Deep Dive
US Equity - Biotech
A "data safety monitoring plan" (DSMP) is a required document outlining how a clinical trial will monitor, participant safety, subject privacy, data integrity and confidentiality, and outlines criteria for making safety-related decisions. This plan must meet the overseeing regulatory guidelines usually by the The National Institutes of Health (NIH), The Office for Human Research Protection (OHR) or The U.S. Food and Drug Administration (FDA).
High-risk clinical trials, studies with potentially serious adverse events or involving vulnerable populations, may require an independent group of experts who actively review the data and provide recommendations regarding the safety and continuation of a clinical trial based on that plan. Phase II and Phase III clinical trials, especially when blinded, may require a "Data Safety Monitoring Board" (DSMB) as per rule 45-cfr-46.