title: Evaluating and implementing data and safety monitoring plans.
abstract: Data and safety monitoring plans are essential for fulfilling assurances that are given to patients enrolling in clinical trials that they will not be exposed to avoidable risks and that any information that may influence their willingness to participate in the clinical trial will be made available to them whether the clinical trial is a phase I, phase II, or phase III effort. In addition to the often explicitly detailed nomination of members of an independent data and safety monitoring board and selection of interim analysis plans for control of type I error and avoidance of conduct of a futile study, data and safety monitoring requires organization with regard to schedules for data collection, active surveillance for adverse events, with special emphasis on serious or unexpected events, and the ability to bring all information within a study and newly accruing information external to the research project together as needed for assessment of patient safety.
authors.affiliation: Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Howard Hall, Suite 200, 660 West Redwood Street, Baltimore, MD 21201, USA. mterrin@epi.umaryland.edu
authors.forename: Michael L
authors.initials: ML
authors.lastname: Terrin
mesh_terms: D026661:Clinical Trials Data Monitoring Committees; D002986:Clinical Trials as Topic / Q000009:adverse effects / Q000379:methods* / Q000706:statistics & numerical data; D003625:Data Collection; D006801:Humans; D009316:National Institutes of Health (U.S.); D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration