Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

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

  Image RemovedImage Added