2006 European Interchange: RCRIM Meeting RCRIM Vocab & CDISC CT Initiative: Overview and Update Bron Kisler, CDISC Terminology Team Lead

Outline General Overview CDISC Terminology Initiative HL7 RCRIM Vocabulary The Home Stretch…

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

Nexus for Harmonization EVS = NCI Enterprise Vocabulary Services RCRIM

Shared Working Principles Define and support the terminology needs of the CDISC Models and RCRIM sponsored HL7 messages Evaluate and/or utilize available terminology 1 st 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

CDISC Terminology Initiative

CDISC Terminology Develop terminology recommendations for all appropriate fields in the CDISC Models (SDTM 1 st ) 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

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

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

Stage I: Standard Definition/Team Initiation Stage III: Education & Support Stage IV: Updates & Maintenance Stage II (a-e): Standards Development/Review/V 1.0 Release CDISC Terminology Development a) Initial Codelist and Terminology Development b) Public Review / Vetting of Comments (1x or 2x?) c) Analyze, Harmonize and Load in EVS (NCI Thesaurus) d) Quality Assurance and Control Steps (2x) e) Create CDEs and Incorporate in caDSR for production In Partnership w/ NCI EVS caDSR = Cancer Data Standards Repository

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)…Q SDTM Package-2 Project –Stage I (team initiated)…completed 2005 –Stage IIa (codelist devel)…Q –Stage IIb (public review)…Q LBTESTCD / LBTEST Codelist –Stage I (team initiated)…completed 2005 –Stage IIa (codelist devel)…completed 2005 –Stage IIb (public review)…completed Q –Stage IIc (load in NCI EVS)…Q Stages I, II, III defined on previous slide

HL7 RCRIM Vocab

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.

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

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

Recent Proposals Wheres 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

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

The Home Stretch…

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?

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

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 (850)