Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

Element NameStudyTiming
Parent ElementsStudyTimings
Element XPath(s)/ODM/Study/MetaDataVersion/Protocol/StudyTimings/StudyTiming
Element Textual ValueNone
Usage/Business Rules
  • Required
  • Cardinality: 1 or more
AttributesOID, Name
Child Elements(AbsoluteTimingConstraint*, RelativeTimingConstraint*, TransitionTimingConstraint*, DurationTimingConstraint*)
AttributeSchema DataType
or EnumerationUsageDefinitionBusiness RulesOIDoidRequiredUnique identifier for the StudyTiming elementThe OID attribute for the  StudyTiming must be unique within the Study.NamenameRequiredHuman readable identifier for the StudyEndPoint  element.The Name must be unique within the set of  StudyTiming elements for the Study.

The StudyTiming element defines a timing constraint within the study, which can be an absolute timing constraint (e.g. start of the screening visit must be between 1 January 2022 and 31 December 2022),
a relative timing constraint (e.g. Visit 2 must be within 30 days after Visit 1 with a window of +/- 1 week), a transitiontiming constraint (timing constraint on a transition within a defined workflow),
or a duration timing constraint (e.g. the duration of Visit 2 is planned to take hours with a window of 30 minutes).