Data and Safety Monitoring Plan

Researchers are required to develop a Data and Safety Monitoring Plan appropriate in scope to the anticipated risks of the research. The method and extent of monitoring may vary across different types of studies, depending on multiple factors, including the experimental design and complexity of the study (e.g., Phase I vs. Phase III trial vs. a descriptive psychosocial interview study), and the degree of risk to subjects. Various funding sources also may have additional requirements related to data and safety monitoring which must be considered.  For additional information, please refer to the DSMP guidance.