Glossary Term

Data and Safety Monitoring Plan

Glossary Term:

Data and Safety Monitoring Plan


Data and Safety Monitoring means the process to ensure and maintain the scientific integrity of human subject research and to protect the safety of human subjects, a system for appropriate oversight and monitoring to ensure the safety of participants and the validity of the data. The section of a protocol that describes the steps to identify physical, social, or psychological occurrences that may result from participation in the research study and explains in detail how such occurrences will be handled and reported. A DSMP describes the timing, tools and/or method(s) for monitoring and evaluation, procedures for treatment or resolution (including circumstances which would result in halting or terminating research), procedures for and timing of reports to oversight bodies, and description of oversight bodies involved with the study (e.g. FDA, IRB, or Data and Safety Monitoring Board). A study does not need to have a Data and Safety Monitoring Board to have a DSMP.

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