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Guidelines for establishing and operating a Data and Safety Monitoring Board (DSMB)
Study Admission Data
Unblinded Clinical Trial Data
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 NIH Clinical Trial Definition - A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. See more at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html
 Site IRBs are responsible for ensuring adequate and appropriate operation of locally (site)-appointed DSMBs.
 Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect. Other important medical events, based upon appropriate medical judgment, may also be considered Serious Adverse Events if a trial participant's health is at risk and intervention is required to prevent an outcome mentioned.
 Unfavorable changes in health, including abnormal laboratory findings, that occur in trial participants during the clinical trial or within a specified period following the trial. Two types of adverse event data are to be reported: "Serious" and "Other (Not Including Serious)" adverse events.