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AttributeSchema Datatype or EnumerationUsageDefinitionBusiness
Rules
Rule(s)
OIDoidRequiredUnique identifier for the StudyEventDef element.
  • The OID attribute value must be unique within the Study/MetaDataVersion.
NamenameRequiredHuman readable-name for the
Study Event
study event.
  • The Name attribute must be unique within StudyEventGroupDef and StudyEventDef elements within a Study/MetadataVersion.
Repeating(Yes,No)Required
Indicates whether  SubjectData may include multiple StudyEventData  for this StudyEventDef. 

The Repeating flag indicates when this type of study event can occur repeatedly within any given subject.

When Repeating is "Yes" multiple instances of StudyEventData for this StudyEventDef may be collected for a study subject.


Type(Scheduled,Unscheduled,Common)Required

Specifies the StudyEvent Type.

 

The study protocol document usually specifies the planned set of study subject encounters, as follows:

Scheduled -  StudyEvent is a planned study event

Unscheduled  - Unplanned study event (for example an

unexpect

unexpected adverse event that occurs between planned visits.

Common - A set of study activities that occur for as part of all subject encounters within a study.

The study protocol document usually specifies the planned set of study subject encounters.

CategorytextOptional
May be used to further categorize or label study events
The Category attribute is typically used to indicate the study phase appropriate to this type of study event. Examples might include screening, pretreatment, treatment, and follow-up.
CommentOIDoidrefOptionalReference to a sponsor comment or external document relevant to this StudyEvent definition.