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

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

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

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  1. RCRIM Vocab-BRIDG SessionWednesday, Session Q219 September 2007

  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. BRIDG Update (Julie Evans, Smita Hastak)

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

  5. Terminology Update (SDTM Terminology Projects)

  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. Primary Driver(Proposed Rule) Federal Register / Volume 71, No. 237 / dated…Monday, December 11, 2006 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.

  8. SDTM Terminology Projects • 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

  9. Core Working Principles • Evaluate and/or utilize existing terminology 1st • 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. 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. Global Pharma & CROs FDA & Academia Controlled Terminology “Nexus” International SDOs Vocabulary Developers Health Level Seven (RCRIM TC)

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

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

  14. Terminology Priorities (2007-early 2008) • Finalize production release of Labtest, SDTM Package 2A and SDTM Package 2Bterminology 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. CV & TB Project Update (Brian McCourt, Anita Walden)

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