Clinical Research Glossary

Data Monitoring Committee/Data and Safety Monitoring Board (DMC/DSMB) Data Monitoring Committee/Data and Safety Monitoring Board (DMC/DSMB)

CDISC

An independent group of experts that reviews study data to make sure that patient safety is protected.

Example of Data Monitoring Committee/Data and Safety Monitoring Board (DMC/DSMB) in a sentence

A Data Monitoring Committee advises the study sponsor if any concerns about participant safety are found.

More Info

Data Monitoring Committees (DMCs) are also called Data and Safety Monitoring Committees (DSMC) or Data and Safety Monitoring Boards (DSMB).

Studies that are randomized controlled trials, higher risk, or enrolling vulnerable populations (eg. children) usually include DMCs to review the data at specific timepoints, especially for adverse events that can affect participant safety.

The DMC reviews unblinded data on a regular schedule and as needed until the end of the study and advises on next steps in the event of adverse event(s).

The DMC also looks at whether a study should be stopped early (for example, for safety reasons or if there is no benefit to the study treatment)

Other info to think about when joining a study

You may see or hear about a Data Monitoring Committee (DMC) if you are enrolled in a study that has one.

The DMC looks at all study data and may request that the study team give you important new information that is learned.

If there are any safety concerns, the DMC may advise that the study should be ended early.

Version 2.0 September 2024

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