An assessment regarding the causal relationship between a drug or intervention and an adverse event.
EVENTS RELATED
Definitely Related
- The event is a known effect of the drug, device, or procedure (e.g., listed in the protocol documents including IB, consent, publications)
- The event 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.
- The event ceases with discontinuation of the drug, device, or procedure (and reoccurs on restarting).
- The event includes data that was only collected for the study.
- The event included disturbing or upsetting questions that the subject was asked for the purpose of the research.
Probably Related
- The event is lesser known or suspected effect of the drug, device, or procedure (listed in the protocol documents including IB, consent, publications, etc.)
- The event follows a reasonable sequence of time from the drug’s administration, device implantation, activation, or procedure, for which the event may be attributed to the administration, implantation, activation, or procedure.
- The event ceases or diminishes with discontinuation of the drug, removal/discontinued activation of the device, or procedure.
Possibly Related
- The event is a lesser known or possible effect of the drug, device, or procedure.
- The event occurred within a sequence of time from the drug’s administration, device implantation and/or activation, or procedure, for which the event may be attributed to the administration, implantation, activation, or procedure.
- The event could be explained by the characteristics of the population under study.
EVENTS NOT RELATED
Unlikely Related
- The event is NOT a previously known or suspected effect of the test drug, device, or procedure.
- The event does NOT follow a sequence of time from drug administration, device implantation and/or activation, or procedure, for which the event could be attributed to the administration, implantation, activation, or procedure.
- The event can be readily explained by the characteristics of the population under study.
Unrelated
- The event is NOT known to be an effect of the test drug, device, or procedure.
- The event does NOT follow a sequence of time from drug administration, device implantation and/or activation, or procedure, for which the event could be attributed to the administration, implantation, activation, or procedure.
- The event can be readily and easily explained by the characteristics of the population under study.
- Subject never received study drug, study device, or underwent research study procedure.
