Element Name | Epoch |
---|---|
Parent Elements | StudyStructure |
Element XPath(s) | /ODM/Study/MetaDataVersion/Protocol/StudyStructure/Epoch |
Element Textual Value | None |
Usage/Business Rules | |
Attributes | OID, Name |
Child Elements | (Description?) |
Attributes ODM2DEV-58 - Getting issue details... STATUS :
Name | Attribute Reference | Notes | |
OID | oid | ||
Name | name | ||
SequenceNumber | positiveInteger | ||
PlannedDuration | durationDatetime | (optional) |
Contained in:
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.