1. 1 RCRIM Vocab-BRIDG Session Wednesday, Session Q2 19 September 2007

2. 2 Agenda 11:00–11:30 am (BRIDG Update) 11:30 am – 12:10 pm (Terminology Update) ISO / ICH Meeting in Brisbane SDTM Terminology Projects Key Harmonization Activities / CDISC INTRAchange Meeting 12:10–12:30 pm (CV & TB Project Report)

3. 3 BRIDG Update (Julie Evans, Smita Hastak)

4. 4 Terminology Update (ISO TC 215 Working Group 6 meeting in Brisbane)

5. 5 Terminology Update (SDTM Terminology Projects)

6. 6 Snapshot – CDISC/RCRIM Terminology Formalized CDISC Terminology Program in 2005 Combined HL7 RCRIM Vocab & CDISC Terminology teams to ensure common development and harmonization through joint process Primary Objective: to define and support the terminology needs of the CDISC models and RCRIM projects across the clinical trial continuum (e.g. SDTM → CDASH) Terminology activities comprised of 70+ team members, distributed across 4 project teams that include international representation Key Partnership with US National Cancer Institute Enterprise Vocabulary Services (NCI EVS)

7. 7 Primary Driver (Proposed Rule) The Food and Drug Administration is proposing to amend the regulations governing the format in which clinical study data and bioequivalence data are required to be submitted for new drug applications (NDAs), biological license applications (BLAs), and abbreviated new drug applications (ANDAs). The proposal would revise our regulations to require that data submitted for NDAs, BLAs, and ANDAs, and their supplements and amendments be provided in an electronic format that FDA can process, review, and archive. The proposal would also require the use of standardized data structure, terminology, and code sets contained in current FDA guidance (the Study Data Tabulation Model (SDTM) developed by the Clinical Data Interchange Standards Consortium) to allow for more efficient and comprehensive data review. Federal Register / Volume 71, No. 237 / dated… Monday, December 11, 2006

8. 8 SDTM Package-1: 30 code lists & more than 700 controlled terms – Now in production http://www.cancer.gov/cancertopics/terminologyresources/ Labtest: single code list with 92 controlled terms – Now in production 250+ additional Analyte terms in development and available for public review this month SDTM Package-2A: 12 code lists & more than 600 controlled terms for ECG, Con Meds, Drug Exposure and Substance Use, including Units of Measure and Frequency – completed Public Review SDTM Package-2B: 17 code lists & 1000+ controlled terms for AE, Physical Exam, Vital Signs and Subject Chars, including Anatomical Location – in development SDTM Terminology Projects

9. 9 Core Working Principles Evaluate and/or utilize existing terminology 1 st Expand existing vocabularies where incomplete, working with vocabulary developer / owner Harmonize across CDISC Models and with pre- existing vocabulary initiatives (via RCRIM) Ensure terminology recommendations suit international needs for global organizations and projects Ensure a controlled and sustainable “open source” environment and infrastructure for production terminology supporting terminology evolution

10. 10 Collaboration with NCI EVS NCI Enterprise Vocabulary Services (EVS) has committed expertise and dedicated resources and is making a significant investment in the CDISC Terminology Program as well as RCRIM and FDA Vocabulary Initiatives (SPL, ICSR, RPS, CDRH Healthcare Devices) CDRH = Center for Devices and Radiological Health RCRIM = Regulated Clinical Research Info. Management

11. 11 Controlled Terminology “Nexus” Vocabulary Developers FDA & Academia Global Pharma & CROs International SDOs Health Level Seven (RCRIM TC)

12. 12 1. General: established processes for terminology development, harmonization and production; CDISC INTRAchange Meeting in July 2. CDISC Glossary: being loaded into terminology production environment (EVS) with SDTM terms 3. CDASH: aligning SDTM terminology projects with CDASH requirements…full harmonization planned for Q1 2008 4. SEND: gap analysis with SDTM underway and joint development activities launched this month 5. BRIDG/Protocol: harmonization activities being coordinated via RCRIM Technical Committee 6. Global activities…ISO/ICH and possibly WHO SEND = Standard for Exchange of Non-clinical Data CDASH = Clinical Data Acquisition Standards Harmonization Harmonization Activities

13. 13 CDASH-SDTM Terminology CDASH “Streams” SDTM Term. “Projects” CDASH Package-1 CDASH Package-1 SubjChars ConMedsAE Demog PE/VS MedHxIncl/Excl SubstUse ProtDevs Disp.EndStudy DrugExp LabECG CDASH Package-2 CDASH Package-2 CDASH Package-3 CDASH Package-3 CDASH Package-4 CDASH Package-4 SDTM Package-1 SDTM Package-1 * IN PRODUCTION * 30 Terminology code lists broadly distributed across SDTM * IN PRODUCTION * 30 Terminology code lists broadly distributed across SDTM SDTM Labtest SDTM Labtest * IN PRODUCTION * 1 Terminology code list with 100 terms; 200+ terms in devel. * IN PRODUCTION * 1 Terminology code list with 100 terms; 200+ terms in devel. SDTM Package-2A SDTM Package-2A PUBLIC REVIEW (closed) ECG, ConMeds, Drug Exp and Subst Use PUBLIC REVIEW (closed) ECG, ConMeds, Drug Exp and Subst Use SDTM Package-2B SDTM Package-2B IN DEVELOPMENT PE / VS, SubjChars, AE and Race IN DEVELOPMENT PE / VS, SubjChars, AE and Race In development

14. 14 Terminology Priorities (2007-early 2008) Finalize production release of Labtest, SDTM Package 2A and SDTM Package 2B terminology sets Support HL7 RCRIM-specific projects (Lab-based AE Assessment, Pharmacy SIG-CHI activities) and other projects related to global disease-specific data standards (e.g. CV, TB) Scope, support and harmonize with other priority projects – CDASH, SEND, BRIDG, etc… Harmonize with and support new global terminology projects such as those initiated by ISO, ICH & WHO Develop user guidelines for production terminology access, download and implementation & develop process for terminology change control

15. 15 CV & TB Project Update (Brian McCourt, Anita Walden)