Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Element NameDurationTimingConstraint
Parent Element(s)StudyTiming
Element XPath(s)
  • /ODM/Study/MetaDataVersion/Protocol/StudyTimings/StudyTiming/RelativeTimingConstraint
Element Textual ValueNone
Usage
AttributesOID, Name,
 StruturalElementOID
StruturalElementOID, DurationTarget, DurationPreWindow,
DurationPreWindow
DurationPostWindow
Child Elements
NoneAttributeSchema Datatype or EnumerationUsageDefinitionBusiness RulesOIDoidRequiredNamenameRequiredStruturalElementOIDoidrefRequiredOID of a structural element such as a Study, Epoch, StudyEventGroup, StudyEvent, ItemGroup, ItemDurationTargetdurationDatetimeRequiredDurationPreWindowdurationDatetimeOptionalDurationPreWindowdurationDatetimeOptional

Contained in:

...

The element DurationTimingConstraint is used to constraint the time duration of an activity within a clinical study (or the clinical study itself), represented by any of Study, Epoch, StudyEventGroupDef, StudyEventDef, ItemGroupDef, ItemDef.

The DurationTarget represents the envisaged time duration of the structural element. The value of DurationTarget must be a non-negative duration in ISO8601 format.

The DurationPreWindow describes the amount of time, expressed as a non-negative ISO 8601 duration, to which the activity may take less time than the envisaged duration provided in DurationTarget.

The DurationPostWindow describes the amount of time, expressed as a non-negative ISO 8601 duration, to which the activity may take more time than the envisaged duration provided in DurationTarget.

For example, if an epoch is envisaged to take 6 months, with a minimum of 5 months, and a maximum of 10 months, than DurationTarget="P6M", DurationPreWindow="P1M", and DurationPostWindow="P4M", with the value of StructuralElementOID being equal to the value of the OID attribute of the Epoch to which the constraint should be applied.

DurationTimingConstraint may not be used to describe timing constraints between structural elements such as e.g. visits, but can be used to described to the allowed duration of the visit itself (or any other activity).

...

(Description?)
Usage/Business Rules