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StudyEventDef represents the definition of an activity in a study where data is collected. For example, a study event may represent a set of item groups that represent data collection instruments to be completed for a subject during a visit in a study. The visit occurs as part of a study workflow, and the workflow is referenced in the study event.


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

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.


Element NameStudyEventDef
Parent ElementsMetaDataVersion
Element XPath(s)/ODM/Study/MetaDataVersion/StudyEventGroupDef 
Element Textual ValueNone
AttributesOID, Name, Repeating,Type, Category, CommentOID
Child Elements

(Description?,  ItemGroupRef*, WorkflowRef?, 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.

AttributeSchema Datatype or EnumerationUsageDefinitionBusiness 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.
  • The Name attribute must be unique within StudyEventGroupDef and StudyEventDef elements within a Study/MetadataVersion.
Repeating(Yes,No)Required

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 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.


CategorytextOptionalThe 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.

StudyEventDef
<!-- StudyEventDef example, referencing one ItemGroupDef that represents a form,
    and one ItemGroupDef that represents a lab transfer -->
<StudyEventDef OID="SE.EXAMPLE" Name="Example StudyEvent" Repeating="Yes" Type="Scheduled">
    <Description>
        <TranslatedText xml:lang="en" Type="text/plain">StudyEventDef example, referencing one ItemGroupDef that represents a form,
            and one ItemGroupDef that represents a lab transfer</TranslatedText>
    </Description>
    <!-- ItemGroup representing a form, with a header section and data section -->
    <ItemGroupRef ItemGroupOID="IG.FORM" Mandatory="Yes"/>
    <!-- ItemGroup representing a lab transfer -->
    <ItemGroupRef ItemGroupOID="IG.LAB" Mandatory="No"/>    
</StudyEventDef>
    
<!-- ItemGroup representing a form, with a header section and data section, 
    i.e. the ItemGroup-s are "nested" -->
<ItemGroupDef OID="IG.FORM" Name="Data collection form" Repeating="No" Type="Form">
    <!-- The form consists of two sub-forms, a header with subject, site and investigator data,
    and a data collection sub-form. -->
    <ItemGroupRef ItemGroupOID="IG.FORM.HEADER" Mandatory="Yes"/>
    <ItemGroupRef ItemGroupOID="IG.FORM.DATACOLLECTION" Mandatory="Yes"/>
</ItemGroupDef>
    
<!-- "Header" subform -->
<ItemGroupDef OID="IG.FORM.HEADER" Name="Form header" Repeating="No" Type="Section">
    <ItemRef ItemOID="IT.SUBJECTID" Mandatory="Yes"/>
    <ItemRef ItemOID="IT.SITEID" Mandatory="Yes"/>
    <ItemRef ItemOID="IT.INVESTIGATORID" Mandatory="Yes"/>
</ItemGroupDef>
    
<!-- Data collection subform, not further specified here -->
<ItemGroupDef OID="IG.FORM.DATACOLLECTION" Name="Data collection sub-form" Repeating="No" Type="Section">
    ...
</ItemGroupDef>
    
<!-- ItemGroup representing a lab transfer -->
<ItemGroupDef OID="IG.LAB" Name="Lab transfer" Repeating="No" Type="Dataset" Type="Section">
    <!-- The ItemRefs may e.g. define the fields in a lab transfer CSV file -->
    ...    
</ItemGroupDef>

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