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  • Begin Date:  the date the adverse event began
  • End Date:  the date the adverse event ended (if applicable)
  • Seriousness:  the seriousness of the adverse event
  • Causality:  if the adverse event is related to the study
  • Resolved
  • Immediate Reporting Required
  • Event Expected
  • Description:  enter a brief description of the adverse event (up to 80 characters)
  • Details:  an optional field with no limit on the length

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