2006 European Interchange:

1
RCRIM Vocab CDISC CT Initiative Overview and
Update
2006 European Interchange RCRIM Meeting
Bron Kisler, CDISC Terminology Team Lead
2
Outline

• General Overview
• CDISC Terminology Initiative
• HL7 RCRIM Vocabulary
• The Home Stretch

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RCRIM Vocabulary
RCRIM Vocabulary Team (RCRIM Vocab) is an open
membership working team organized as a
cooperative effort between HL7 (RCRIM TC), CDISC
Terminology, NCI EVS and others
RCRIM Regulated Clinical Research Information
Management NCI EVS National Cancer Institute
Enterprise Vocabulary Services
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Nexus for Harmonization
EVS NCI Enterprise Vocabulary Services
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Shared Working Principles

• Define and support the terminology needs of the
  CDISC Models and RCRIM sponsored HL7 messages
• Evaluate and/or utilize available terminology 1st
• Ensure consistency of terminology recommendations
  within organizations (RCRIM CDISC)
• Consideration ofHarmonization with related,
  external vocabulary efforts by other
  organizations
• Ensure terminology recommendations suit
  international needs for global organizations and
  projects

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CDISC Terminology Initiative
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CDISC Terminology

• Develop terminology recommendations for all
  appropriate fields in the CDISC Models (SDTM 1st)
• CDISC Controlled Terminology Initiative includes
  diverse team of 32 active team members, including
  5 European representatives
• SDTM Package-1 Project 30 codelists more than
  250 controlled terms
• SDTM Package-2 Project 26 codelists (38
  analyzed) more than 1000 controlled terms
• Significant collaboration with NCI EVS throughout
  development, harmonization and delivery of
  terminology

SDTM Study Data Tabulation Model NCI EVS
NCI Enterprise Vocabulary Services
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Terminology Team(s)

• SDTM Package-1 sub-team
• Primary point of collaboration between CDISC
  NCI EVS
• 5 CDISC team members, including Andreas Gromen
  (Schering AG, Germany)
• 3 NCI team members (NCI EVS caDSR)
• SDTM Package-2 sub-teams, considering terminology
  for eight SDTM domains
• EG Domain (ECG Test Results)
• PE VS Domains (Physical Examinations Vital
  Signs)
• SC Domain (Subject Characteristics)
• Intervention Domains - CM / EX SU (Concomitant
  Medications / Exposure Substance Use)
• AE Domain (Adverse Events)

caDSR Cancer Data Standards Repository NCI
EVS NCI Enterprise Vocabulary Services
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SDTM Package-2 Terminology
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CDISC Terminology Development
Stage I Standard Definition/Team Initiation
Stage II (a-e) Standards Development/Review/V
1.0 Release

1. Initial Codelist and Terminology Development
2. Public Review / Vetting of Comments (1x or 2x?)
3. Analyze, Harmonize and Load in EVS (NCI
   Thesaurus)
4. Quality Assurance and Control Steps (2x)
5. Create CDEs and Incorporate in caDSR for
   production

Stage III Education Support
In Partnership w/ NCI EVS
Stage IV Updates Maintenance
caDSR Cancer Data Standards Repository
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Terminology Project Status

• SDTM Package-1 Project
• Stage I (team initiated)completed 2004
• Stage IIaIId (stds devel)completed 2005
• Stage IIe ? Stage III (training)Q2 2006
• SDTM Package-2 Project
• Stage I (team initiated)completed 2005
• Stage IIa (codelist devel)Q2 2006
• Stage IIb (public review)Q3 2006
• LBTESTCD / LBTEST Codelist
• Stage I (team initiated)completed 2005
• Stage IIa (codelist devel)completed 2005
• Stage IIb (public review)completed Q2 2006
• Stage IIc (load in NCI EVS)Q3 2006

Stages I, II, III defined on previous slide
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HL7 RCRIM Vocab
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RCRIM Vocab Process

• Vocabulary Development
• Communication via RCRIM Vocab List-sever and
  telecons
• Consideration for the needs of HL7 messages
  involving concepts of clinical researchpreviously
  developed (aECG, CTLab), under development and
  future
• Consideration of related vocabulary efforts
  undertaken by other groups involved in clinical
  research such as FDA, EMEA, ICH, NCI/NIH, etc.
• Consideration for the work of other standards
  organizations and vocabulary developers such as
  LOINC, SNOMED, NCI EVS, etc.

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RCRIM Vocab Process

• Harmonizing with CDISC
• Identify vocabulary requirements that overlap
  with CDISC as early as possible (LAB, ECG)
• RCRIM Vocab coordinated with CDISC through CDISC
  Terminology Team Leader
• Significant overlap of key team members
• HL7 harmonization proposal document drafted as
  soon as possible to facilitate review and
  harmonization process

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RCRIM Vocab Process

• Finalizing Recommendations
• Distribute harmonization proposals via RCRIM
  Vocab and RCRIM list-servers for review and
  feedback
• Coordinate with other HL7 Technical Committees
  (TC) and Special Interest Groups (SIG) as needed
• Seek consensus among affected RCRIM project team
  and RCRIM in general
• Finalize harmonization proposal and submit for
  consideration at HL7 Harmonization Meeting

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Recent Proposals

• Wheres Phil when you need him?
• Add Codes for RoleCode Domain ResearchSubjectRole
  Basis (Nov. 2005)
• Codes for New ActReason Domain
  ClinicalResearchReason (Nov. 2005)
• Codes for New ObservationInterpretation Domain
  ClinicalResearchExclusion (Nov. 2005)
• Create a ValueSet Containing LOINC Age Codes
• Proposed new domain codes SubjectBodyPosition
• Codes for New ObservationMethod Domain
  ECGCollection

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SDTM Harmonization w/ RCRIM
Interventions
Findings
Exposure
Labs
InclExcl
ConMeds
Vitals
SubjChar
Subst Use
ECG
PhysExam
PG
QS
HL7 Harmonization
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The Home Stretch
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Other Terminology on the Radar

• International WHO Data Registry and potential for
  CDISC terminology development
• CDISC/DCRI agreement to develop therapeutic area
  data standards (primarily terminology) for
  Cardiology and Tuberculosis, sponsored by NIH
• New SDTM Domains to be prioritized including
• - Imaging
• - Microbiology
• - Oncology
• - Pharmacogenomics
• - Pharmacokinetics
• Other terminology development initiatives?

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Keys to Success

• Effective working relationships with key industry
  stakeholders such as NCI EVS
• Refine processes, including collaboration
  processes, to ensure scalable terminology
  development
• Channeling terminology development directly
  through CDISC NCI EVS relationship
• Internal Communications within CDISC HL7/RCRIM
• External Communicationsgetting the word out to
  US and International community
• Education Training for User Community

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• Knowing is not enough
• we must apply.
• Willing is not enough
• we must do.
• - Goethe-

If you are interested in contributing to RCRIM
Vocab or the CDISC Terminology Initiative, please
contact
Bron W. Kisler bkisler_at_cdisc.org bkisler_at_earthlink
.net [phone]