1. Update on CDISC Terminology Activities RCRIM Vocab Session (Q4) 14 January 2009, Orlando Bron Kisler (CDISC)

2. Terminology Snapshot Primary Objective: to define and support the terminology needs of the CDISC models across the clinical trial continuum (SDTM → CDASH) Focus on “standard” terminology codelist development and publication, beginning with SDTM version 3.1.1 Key partnership with US National Cancer Institute Enterprise Vocabulary Services (NCI EVS) with terms coded in NCI Thesaurus Contribute to external harmonization activities ISO, FDA, HL7 RCRIM, NCI, etc.

3. http://www.cancer.gov/cancertopics/terminologyresour ces/CDISChttp://www.cancer.gov/cancertopics/terminologyresour ces/CDISC SDTM Packages 1, 2A, 2B: 49 code lists with ~ 1750 controlled terms distributed across SDTM Labtest Packages 1 & 2: single code list with 365 controlled terms for Laboratory Test Results (commonly used for Analytes) SDTM Package 3: 6 code lists with 70 controlled terms, including Specimen Type and Specimen Condition; also includes 2 CDASH-specific code lists; finalized and being moved into production Labtest Package 3: Additional 180 controlled terms for Laboratory Test Results; finalized and being moved into production SDTMIG v3.1.1 Terminology (production ~2500 terms)

4. CDASH Clinical Data Acquisition Standards Harmonization: – CDASH Version 1.0 released October 2008 – With few exceptions, SDTM terminology aligned with CDASH requirements SEND Standards for the Exchange of Non- Clinical Data: – Gap analysis with SDTM Terminology complete; significant overlap and reuse of SDTM terminology – Novel terminology developed (~640 new “draft” terms) for SEND IG and regulatory pilots with focus on Species, Strains and Biospecimens Harmonization Activities …Internal

5. CDISC-FDA-NCI EVS Terminology Harmonization NCI Thesaurus http://www.cancer.gov/cancertopics/terminologyresources/ SDTM v3.1.1 CDASH, SEND SPL RPS, ICSR

6. ISO Technical Committee 215 WG-6 IDMP Projects; Units of Measurement – finalized 11240 CD ballot document HITSP Harmonization Subcommittee: Gender, Marital Status, Route of Administration, Body Site Joint Initiative Council (ISO, CEN, HL7, CDISC and now IHTSDO-SNOMED CT) FDA Projects (ICSR, RPS) Harmonization Activities …other

7. 2009 Terminology Plan Refer to and discuss accompanying 2009 Terminology Project spreadsheet for CDISC, RCRIM and FDA