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Webinar: (2017-07) Data and Safety Monitoring: Advanced Issues and Case Studies

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.

(Presented on July 12, 2017)

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

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


CITI - Collaborative Institutional Training Initiative
PRIM&R is pleased to collaborate with CITI Program to present this webinar.

Access Interval
Access to purchased content will be available for 90 days after the date of purchase. After 90 days, access to the content will be removed, but users will retain access to any certificates of attendance earned. Content purchased prior to January 1, 2021 will remain available indefinitely. After access has expired, users can purchase an additional 90 days of access.

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