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2006 European Interchange: RCRIM Meeting

RCRIM Vocab & CDISC CT Initiative: Overview and Update. 2006 European Interchange: RCRIM Meeting. Bron Kisler, CDISC Terminology Team Lead. Outline. General Overview CDISC Terminology Initiative HL7 RCRIM Vocabulary The Home Stretch…. RCRIM Vocabulary.

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2006 European Interchange: RCRIM Meeting

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  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…

  3. 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

  4. RCRIM Nexus for Harmonization EVS = NCI Enterprise Vocabulary Services

  5. 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 of…Harmonization with related, external vocabulary efforts by other organizations • Ensure terminology recommendations suit international needs for global organizations and projects

  6. CDISC Terminology Initiative

  7. 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

  8. 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

  9. Interventions Findings Events Exposure Labs InclExcl AE ConMeds Vitals SubjChar Disp. Subst Use PhysExam ECG MedHist QS PG SDTM Package-2 Terminology

  10. CDISC Terminology Development Stage I: Standard Definition/Team Initiation Stage II (a-e): Standards Development/Review/V 1.0 Release • Initial Codelist and Terminology Development • Public Review / Vetting of Comments (1x or 2x?) • Analyze, Harmonize and Load in EVS (NCI Thesaurus) • Quality Assurance and Control Steps (2x) • 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

  11. Terminology Project Status • SDTM Package-1 Project • Stage I (team initiated)…completed 2004 • Stage IIa–IId (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

  12. HL7 RCRIM Vocab

  13. RCRIM Vocab Process Vocabulary Development • Communication via RCRIM Vocab List-sever and telecons • Consideration for the needs of HL7 messages involving concepts of clinical research…previously 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.

  14. 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

  15. 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

  16. Recent Proposals Where’s Phil when you need him? • Add Codes for RoleCode Domain… ResearchSubjectRoleBasis (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

  17. Events AE Disp. MedHist SDTM Harmonization w/ RCRIM Interventions Findings Exposure Labs InclExcl ConMeds Vitals SubjChar Subst Use PhysExam ECG QS PG HL7 Harmonization

  18. The Home Stretch…

  19. 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?

  20. 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 Communications…getting the word out to US and International community • Education & Training for User Community

  21. 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@cdisc.org bkisler@earthlink.net (850)225-2766

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