A Guide to Data and Safety Monitoring Boards (DSMB)

Reference: Data Monitoring Committees in Clinical Trials; A Practical Perspective By: Susan S. Ellenberg, Thomas R. Fleming and David L. DeMets

Key Points

Responsibilities of the Data Monitoring Committee

Composition of a Data Monitoring Committee

Independence of the Data Monitoring Committee: Avoiding Conflicts of Interest

Confidentiality Issues Relating to the Data Monitoring Committee

Data Monitoring Committee Meetings

Data Monitoring Committee Interactions with other Trail Components or Related Groups

Statistical, Philosophical and Ethical Issues in Data Monitoring

Determining When a Data Monitoring Committee is Needed

Regulatory Considerations for the Operation of Data Monitoring Committees

Helpful Websites for Developing a Data and Safety Monitoring Plan:

UTMB Procedure for Developing a Data Safety Monitoring Plan
Adverse Event Reporting on Patient Safety at UTMB
Adverse Event Reporting of Events with Human Subjects at UTMB
UTMB Data & Safety Monitoring Planning Computer-Based Course
HHS OHRP: Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
NIH Guidelines for Adverse Event Reporting
NIH Guidelines for Data and Safety Monitoring
Further NIH Guidance on Data and Safety Monitoring for Phase I and Phase II Trials
National Center for Complementary and Alternative Medicine
National Cancer Institute
National Cancer Institute Guidance for Conducting Clinical Trials
National Heart, Lung and Blood Institute
National Institute on Aging
National Institute on Aging – Sample DSMP
National Institute of Allergy and Infectious Diseases
National Institute for Arthritis and Musculoskeletal and Skin Diseases
National Institute of Child Health and Human Development
National Institute on Drug Abuse
National Institute of Dental and Craniofacial Research
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Mental Health
National Institute of Neurological Disorders and Stroke