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