Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
AttributeSchema Datatype or EnumerationUsageDefinitionBusiness RulesRule(s)
StudyEventGroupOIDoidrefRequiredReference to the StudyEventGroupDef.
  • The StudyEventGroupOID value must match the OID attribute for a StudyEventGroupDef in this Study/MetaDataVersion.
  • The StudyEventGroupRefs within a Protocol must not have duplicate StudyEventGroupOID values.
Mandatory(Yes | No)RequiredIndicator of whether this StudyEventGroup must appear in the study clinical data for each subject per the study protocol.
  • When the value is Yes, the data for each subject in the study must include a StudyEventData element with this StudyEventGroupOID.
OrderNumberpositiveIntegerOptionalIndicates the order in which this StudyEventGroup appears in Metadata displays or data entry applications.OrderNumber should be a positive integer.
  • The StudyEventGroupRefs within a Protocol must not have duplicate OrderNumber values.
CollectionExceptionConditionOIDoidrefOptionalReference to a ConditionDef
  • The CollectionExceptionConditionOID value must match the OID attribute for a ConditionDef in this Study/MetaDataVersion.