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Evaluating and Implementing Data and Safety Monitoring Plans
  1. Michael L. Terrin
  1. From the Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Baltimore, MD.
  2. Address correspondence to: Dr. Michael L. Terrin, University of Maryland School of Medicine, Howard Hall, Suite 200, 660 West Redwood Street, Baltimore, MD 21201; e-mail: mterrin{at}epi.umaryland.edu.

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.

Key Words
  • clinical trials
  • data and safety monitoring plan
  • patient safety
  • monitoring

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