Short Name |
QORIG Values Not Matching Define-XML v2.1 Origin Type Values
|
||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Affected Standard |
SDTMIG v3.3
SDTMIG v3.4
|
||||||||||||
Description of Error |
In SDTMIG v3.3 and SDTMIG v3.4 Section 4.1.8.1 Origin Metadata for Variables reads "The origin element in the Define-XML document file is used to indicate where the data originated. Its purpose is to unambiguously communicate to the reviewer the origin of the data source. For example, data could be collected (on the CRF, from a vendor, or from a device), derived, or assigned; CRF data should be traceable to an annotated CRF and derived data should be traceable to some derivation algorithm. The Define-XML specification is the definitive source of allowable origin values. Additional guidance and supporting examples can be referenced using the Metadata Submission Guidelines (MSG) for SDTMIG." Reason for Uncertainty: |
||||||||||||
Efforts to Correct Error |
|
||||||||||||
JIRA Issue |
Impact of Issue | Coping Strategy |
---|---|
None. Inconsistency between CDISC Notes for QORIG and QORIG examples. |
Users should set QORIG for their SUPP-- SDTM dataset variables equal to the values from the Define-XML specification Origin Type (i.e., either "Assigned", "Collected", "Derived", or "Protocol"). |