Reference data provides information on how to interpret clinical data. For example, reference data might include lab normal ranges. For a study that uses CDISC standards, refence reference data might include SDTM Trial Design datasets.
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| ReferenceData Element |
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| ReferenceData Element |
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| ReferenceData Attributes |
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| ReferenceData Attributes |
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Implementation note: Because 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.