Allow Rule Types that include define-xml to start the dataset builder from define-xml (and not only from dataset).

[eljanssens]

Standard

CDISC SDTM/SDTMIG

Reference Rule ID(s)

CG0015

Conformance Rule ID(s) (if published in CORE)

CDISC.SDTMIG.CG0015

JIRA Ticket

https://jira.cdisc.org/browse/CORERULES-45?jql=project%20%3D%20CORERULES%20AND%20resolution%20%3D%20Unresolved%20AND%20text%20~%20%22CG0015%22%20ORDER%20BY%20priority%20DESC%2C%20updated%20DESC

Proposed Rule YAML

A# Variable: GEN
# Condition: Variable Core Status = Permissible and data is collected
# Rule: Variable present in dataset and ^= null
Authorities:
  - Organization: CDISC
    Standards:
      - Name: SDTMIG
        References:
          - Citations:
              - Cited Guidance: The sponsor does not have the discretion to exclude permissible
                  variables when they contain data.
                Document: IG v3.2
                Section: 4.1.1.5
            Origin: SDTM and SDTMIG Conformance Rules
            Rule Identifier:
              Id: CG0015
              Version: '1'
            Version: '2.0'
        Version: '3.2'
      - Name: SDTMIG
        References:
          - Citations:
              - Cited Guidance: The sponsor does not have the discretion to exclude permissible
                  variables when they contain data.
                Document: IG v3.3
                Section: 4.1.5
            Origin: SDTM and SDTMIG Conformance Rules
            Rule Identifier:
              Id: CG0015
              Version: '1'
            Version: '2.0'
        Version: '3.3'
      - Name: SDTMIG
        References:
          - Citations:
              - Cited Guidance: If a study includes a data item that would be represented in a
                  Permissible variable, then that variable must be included in
                  the SDTM dataset, even if null.
                Document: IG v3.4
                Section: 4.1.5
            Origin: SDTM and SDTMIG Conformance Rules
            Rule Identifier:
              Id: CG0015
              Version: '1'
            Version: '2.0'
        Version: '3.4'
Check:
  all:
    - name: define_variable_name
      operator: non_empty
    - name: library_variable_core
      operator: equal_to
      value: Perm
    - name: define_variable_has_no_data
      operator: empty
    - any:
        - name: variable_name
          operator: not_exists
        - name: variable_is_empty
          operator: equal_to
          value: 'Yes'
Core:
  Id: CDISC.SDTMIG.CG0015
  Status: Draft
  Version: '1'
Description: Raise an error when a variable is permissible, data is collected as
  per define-xml document but variable is not present in the dataset or has no
  data.
Executability: Fully Executable
Outcome:
  Message: 'Variable is permissible and data is collected as per define-xml
    document but variable is not present in the dataset or variable has no
    data.'
  Output Variables:
    - library_variable_name
    - library_variable_core
    - define_variable_name
    - define_variable_has_no_data
    - variable_name
    - variable_is_empty
Rule Type: Variable Metadata Check against Define XML and Library Metadata
Scope:
  Classes:
    Include:
      - ALL
  Domains:
    Include:
      - ALL
Sensitivity: Record

Attach any sample test data file(s)

Available on SharePoint: https://cdisc.sharepoint.com/sites/CORERules/Shared%20Documents/Forms/AllItems.aspx?id=%2Fsites%2FCORERules%2FShared%20Documents%2FunitTesting%2FSDTMIG%2FCG0015&viewid=ecd009a9%2Db73b%2D415b%2D9e41%2Df9d04a69edf4&FolderCTID=0x012000DB2B68AD3779324A8BE66373AE3E0E60

Expected output

sv.xpt - VISIT (in define but missing in dataset) - SVENDY & SVUPDES (in define and in dataset but completely empty)
tv.xpt - VISIT and TVENRL (in define and in dataset but completely empty)

Any Additional Information

Discussed with Gerry and Sam previously and this would mean enabling an outer join.