QORIG Values Not Matching Define-XML v2.1 Origin Type Values

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."  

The issues are, that while SDTMIG variable notes and assumptions for QORIG (in 8.4.1 Supplemental Qualifiers – SUPP-- Datasets and throughout the IG) refer users to this section and thus the statement that the Define-XML is the "definitive source of allowable origin values", the values for QORIG in domain examples and CDISC notes for the variable do not match the values in the Define-XML specification.  Furthermore, with Define-XML the def:Origin element has 2 attributes "Type" and "Source", with the former being the values that should be used when populating QORIG.


Reason for Uncertainty:
Values of "CRF" and "eDT" in QORIG examples and notes in SDTMIG v3.3 and v3.4 should be interpreted as "Collected".  There are no conformance rules that check the values of QORIG other than CG0202 for SDTMIG v3.3 when QORIG = 'Assigned' and casing was addressed in SDTMIG v3.3 Errata.  CG0202 was retired for SDTMIG v3.4.

Efforts to Correct Error
IdentifierPossible solutionStage of Development
1QORIG has been eliminated in SDTMIG v4.0Drafted - Nearing Internal Review

 

Standards team addressing issueSDS SUPPtoNSV Subteam
Is team recruiting new volunteers to work on this issue?No
Standards version expected to include resolutionSDTMIG v4.0
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").