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changes.mady.by.user Jozef Aerts

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changes.mady.by.user Lex Jansen

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Element NameStudyEventDef
Parent
Element(s)
ElementsMetaDataVersion
Element XPath(s)/ODM/Study/MetaDataVersion/StudyEventGroupDef 
Element Textual ValueNone
UsageConditional. Required when a StudyEventGroupDef includes a StudyEventGroupRef child element.
AttributesOID, Name, Repeating,Type, Category, CommentOID
Child Elements

(Description?,  ItemGroupRef*, WorkflowRef?,

Coding

Coding*, Alias*)


Usage/Business Rules
  • Other Information:
    • The WorkflowRef references a workflow definition, a WorkFlowDef.
    • Scheduled study events correspond to sets of data collection instruments that are expected to be completed for each subject as part of the planned visit sequence for the study. Unscheduled study events are designed to collect data that may or may not occur for any particular subject (e.g., data collected for an early termination due to a serious adverse event). A common study event is a collection of data collection instruments that are used at several different data collection events such as an Adverse Event or Concomitant Medications log.