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.
| Include Page |
|---|
| ReferenceData Element |
|---|
| ReferenceData Element |
|---|
|
| Include Page |
|---|
| ReferenceData Attributes |
|---|
| ReferenceData Attributes |
|---|
|
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.