Federal Guidance

NIH Guidance documents on DSMPs/DSMB

The NIH requires a 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.

NIH Institute Specific Data and Safety Monitoring Guidance



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