MCW Data Safety Monitoring for Research

Information on formal ongoing monitoring of data to ensure that research subjects will be protected.

The investigator is responsible for determining if a study needs formal ongoing monitoring of data to ensure that research subjects will be protected. The IRB is responsible for review and evaluation of the plan to ensure the adequacy of the Data Safety Monitoring Plan in relationship to the size, complexity, and level of risk of the proposed research. These responsibilities stem 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.

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Factors that Suggest a Data Safety Monitoring Board 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.

Data Safety Monitoring Requirements

The MCW 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.

Data Safety Monitoring 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

Resources for Data Safety Monitoring

National Institutes of Health – Policies and Guidance

National Institutes of Health – Guidance by Institute