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Description
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).
Audience
Biotechnology Companies, DSMB/DMC Members, Faculty, Institutional/Signatory Officials, IRB Members, Medical Device Manufacturers, Pharmaceutical Manufacturers, Principal Investigators, Research Administrators, Statisticians
Meet the Authors
Carson Reider, MS, PhD – Ohio State University
- Dr. Reider was a founding member of the National CTSA DSMB Working Group and has served as a contributing author for its DSMB Training Manual. He has also participated in the CTTI DSM Initiative and serves as a bioethics specialist reviewer for select U.S. Department of Defense CDMPR Review Panels.
Barbara N. Hammack, PhD, MS, MA – University of Colorado Denver
- Dr. Hammack received a PhD in Biochemistry from the University of Denver for work related to the thermodynamics of protein folding. She has a strong background in clinical research, providing safety oversight, advising about study design and conduct, and participating as a primary IRB reviewer. She served as a contributor and editor for the CTSA DSMB Training Manual.
Frederick W. Luthardt, Jr., DBe, MA – Johns Hopkins University
- Dr. Luthardt is the Director of the Office of Human Subjects Research, Compliance Monitoring Program at Johns Hopkins University (JHU), where he also serves as a Research Participant Advocate in the Clinical Research Unit, Institute for Clinical and Translational Research (ICTR), Johns Hopkins Bayview Medical Center. He is a DSMP/DSMB Consultant at JHU. Dr. Luthardt’s training is in bioethics, with 25 years of experience in clinical trials.
Laurel Yasko, MPPM, RN, CCRC – University of Pittsburgh
- Laurel Yasko is the Executive Director of Operations and Co-Core Director, Regulatory Knowledge and Support and Workforce Development for the University of Pittsburgh’s Clinical and Translational Science Institute. She has expertise in clinical research coordination, management, and regulatory aspects of clinical research.
