Representing CDISC Conformance Checks

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Project Overview

  • Represent SDTM and ADaM validation rules in RDF
Implementation algorithms will not be represented

Project Team

Name Role Organization E-mail
Scott Bahlavooni Industry Co-Lead Biogen-Idec
Josephine Gough Industry Co-Lead Roche
Gary Walker Industry Participant Quintiles
Xiaopeng Li Industry Participant Celerion
Amy Klopman Industry Participant Genentech

Project Rationale

  • ADaM standard includes validation rules
  • Identifying all validation rules associated with a SDTM (ADaM) domain or variable is a non-trivial, manual task
  • Vendor-agnostic representation of SDTM validation rules

Project Deliverables

  • Define ontology for validation rules
  • Identify version(s) of SDTM/ADaM validation rules for representation
  • Represent SDTM/ADaM validation rules in RDF
  • Link the RDF representations to CDISC standards represented in RDF

Project Related Documents

Compiled list of validation rules for SDTM IG v3.1.2, SDTM IG v3.1.2, SEND IG v3.0 and ADaM IG v1.0.

Proposed Ontology


  • ValidationRule
  • ValidationRuleCategory (as a sub-class of mms:Classifier)
  • FM to research documentation

Predicates (of ValidationRule Class):

  • checkID: String literal
  • documentReference: Resource
  • documentReferenceText: String literal (this is the specific text in the document reference to which the rule refers…may need to think about a better way to model this)
  • mms:dataset: represent the Structural Group in the ADaM validation rule documentation
  • validationRuleCategory
  • mms:variableGrouping: Note, the wording in the ADaM validation rules differs slightly from the ADaM IG. This predicate may need to be re-evaluated during the modeling.
  • failureCriteria: String literal
  • failureMessage: String literal (remove)

ADaM Checks in TopBraid Upload Format (Draft)

Meeting Materials

Date Presentations Meeting Minutes
12-Nov-2013 NA
  • Discussed Outcome from CDISC Interchange
  • Will proceed with representation of ADaM validation rules in RDF
  • Will collaborate with CDISC SDS team regarding their efforts defining and representing SDTM validation rules (meeting to be held in early Dec)
  • Meeting to be held on 26-Nov to define ontology for representing validation rules.
26-Nov-2013 NA
  • Discussed ontology to represent validation rules (focused on ADaM rules)
  • See proposed ontology above.
  • Discussed representation of additional SDTM identifier, timing, and observation class variables in domains. Gary Walker provided a document of other variables in 3.1.2 domains. Need to consider representing this in the SDTM RDF representation.
  • SDS & FDA/PhUSE meeting on 04Dec
  • Next meeting 12Dec.
12-Dec-2013 NA
  • Debriefed team on meeting with CDISC SDS team
  • Continued discussion of ontology to represent validation rules
  • Will enhance representation of ADaM in RDF to include documentation sections such that the sections reference by the rules can be linked. The exercise will highlight the "modelability" of the IG.
  • Action Items:
  • Frederik to research representing documentation references in dublin core as well as look at what was done across the existing CDISC representations
  • Jo and Scott to review ADaM IG documentation references
  • Scott to put ADaM checks in upload format and send to team for review
  • Next meeting 19Dec.
21-Jan-2014 NA
  • Frederik and Jo modeled document references based on modeling of SDTM domain-level IG assumptions
  • Each team member will take 50 checks and represent the references for those checks in the same method. (Scott will convert FM/JG doc into a Google document.)
  • Project will continue to occur online and will not officially breakout at the CSS
  • Next meeting 28Jan.