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CDISC Controlled Terminology

CDISC Controlled Terminology. HITSP Harm. Subcommittee 1 October 2008 Bron Kisler (CDISC) bkisler@cdisc.org. CDISC Snapshot. Global standards organization initiated in 1997 as a volunteer group; incorporated as non-profit in 2000

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CDISC Controlled Terminology

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  1. CDISC Controlled Terminology HITSP Harm. Subcommittee 1 October 2008 Bron Kisler (CDISC) bkisler@cdisc.org

  2. CDISC Snapshot • Global standards organization initiated in 1997 as a volunteer group; incorporated as non-profit in 2000 • Established worldwide standards to support the electronic acquisition, exchange and submission of clinical research data • 200+ corporate sponsors and member organizations (Global Pharmas, Service Organizations, Technology Vendors, Academic Institutions) • Established Coordinating Committees and annual events in North America, Europe and Japan • Expanding activities in China and India • ISO Liaison A organization

  3. CDISC Mission Clinical Data Interchange Standards Consortium ...to develop and support global, platform-independent datastandards that enable information system interoperability toimprovemedicalresearchand related areas of healthcare

  4. * Specification referenced via FDA Final Guidance

  5. Glossary SDTM / SEND ODM ADaM Protocol LAB Analysis Data CDISC Standards Submissions Data Collection CDASH

  6. Terminology Overview

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

  8. Guiding Principles • Adopt…Adapt…Develop Philosophy • Evaluate and/or utilize existing terminology 1st • Expand existing vocabularies where incomplete, working with vocabulary developer / owner • Harmonize across CDISC standards and with other pre-existing vocabulary initiatives • Address international needs for global projects and organizations • Ensure a sustainable “open source” environment and infrastructure for production terminology supporting terminology evolution

  9. NCI EVS Partnership • Dedicated terminology experts and resources • CDISC controlled terminology development, harmonization, publication and maintenance • Established terminology infrastructure and standard operating procedures • CDISC work space in NCI Thesaurus where terms are coded

  10. Proposed Rule(key driver) Federal Register / Volume 71, No. 237 /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.

  11. FDA PDUFA IV IT Plan…excerpt “For terminology standards, the FDA partners with the National Cancer Institute Enterprise Vocabulary Services (EVS). The NCI EVS hosts the FDA terminologies and makes them freely available to the public.” • NCI EVS supports FDA vocabulary initiatives • Structured Product Label (SPL) • Regulated Product Submission (RPS) • Individual Case Safety Report (ICSR)

  12. LOINC SNOMED MedDRA MeSH ICD’s . . . 60+ Controlled Vocabularies CDISC-FDA Harmonization http://www.cancer.gov/cancertopics/terminologyresources/ NCI Thesaurus

  13. Interventions Events Findings Conmeds AE ECG Ques’aire Exposure Disposition Incl/Excl SubjChar SubstUse MedHx Labs Vitals Deviations PhysExam DrugAcct Clinical Events PK Conc PK Param Micro MB Micro MS Submissions – SDTM version 3.1.2 Special Purpose Demog Comments RELREC SUPPQUAL SubjElements SubjVisits Trial Design (5 Tables) SDTM = Study Data Tabulation Model

  14. POSITION codelist Example(SDTM & CDASH – VSPOS, EGPOS / HL7) Standard Terminology Codelist • Sitting • Prone • Standing • Supine • Fowlers • Semi-Fowlers • Trendelenburg • Reverse Trendelenburg • Right Lateral Decubitus • Left Lateral Decubitus CDISC Controlled Terminology

  15. Terminology – Production & Development

  16. SDTM Terminology(~2300 production terms) • http://www.cdisc.org/standards/terminology/index.html http://www.cancer.gov/cancertopics/terminologyresources/CDISC • SDTM Package 1: 30 codelists & 825controlled terms distributed broadly across SDTM • Labtest Package 1: single codelist with 180 controlled terms for Laboratory Test Results (commonly used for Analytes) • SDTM Package-2A: 12 codelists & 590 controlled terms for ECG, Con Meds, Drug Exposure and Substance Use, including Units & Frequency • SDTM Package-2B: 7 codelists & 330 controlled terms for Location (LOC), Disposition Event, Race, Subject Chars, Marital Status, Skin Classification and Skin Type • Labtest Package 2: Additional 260 controlled terms for Laboratory Test Results

  17. SDTM & CDASH Terminology(~220 terms available for public review) • See What’s New on CDISC homepage http://www.cdisc.org/ • SDTM Package-3: • 6 code lists & 70 controlled terms developed • Available for public review through Oct. 17 and will be moved into production by year’s end • Drug Accountability Test (DATEST), Evaluator, Reference Range Indicator, Relationship Type, Specimen Type, Specimen Condition • Labtest Package-3: • SDTM – 180 additional terms developed and available for public review through Oct. 17 • Terms aligned between SDTM and SEND • Ongoing consideration to align with LOINC • CDASH-Specific Codelists: • Ongoing/Resolved (MHONG) and Prompt for Substance Use (SUNCF)

  18. What’s Next?

  19. Future Plans • Complete terminology for SDTM IG version 3.1.1 (December 2008) • Formalize terminology maintenance process via NCI EVS mechanism to address additions and change requests • Complete terminology alignment for CDASH version 1.0 (early Spring 2009) • Consider new SDTM domains (Pharmacokinetics, Microbiology)

  20. Future Plans (Cont.) • Support and harmonize terminology with other maturing CDISC standards (ADaM, SEND) • Continue extending harmonization with other standards initiatives (ISO, HL7, CEN, HITSP) • Align terminology with BRIDG model and to support CDISC-HL7 message project(s) • Continue to support disease-specific standards activities (TB, CV)

  21. CDISC operates to advance the continued improvement of public health by enabling efficiencies in medical research and related areas of healthcare. www.cdisc.org Strength through collaboration… As a catalyst for productive collaboration, CDISC brings together individuals spanning the healthcare continuum to develop global, open, consensus-based medical research data standards.

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