/ODM/Study/MetaDataVersion/Protocol/StudyStructure/Epoch OID, NameElement Name Epoch Parent Elements StudyStructure Element XPath(s) Element Textual Value None Attributes Child Elements (Description?) Usage/Business Rules
Attribute Schema Datatype or Enumeration Usage Definition Business Rule(s) OID oid Required Unique identifier for the Epoch. Name name Required Human readable name of the study epoch. SequenceNumber positiveInteger Required Order of the Epoch
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.
The PlannedDuration attribute provides the planned or expected duration of the epoch in ISO-8601 duration format. For epochs that have envisaged durations with time windows, the DurationTimingConstraint under StudyTiming will be used.
Example
A study protocol Schedule of Activities will organize activites within study epochs. This example shows a Follow-Up epoch with a planned duration of 3 weeks.
<Epoch OID="EPOCH.FLUP" Name="Follow-up Epoch" SequenceNumber="3"> <Description> <TranslatedText xml:lang="en "Type="text/plain">Follow-up Epoch</TranslatedText> </Description> </Epoch>
