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AttributeSchema Datatype or EnumerationUsageDefinitionBusiness
Rules
Rule(s)
StudyEventOIDoidrefRequiredReference to the StudyEventDef.
  • Must match the OID
atttribute
  • attribute for a StudyEventDef in the Study/MetaDataVersion.
Mandatory(Yes | No)Required
Indicator of whether this StudyEvent must appear in the study clinical data

The Mandatory flag indicates that the clinical data for the containing MetaDataVersion would be incomplete without an instance of this type of Study Event for each subject per the study protocol

.When the value is Yes, the

. ODM clinical data files that are incomplete in this sense may be considered incomplete for study review and analysis purposes.

  • The data for each subject in the study must include a StudyEventData element with this StudyEventOID, when the value is "Yes".
OrderNumber
integer
positiveIntegerOptional

Indicates the order in which this StudyEventDef appears in Metadata displays or data entry applications.

OrderNumber must be a positive integer

OrderNumbers provide an ordering on the StudyEventDefs for use whenever a list of StudyEventDefs is presented to a user. They do not imply anything about event scheduling, time ordering, or data correctness. Order of execution and timing between study events and groups of study events must be defined in WorkflowDef elements. Scheduling will be realized in StudyTiming and its child elements that reference StudyEventGroups.

  • The StudyEventRefs within a StudyEventGroup must not have duplicate OrderNumber values.
CollectionExceptionConditionOIDoidrefOptional

Reference to a ConditionDef

If the CollectionExceptionConditionOID attribute is provided, it references a ConditionDef that describes the circumstances under which data for this study event should not be collected.

  • The CollectionExceptionConditionOID value must match the OID attribute for a ConditionDef in this Study/MetaDataVersion.