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Your First Application to the GCRC
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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.
The following table lists documents available from various NIH agencies.
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