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RCRIM Vocab Session Tuesday, Session Q4 15 January 2008

This session provides an update on terminology projects including SDTM, CDASH, SEND, ISO, and changes with NCI EVS organization. It also discusses key harmonization activities and 2008 terminology priorities.

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RCRIM Vocab Session Tuesday, Session Q4 15 January 2008

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  1. RCRIM Vocab SessionTuesday, Session Q415 January 2008

  2. Agenda • 3:30 pm – 4:15 pm (Terminology Update) • SDTM Terminology Projects, including Labtest • Key Harmonization Activities (CDASH, SEND, ISO) • 2008 Terminology Priorities (CDISC, RCRIM) • Changes with NCI EVS Organization • 4:15 – 4:35 pm (CHI-RCRIM Mapping) • 4:35 – 4:55 pm (TB & CV Project Report) • 4:55 – 5:00 pm (Wrap-up)

  3. Terminology Update (SDTM Terminology Projects)

  4. SDTM Terminology…in production • SDTM Package 1: 30 code lists & more than 700 controlled terms distributed broadly across SDTM • Labtest Package 1: single code list with 92 controlled terms (those most commonly used for Analytes) • SDTM Package-2A: 12 code lists & more than 600 controlled terms for ECG, Con Meds, Drug Exposure and Substance Use, including Units of Measure & Frequency • http://www.cdisc.org/standards/terminology/index.html-or-http://www.cancer.gov/cancertopics/terminologyresources/ • Terminology Implementation Project Team to assess – production representation and usability; industry requirements; change requests & governance; implementation considerations; ongoing maintenance & version releases (aligned with MedDRA)

  5. SDTM Terminology…in development • Labtest Package 2/3: • SDTM – 200+ additional terms developed and available for public review this month (Labtest Package 2) • SDTM/SEND – 100 terms in development for Vitamins, Enzymes, Immunology, Common drugs from drug screen (Labtest Package 3) • Discussions planned with LOINC • SDTM Package-2B: • 17 code lists & 500+ controlled terms for AE, Physical Exam, Vital Signs and Subject Chars, including Anatomical Location (LOC) • Scope parameters for LOC to constrain initial terminology set; both NCIt and SNOMED considered…both well-representative of needs • Deferred items for Subject Characteristics • New SDTM projects to be launched within 30-days per terminology gap analysis of SDTM IG Ver 3.1.1 (Trial Design, Questionnaires, complete Location)

  6. Terminology Update (Key Harmonization Activities)

  7. Harmonization Activities • General: CDISC INTRAchange Meeting Feb. 5-7 • CDISC Glossary: represented in EVS terminology environment along with SDTM terminology • CDASH (CDISC): aligning SDTM terminology projects with CDASH requirements / timelines with full harmonization planned for Q2 2008 • SEND (CDISC): initial gap analysis with SDTM completed; joint development activities underway • BRIDG (RCRIM): harmonization activities underway via RCRIM TC stakeholders • ISO: Global harmonization via ISO TC215 WG6

  8. CDASH Collaborative Initiative(FDA Critical Path Opportunity) CDASH = Clinical Data Acquisition Standards Harmonization Project Charter • To develop a set of ‘content standards’ (element name, definition, metadata) for a basic set of global industry-wide data collection fields that will support clinical research. The initial scope will be the ‘safety data/domains’. • These safety domains cut across all therapeutic areas, beginning with approximately 12-14 domains (aligned with SDTM)

  9. CDASH Collaborative Initiative • CDASH Package 1: Adverse Events, Concomitant Meds, Demographics, Subject Characteristics • CDASH Package 2: Incl/Excl Criteria, Medical Hx, Substance Use, Physical Exam & Vital Signs • CDASH Package 3: Drug Accountability & Exposure, Comment & Deviations, Disposition / End of Study • CDASH Package 4: Lab & ECG

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

  11. SEND (Standards for Exchange of Non-clinical Data) • May 2007: SEND activities re-energized with f2f meeting • 4 active sub-teams with leadership from Lilly, Merck, Pfizer • Re-baseline • Controlled Terminology • Safety Pharm • Repro • October 2007: Announcement of SEND FDA regulatory pilot per Federal Register Notice • December 2007: Joint f2f meeting with CDISC Terminology and NCI EVS to assess SEND Terminology needs and align with SDTM Terminology timelines • March 2008: FDA SEND pilot scheduled to begin

  12. SEND-SDTM Terminology • Alignment with CDISC / NCI EVS terminology priorities to ensure draft terminology for pilot • Per detailed SEND-SDTM Terminology gap analysis, SDTM terminology accepted for Units of Measure, Dose Form & Routes of Administration • Regarding Labtest & Location, SDTM and SEND Terminology Teams aligned for co-development • Controlled terminology value sets to be developed for Organ Name & Species/Strain

  13. ISO TC215 WG6 • Background: initial proposal to ISO per ICH M5 EWG; standards organizations represented (ICH, CEN, HL7) and CDISC now via ISO Liaison A status • Initial Focus: Scope & Requirements; Controlled Vocabulary; Data Elements; Maintenance Organization • Areas of Consideration (identification of Medicinal Products): • Structures & controlled vocabularies for Ingredients • Structures & controlled vocabularies for Pharmaceutical Product Identifier • Structures & controlled vocabularies for Pharmaceutical Dose Forms, Routes of Administration, Units of Presentation • Data elements & structures for the exchange of regulated product info • Structures & controlled vocabularies for Units of Measure (CDISC contributing) • Pharmacovigilence – Controlled vocabulary for Laboratory Test Units for the reporting of laboratory test results (CDISC contributing)

  14. Terminology Update (2008 Terminology Priorities)

  15. 2008 Terminology Priorities • Finalize terminology needed for SDTM IG Ver 3.1.1 and support / harmonize with other priority CDISC projects – CDASH, SEND, BRIDG, etc… • Support and prioritize HL7 RCRIM-specific projects • BRIDG • CDISC-HL7 Message Project • Labtest Abnormality Assessment • eDCI and other…? • Harmonize with and support new global terminology projects such as those initiated by ISO • Ensure long-term solution for terminology maintenance

  16. Terminology Update (Changes in EVS Organization)

  17. NCI EVS Terminology Support • Formalized CDISC-EVS and FDA-EVS terminology partnership in 2005 with focus on terminology development, publication and long-term maintenance • Committed expertise and dedicated resources for CDISC, FDA and RCRIM-specific Vocabulary projects • Co-developed terminology for SDTM (Package 1, Labtest, SDTM Package 2A/2B); Co-developed terminology for FDA (SPL, ICSR, RPS)

  18. Global Pharma & CROs FDA & Academia Controlled Terminology “Nexus” International SDOs Vocabulary Developers HL7 RCRIM TC

  19. Recent Changes with NCI EVS • EVS organization recently moved under CBIIT / caBIG • Margaret Haber now on assignment with NLM / Betsy Humphreys • Need to identify new NCI EVS Terminology point of contact for CDISC and RCRIM • Future resource commitments in support of RCRIM, CDISC and FDA Terminology activities unclear • Discussion…

  20. CHI-RCRIM Mapping (Ted Klein, HL7 Vocabulary)

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

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