MCW Data Safety Monitoring for Research

Data Safety Monitoring (DSM)

An IRB is responsible for determining if a study needs formal ongoing monitoring of data to ensure that research subjects will be protected. This responsibility stems from DHHS and FDA regulations stating a criterion for study approval be that "when appropriate, the research plan makes adequate provisions for monitoring the data collected to ensure the safety of subjects" 45 CFR 46.111[a][6]

Data Safety Monitoring Committee or Boards (DSMC/B)

A DSM Committee or Board is an independent, impartial group set up specifically to monitor a clinical trial (or other study) throughout its duration to determine where continuation of the study is appropriate scientifically and ethically.

Factors that Suggest a Data Safety Monitoring Board (DSMC/B) is Needed
  • A large study population.
  • Multiple study sites. It is more difficult to recognize a pattern of increased or unusual problems when investigators treat small fractions of the population separately.
  • Highly toxic therapies or dangerous procedures.
  • High expected rates of morbidity or mortality in the study population.
  • High chance of early termination of the study.
DSMC/B Composition and Coordination of Functions with the IRB

The NCI guidelines set forth requirements for DSMC/B composition and function; note that it is required that a majority of the members be drawn from outside the institution conducting the study. Membership is usually comprised of experts in the fields of medicine and science that are applicable to the study, statistical experts, lay representatives, and others who can offer an unbiased assessment of the study progress.

The DSMC/B should ensure that important safety information get to the IRB in a timely manner: "The study leadership will provide information on cumulative toxicities and relevant recommendations to the local principal investigators, to be shared with their IRBs."

Data Safety Monitoring Requirements

The MCW/Froedtert Hospital IRB follows guidelines set out by the National Cancer Institute (NCI), as they are the most comprehensive of the NIH guidelines. The NIH (NCI model) says that "All clinical trials supported or performed by NCI require some form of monitoring. "Risk and complexity are identified as the most important determinants of the degree and method of monitoring.

Early studies (non-therapeutic, Phase I, Phase II) are allowed great flexibility in monitoring; it is specifically allowed that the PI do the monitoring. However, the policy requires written policies and procedures, and also requires that "regardless of the method used, monitoring must be performed on a regular basis."

All Phase-III studies require a formal DSM plan, which may mean the establishment of a Data Safety Monitoring Board (DSMB) at the sponsoring institute or at the study site or at the lead institution of a multi-center trial. Note: Low-risk behavioral and nutritional trials may not require a DSMB.

Resources for Data Safety Monitoring
National Institutes of Health – Policies and Guidance

(Draft) Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees

Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials
June 5, 2000

NIH Policy for Data and Safety Monitoring
June 10, 1998

National Institutes of Health – Guidance by Institute

NCCAM Data and Safety Monitoring Board Guidelines for NCCAM-Supported Clinical Trials

National Eye Institute Funding News

National Heart, Lung, and Blood Institute: Policy for Data and Safety Monitoring of Extramural Clinical Studies

National Heart, Lung, and Blood Institute: Human Subjects Research

National Institute of Diabetes and Digestive and Kidney Diseases: Research and Funding for Scientists

National Institute on Aging: Research and Funding

National Institute of Allergy and Infectious Diseases: NIAID Clinical Terms of Award

National Institute of Arthritis and Musculoskeletal and Skin Diseases: Data and Safety Monitoring Guidelines

Eunice Kennedy Shriver National Institute of Child Health and Human Development: Grants & Funding


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