The planned period of subjects' participation in the trial is divided into sequential epochs. Each epoch is a period of time that serves a purpose in the trial as a whole. Epochs cannot overlap. The sequence of the epoch in the study is provided by the SequenceNumber attribute, the first epoch in the study being assigned the sequence number 1. Sequence numbers are subsequent.

Element NameEpoch
Parent ElementsStudyStructure
Element XPath(s)

/ODM/Study/MetaDataVersion/Protocol/StudyStructure/Epoch

Element Textual ValueNone
Attributes

OID, Name

Child Elements(Description?)
Usage/Business Rules


AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rule(s)
OIDoidRequiredUnique identifier for the Epoch.
  • The Epoch/@OID must be unique within the Study
NamenameRequiredHuman readable name of the study epoch. 
  • The Epoch/@Name must be unique within the Study.
SequenceNumberpositiveIntegerRequiredOrder of the Epoch 

Example: Epoch

A study protocol's schedule of activities organizes activities within study epochs. This example shows a follow-up epoch with a planned duration of 3 weeks.

Epoch
<Epoch OID="EPOCH.FLUP" Name="Follow-up Epoch" SequenceNumber="3">
    <Description>
     <TranslatedText xml:lang="en "Type="text/plain">Follow-up Epoch</TranslatedText>
    </Description>
</Epoch>



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