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Frequently Asked Questions From Applicants
Data and Safety Monitoring
Does my research need data and safety monitoring?
45 CFR 46.111(a)(6) states the following requirement for IRB approval of human subjects research:
“When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.”
Does my research need a Data and Safety Monitoring Plan?
The NIH Policy for Data and Safety Monitoring states that all NIH funded clinical trials require a Data and Safety Monitoring Plan and that monitoring should be commensurate with risk.
Most NIH Institutes/Centers have individual Data and Safety Monitoring policies. Click here for the links to I/C-specific policies.
Does my research need a Data and Safety Monitoring Board?
- Data and Safety Monitoring Boards (DSMBs) are specifically required for multi-site clinical trials with interventions that entail risk(s) to participants
- DSMBs are generally required for Phase III clinical trials
- A DSMB may be required for Phase I, Phase II or Phase III clinical trials if:
- The clinical trial is blinded
- The clinical trial involves high risk intervention(s), or
- The clinical trial includes vulnerable population(s)
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