RCRIM Vocab CDISC CT Initiative Overview and

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 HL 7 RCRIM Vocabulary The Home Stretch…

RCRIM Vocabulary Team (RCRIM Vocab) is an open membership working team organized as a cooperative effort between HL 7 (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 RCRIM EVS = NCI Enterprise Vocabulary Services

Shared Working Principles • Define and support the terminology needs of the CDISC Models and RCRIM sponsored HL 7 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 & ca. DSR) • 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) ca. DSR = Cancer Data Standards Repository NCI EVS = NCI Enterprise Vocabulary Services

SDTM Package-2 Terminology Interventions Findings Events Exposure Labs Incl. Excl AE Con. Meds Vitals Subj. Char Disp. Subst Use Phys. Exam ECG Med. Hist QS PG

CDISC Terminology Development Stage I: Standard Definition/Team Initiation Stage II (a-e): Standards Development/Review/V 1. 0 Release a) b) c) d) e) Initial Codelist and Terminology Development Public Review / Vetting of Comments (1 x or 2 x? ) Analyze, Harmonize and Load in EVS (NCI Thesaurus) Quality Assurance and Control Steps (2 x) Create CDEs and Incorporate in ca. DSR for production In Partnership w/ NCI EVS Stage III: Education & Support Stage IV: Updates & Maintenance ca. DSR = 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 2 2006 • SDTM Package-2 Project – Stage I (team initiated)…completed 2005 – Stage IIa (codelist devel)…Q 2 2006 – Stage IIb (public review)…Q 3 2006 • LBTESTCD / LBTEST Codelist – – Stage I (team initiated)…completed 2005 Stage IIa (codelist devel)…completed 2005 Stage IIb (public review)…completed Q 2 2006 Stage IIc (load in NCI EVS)…Q 3 2006 Stages I, III defined on previous slide

HL 7 RCRIM Vocab

RCRIM Vocab Process Vocabulary Development • Communication via RCRIM Vocab List-sever and telecons • Consideration for the needs of HL 7 messages involving concepts of clinical research…previously developed (a. ECG, 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 • HL 7 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 HL 7 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 HL 7 Harmonization Meeting

Recent Proposals Where’s Phil when you need him? • Add Codes for Role. Code Domain… Research. Subject. Role. Basis (Nov. 2005) • Codes for New Act. Reason Domain… Clinical. Research. Reason (Nov. 2005) • Codes for New Observation. Interpretation Domain… Clinical. Research. Exclusion (Nov. 2005) • Create a Value. Set Containing LOINC Age Codes • Proposed new domain & codes: Subject. Body. Position • Codes for New Observation. Method Domain ECGCollection

SDTM Harmonization w/ RCRIM Interventions Findings Events Exposure Labs Incl. Excl AE Con. Meds Vitals Subj. Char Disp. Subst Use Phys. Exam ECG Med. Hist QS PG HL 7 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 & HL 7/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 bkisler@cdisc. org bkisler@earthlink. net (850)225 -2766