Safety_Case data set

in the Safety_Case data set

Data Series Title	Description	Location in Argus Safety
SeriousIndicator	Whether the case is serious.	Case Form / Analysis / Case Serious
OccurenceCountryCode	Where the adverse event occurred.	Case Form/ General / General Information / Country of Incidence
SeriousnessDeathIndicator	Whether the case resulted in death.	Case Form / Analysis / Case Serious / Notes
SeriousnessLifeThreatening Indicator	Whether the case is life threatening.	Case Form / Analysis / Case Serious / Notes
SeriousnessHospitalization Indicator	Whether the case requires inpatient hospitalization or prolonging of existing hospitalization.	Case Form / Analysis / Case Serious / Notes
SeriousnessDisablingIndicator	Whether the case results in persistent or significant disability or incapacity.	Case Form / Analysis / Case Serious / Notes
SeriousnessCongenital AnomalyIndicator	Whether the case results in a congenital anomaly or birth defect.	Case Form / Analysis / Case Serious / Notes
SeriousnessOtherIndicator	Whether the case contains a medically important condition.	Case Form / Analysis / Case Serious / Notes
Narrative	An overall case narrative to send to the Oracle Argus Safety application. This data set can be mapped to multiple items on the SAE case form. The contents of all mapped items will be concatenated together in the order the items appear on the form. Items on the AE form that need to be part of the narrative must be mapped at the Subject_AdverseEvent level. These items will appear before any of the items mapped at this level in the narrative sent to Argus Safety. Compound items are not supported as a narrative field.	Case Form / Analysis / Case Analysis / Narrative