Data Monitoring Committees: A Guide for New Leaders and Members

This module provides a brief overview of data and safety monitoring (DSM) and notes the need for monitoring, the general process to determine that need, and the forms that monitoring may take. It explains the general DSM procedures as defined by data and safety monitoring plans (DSMPs). The module also introduces data monitoring committees (DMCs) and describes their interactions with other clinical trial stakeholders, such as sponsors, research sites, and Institutional Review Boards (IRBs).

Recommended Use: Required
ID (Language): 21172 (English)
Author(s): Carson Reider, PhD - Ohio State University

This module discusses the key elements of a DSMP, such as the safety factors to be assessed, the ways in which the investigation might impact participants, potential risks, individual- and study-stopping rules, and the person(s) who will have primary responsibility for data and safety monitoring. It further explains how monitoring guidelines are derived from the protocol risk assessment, with different monitoring requirements associated with minimal or low risk, moderate risk, or high risk studies. Lastly, the module addresses salient statistical concepts, including stopping rules and interim analyses, as well as some best practices for protecting confidential information.

Recommended Use: Required
ID (Language): 21173 (English)
Author(s): Barbara N. Hammack, PhD, MS, MA - University of Colorado Denver

This module identifies the role that charters play in directing the creation and operation of DMCs. It describes the different kinds of DMCs and defines the roles and responsibilities associated with DMC membership. The module also examines the sequence of meetings, topics discussed in open and closed meeting sessions, and the different types of documentation the committee reviews and produces.

Recommended Use: Required
ID (Language): 21174 (English)
Author(s): Barbara N. Hammack, PhD, MS, MA - University of Colorado Denver

This module details the DMC review process. It describes the different kinds of meetings, including initial, interim, final, and ad hoc. The module explains how DMCs monitor efficacy, safety, and study conduct, as well as their meeting structures and agendas. It concludes with an examination of meeting outcomes wherein DMCs recommend the continuation, modification, or termination of the research.

Recommended Use: Required
ID (Language): 21175 (English)
Author(s): Frederick W. Luthardt, Jr., DBe, MA - Johns Hopkins University

The module describes different approaches to meeting National Institutes of Health (NIH) data and safety monitoring regulations. It identifies U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) requirements regarding DMCs. The module also explains DMC considerations according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the Council for International Organizations of Medical Sciences (CIOMS).

Recommended Use: Required
ID (Language): 21176 (English)
Author(s): Laurel Yasko, MPPM, BSN, RN - University of Pittsburgh; Frederick W. Luthardt, Jr., DBe, MA - Johns Hopkins University