for data monitoring committees, clinical trial designs, adverse event monitoring, vaccine safety and special issues in cancer and AIDS trials. Dr. Ellenberg is a Fellow of the American Statistical Association, the Society for Clinical Trials and the American Association for the Advancement of Science, and is an elected member of the International Statistical Institute. She has served as President of the Eastern North American Region (ENAR) of the International Biometric Society, and of the Society for Clinical Trials. She also served on the Board of Trustees of the National Institute of Statistical Sciences, and chaired that Board from 2011-14. She is an Associate Editor of Clinical Trials and the Journal of the National Cancer Institute, and serves on the Advisory Board of Trials. Her book, Data Monitoring Committees in Clinical Trials: A Practical Perspective, co-authored with Drs. Thomas Fleming and David DeMets, was named Wiley Europe Statistics Book of the Year for 2002. Dr. Ellenberg holds a secondary appointment in the Department of Medical Ethics and Health Policy.

Additional Resources

A collection of relevant background reading, further reading, links, templates, checklists, and/or charts accompany each PRIM&R webinar. Groups that register for webinars receive a discussion guide containing thought-provoking questions and facilitation tips that may help in using the webinar as an educational tool for IRBs.

Background:

Attendees should complete CITI Program's module Data and Safety Monitoring in Human Subjects Research, located within the Biomedical Basic course, or have other background knowledge or experience with data and safety monitoring before attending this webinar.

Collaborator

CITI Logo

PRIM&R is pleased to collaborate with CITI Program to present this webinar.

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