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.
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