Versions Compared

Key

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

Body:

...

Reference data provides information on how to interpret clinical data. For example, reference data might include lab normal ranges. Signature elements nested within ReferenceData have no meaning, and should be ignored.

...

Note: Since reference data can be independent of any particular study, it may be desirable to keep the reference metadata separate from clinical metadata. This can be done by creating a Study element with no Protocol, StudyEventDef, or FormDef elements. All the ItemGroupDefs would have IsReferenceData=Yes. Such a study would have no clinical data.

Include Page
ReferenceData Element
ReferenceData Element
Include Page
ReferenceData Attributes
ReferenceData Attributes

Pagenav2