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When are Data and Safety Monitoring Boards (DSMBs) needed?

NIH Guidance on When Data and Safety Monitoring Boards (DSMBs) are Needed

The NIH requires a data and safety monitoring board (DSMB) for Phase III clinical investigations (or any multi-site clinical trial) involving interventions that entail potential risk to participants. For phase I and II trials, a DSMB may be appropriate if the studies have multiple clinical sites, are blinded, or employ particularly high-risk interventions or vulnerable populations. The NCRR requires a DSMB for any investigation that places participants at significant risk.

Documents Available from NIH Agencies

NIHFurther Guidance On Data And Safety Monitoring For Phase I And Phase II Investigations
(Notice: OD-00-038, June 5, 2000)
NIHPolicy For Data And Safety Monitoring
(Notice: OD-98-084, June 10, 1998)
NCIEssential Elements of a Data and Safety Monitoring Plan for Clinical Investigations Funded by the National Cancer Institute
NH LBIPolicy for Data and Safety Monitoring of Extramural Clinical Studies
NH LBIData and Safety Monitoring FAQ's
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