Data and Safety Monitoring Executive Committee

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.

NCI: Policy of the National Canceer Institute for Data and Safety Monitoring of Clinical Trials

NEI: National Eye Institute Guidelines for Data and Safety Monitoring of Clinical Trials

NHLBI Policy on Human Subjects Research Data and Safety Monitoring Plans

NHLBI Guidelines for Data Quality Assurance in Clinical Trials and Observational Studies

NHLBI Responsibilies of Data and Safety and Safety Monitoring Boards Appointed by Participating Institutions

NIA: Implementation of Policies for Human Intervention Studies