Data Monitoring Committees: A Guide for New Leaders and Members

A role-based course that provides practical know-how to effectively lead or participate on data monitoring committees.

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About this Course

Data monitoring committees play a pivotal role in research.  It is important to train new leaders and members on their functions and responsibilities for serving on a DMC. This course, tailored to the roles of individuals on DMCs, includes instructions on how to create DMC charters, implement data and safety monitoring plans (DSMPs), conduct data reviews, and work effectively with principal investigators, study sponsors, and Institutional Review Boards (IRBs).

Course Preview:

Language Availability: English

Suggested Audiences: Biotechnology Companies, DSMB/DMC Members, Faculty, Institutional/Signatory Officials, IRB Members, Medical Device Manufacturers, Pharmaceutical Manufacturers, Principal Investigators, Research Administrators, Statisticians

Organizational Subscription Price: $675 per year/per site for government and non-profit organizations; $750 per year/per site for for-profit organizations
Independent Learner Price: $99 per person

Demo Instructions


Course Content

Overview of Data and Safety Monitoring

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

Understanding and Implementing DSMPs

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

Data Monitoring Committees

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

DMC Review Process

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

Institutional, National, and International Guidelines

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


FAQs

Who should take the Data Monitoring Committees: A Guide for New Leaders and Members?

Learners who wish to gain a foundational knowledge of data and safety monitoring should take this course to prepare for service on a DMC. Whether they be new leaders or simply new members of a DMC, our Data Monitoring Committees: A Guide for New Leaders and Members provides learners with core instruction on carrying out their roles and responsibilities.

Suggested audiences include biotechnology companies, DMC/DSMB members, faculty, institutional officers, medical device manufacturers, pharmaceutical companies, principal investigators, research administrators, institutional officers, statisticians, and Institutional Review Board (IRB) members.

How does the Data Monitoring Committees: A Guide for New Leaders and Members course complement other CITI Program courses?

Data Monitoring Committees serves as a helpful complement to CITI Program’s Good Clinical Practice (GCP) and Human Subjects Research (HSR) courses. It constitutes the next step in training for those who expect to participate in DMCs. Combined, they provide a comprehensive look at how safety is assured for drugs, biologics, and medical devices.

Why should someone take the Data Monitoring Committees: A Guide for New Leaders and Members course?

This role-based course focuses on training leaders and members of data monitoring committees (DMCs) on their functions and responsibilities for serving on a DMC. The course includes instructions on creating DMC charters, implementing data and safety monitoring plans (DSMPs), conducting data reviews, and working effectively with principal investigators, study sponsors, and Institutional Review Boards (IRBs).

How long will the course take a learner to complete?

This course consists of five modules. Each module contains detailed content, a quiz, images, supplemental materials, and case studies.

Modules vary in length, and learners may require different amounts of time to complete them based on their familiarity and knowledge of the topic. As a rule of thumb, modules can take about 30 to 45 minutes to complete, which means the course could take around 2.5 to 3.5 hours to complete.

Is this course eligible for continuing medical education credits?

This course does not currently have CE/CME credits available.

What are the required and supplemental modules for learner groups?

This course is designed to be completed sequentially through all five modules (we recommend they are set as “required”).

  • Overview of Data and Safety Monitoring
  • Understanding and Implementing DSMPs
  • Data Monitoring Committees
  • DMC Review Process
  • Institutional, National, and International Guidelines

What are the advantages of CITI Program's Data Monitoring Committees: A Guide for New Leaders and Members course?

This course provides peer-reviewed training written by data and safety monitoring experts. It is more comprehensive than other available online courses and offers practical knowledge on fulfilling the roles and responsibilities of a DMC leader or member.

CITI Program's advantages, including our experience, customization options, cost-effectiveness, and focus on organizational and learner needs, make it an excellent choice for clinical research training.


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