Data and Safety Monitoring

Data and safety monitoring (DSM) refers to a set of oversight procedures in research studies involving human subjects. Depending on the nature and complexity of the study, DSM is carried out not just during the study but often before and after it as well.

Data monitoring refers to the oversight of the research data to help ensure their validity and integrity and to determine whether and to what extent they adequately serve the goals of the study and subject safety. For instance, in a clinical trial designed to test whether a given drug is more effective than placebo in reducing heart attack rates, the plan for data collection must be scrutinized for its appropriateness to achieve study goals before the study even begins. During the study, ...