When is a Data and Safety Monitoring Board typically involved in a study?

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The Data and Safety Monitoring Board is an independent group that oversees participant safety and data integrity while the study is actively running. They review interim data at predefined times, monitor adverse events, and can recommend continuing as planned, modifying the protocol, or stopping the trial early if safety concerns arise or if results are clearly conclusive. This monitoring occurs during the trial as data are being collected, not after completion. Grant applications and initial protocol submissions are planning stages, not the period when ongoing safety review and data monitoring occur.