Definitely related adverse event

An adverse event that         

  • is a known effect of the drug, device, or procedure (e.g., listed in the protocol documents including IB, consent, publications)
  • follows an obvious sequence of time, from the drug’s administration, device’s implantation or activation, or procedure, for which the event is directly attributed to the administration, implantation, activation, or procedure
  • ceases with discontinuation of the drug, device, or procedure (and reoccurs on restarting)
  • includes data that was only collected for the study
  • included disturbing or upsetting questions that the subject was asked for the purpose of the research