NIH requires a DSMP for all clinical trials and a DSMB for Phase 3 or otherwise high-risk trials. The plan should be proportionate to the trial's risk, complexity, and population.
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Glossary Term
Data and Safety Monitoring Plan (DSMP)
Data & Safety
Also known as: DSMP, data and safety monitoring plan
The written plan describing how a study will monitor safety data, report adverse events, and act on safety signals.
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