Subject data set

Data Series Title	Description	Location in Oracle Argus Safety
NameInitials	Patient initials.	Case Form / Patient / Patient Information / Initials
BirthDateTime	Patient date of birth.	Case Form / Patient / Patient Information / Date of Birth
OnsetAge	Age at the time of onset of the reaction.	Case Form / Patient / Patient Information / Age
OnsetAgeUnit	Unit for the age at time of onset of the reaction (for example, years, months).	Case Form / Patient / Patient Information / Age Units
GestationPeriod	Gestation period when the adverse event was observed in the fetus.	Case Form / Patient / Patient Information / Pregnancy Details / Weeks at Onset If a valid value is entered, the Pregnant field is selected as well.
GestationPeriodUnit	Unit for the gestation period (weeks, months, trimester).	Case Form/ Patient / Patient Pregnancy Details / Weeks at Onset If a value is entered, the Pregnant field is selected.
AgeGroupCode	Patient age group (for example, adolescent, adult).	Case Form / Patient / Patient Age Group
Weight	Patient weight.	Case Form / Patient / Weight
WeightUnit	Unit for the patient weight (for lb, kg).	Case Form / Patient / Patient Weight Oracle Argus Safety requires kg. If you collect weight in pounds, set the study design to perform the conversion to kg.
Height	Patient height.	Case Form / Patient / Patient Height
HeightUnit	Unit for the patient height (for in, cm).	Case Form / Patient / Patient Height Oracle Argus Safety requires cm. If you collect height in inches, set the study design to perform the conversion to cm.
SexCode	Patient gender	Case Form / Patient / Patient Gender
LastMenstrualDateTime	Date of the last menstrual period the adverse event occurred.	Case Form / Patient / Patient Date of LMP
MedicalHistory	Text item used to summarize the history and concurrent conditions of patient.	Case Form / Patient / Notes
InvestigationResult	Results of tests and procedures to the investigation of the patient. Map this data series when structured information is not available.	Case Form / Patient / Relevant Test
RaceCode	Patient race.	Case Form / Patient / Patient Ethnicity
BreastFeedingIndicator	Indicates whether the patient breast feeds an infant.	Case Form / Patient / Patient Details / Breastfeeding
OccupationCode	Occupation of the patient.	Case Form / Patient / Patient Details / Occupation
PregnancyDueDateTime	Due date for the pregnancy.	Case Form / Patient / Pregnancy Due Date
ProspectiveIndicator	Whether the sponsor was aware of the pregnancy before the birth.	Case Form / Patient / Pregnancy Prospective
RetrospectiveIndicator	Whether the sponsor became aware of the pregnancy after the birth.	Case Form / Patient / Pregnancy Retrospective
FetusCount	Number of fetuses in the pregnancy.	Case Form / Patient / Pregnancy Fetus Count