HL7 RCRIM Meeting: 9 January 2007

1. CDISC-RCRIM Vocab Update: Related CDISC Terminology Projects HL7 RCRIM Meeting: 9 January 2007 Bron Kisler, CDISC Terminology Program Director bkisler@cdisc.org

2. Outline • Status Update on CDISC Terminology Projects (Bron) • Joint CDISC Terminology / RCRIM Vocabulary Meetings (Bron & Margaret) • EVS Overview / FDA-EVS Terminology Work (Margaret) • Other Vocabulary topics (Patient Safety, Clinical Genomics, etc.)

3. 2006 Snapshot • Completed 1st production release of CDISC Terminology – SDTM Package-1 • Refined collaboration processes for terminology development & production with NCI EVS • Learned and thoroughly tested the NCI terminology environments – NCI Thesaurus and caDSR • Conducted 1st Terminology Training Workshop in collaboration with NCI EVS and NCICB • Launched new terminology projects: SDTM Labtest and SDTM Package-2 (now 2A & 2B)

4. CDISC Terminology Projects

5. CDISC Terminology • Developing controlled terminology for the SDTM distributed across four project teams • SDTM Package-1 Project: 30 code lists and more than 700 controlled terms in production • Labtest Project: 2 code lists with 90 controlled terms • SDTM Package-2A Project: 12 code lists for EG domain and 3 Interventions domains; includes large terminology set for Units of Measure • SDTM Package-2B Project: 15 code lists for PE, VS, SC and AE domains; to include large terminology set for Location (LOC variables)

6. SDTM Package-1 (N=30) • Action Taken with Study Treatment • Age Span • Age Units • Category for Inclusion/Exclusion • Country • Dictionary Name • Diagnosis Group • Domain Abbreviation • Dose Form • Ethnicity • No / Yes/ Unknown Answers • Not Done or Null Answer • Outcome of Event • Reason for Non-Completion • Relation to Reference Period • Route of Administration • AE Severity • Sex • Sex of Participants • Size • Toxicity Grade • System Organ Class • Trial Blinding Schema • Trial Indication Type • Trial Phase • Trial Summary Parameter • Type of Control • Type of Trial • Units for Vital Signs Results • Vital Signs Test Name

7. SDTM Package-1 Project • August: Package-1 Terminology finalized and final concepts created in NCI EVS (NCIt) • September: Moved to NCI public servers in “Pre-Release” status • October: FINAL production terminology formally released in EVS environment • To Do: Move Package-1 from “Draft New” to “Released” status in caDSR; Finalize User Workflow Documents; Education & Training; Change Control / Support & Maintenance NCIt = NCI Thesaurus caDSR = Cancer Data Standards Repository

8. SDTM Labtest Project • Q2 2006: Completed public review of Labtest terms (N=90) • Q3-Q4 2006: Vetted public comments; conducted analysis with existing NCI EVS terms; assigned definitions and finalized CDISC Labtest work • Q1 2007: Create final concepts in EVS (NCIt) and move to production servers • To Do: Formally release production terminology; Determine link with LOINC tables; Begin development of next set of Labtest terms

9. SDTM Package-2A Interventions Domains EG Domain • EGTESTCD (ECG Test or Examination Short Name) • EGTEST (ECG Test or Examination Name) • EGPOS (ECG Position of Subject) • EGSTRESC (Character Result or Finding in Std Format) • EGSTRESU (Standard Units) • EGMETHOD (Method of ECG Test) • CMDOSFRQ (Dosing Frequency per Interval) • CMDOSU (Dose Units) • EXDOSFRQ (Dosing Frequency per Interval) • EXDOSU (Dose Units) • SUDOSFRQ (Use Frequency per Interval) • SUDOSU (Consumption Units) EG = ECG Test Results CM = Concomitant Medications EX = Exposure SU = Substance Use

10. SDTM Package-2A Project • Q4 2006: Established Package-2A project team; Conducted analysis with NCI EVS terms; Completed terminology set with definitions • Q1 2007: Post for public review in accordance with CDISC Standards Development Process • Q2 2007: Vet public comments and finalize CDISC work on terminology set • Q3 2007: Create final concepts in EVS (NCIt) and move to production servers

11. SDTM Package-2B SC & AE Domains PE Domain VS Domain • PETESTCD (Body System Examined Short Name) • PETEST (Body System Examined) • PECAT (Category of Examination) • PEBODSYS (Body System or Organ Class) • PESTRESU(Standard Units) • PESEV (Severity / Intensity) • PELOC (Location of Physical Exam Finding) • VSPOS (Vital Signs Position of Subject) • VSORRESU(Original Units) • VSSTRESU (Standard Units) • VSLOC (Location of Vital Signs Measurement) • SCTESTCD (Subject Characteristics Short Name) • SCTEST (Subject Characteristics) • AEREL (Causality) / deferred from Package-1 project? • AEPATT (Pattern of Event) • AELOC (Location of the Reaction) PE = Physical Examination VS = Vital Signs SC = Subject Characteristics

12. SDTM Package-2B Project • Q1 2007: Kick-off new Package-2A project team and pull together terminology set with definitions • Q2 2007: Post for public review in accordance with CDISC Standards Development Process • Q3 2007: Vet public comments and finalize CDISC work on terminology set • Q4 2007: Create final concepts in EVS (NCIt) and move to production servers

13. 2007 Priorities • Finalize “Terminology” production release for 3 active projects (Labtest, Package-2A, & 2B) • Kick-off terminology implementation project team • Document detailed process for terminology development and production (CDISC Ops Procedure) • Document process for change control and support & maintenance • Further develop Education and Training Course • Identify what’s left and begin developing final primary SDTM Terminology Package • Other terminology priorities for CDISC, SDTM and RCRIM? BRIDG, Microbiology and Pharmacogenomics

14. Joint Meetings

15. Joint Terminology Meetings September WG Meeting…RCRIM agreed to combining CDISC Terminology & RCRIM Vocabulary team calls • Has improved participation in combined activity with team members from both CDISC & RCRIM • Has promoted RCRIM education and information sharing (e.g. SPL, ICSR) across large CDISC team • Ultimately encourages “dual citizenship” across CDISC & RCRIM and cross fertilization of vocabulary activities • Additional Thoughts?

16. Strategy for 2007 • Continue to increase joint team membership to expand terminology workload, accelerate workflow and improve cross project efficiency • Shift and more evenly distribute work across CDISC terminology projects and RCRIM Vocab • Continue to leverage NCI EVS environment for terminology harmonization • Encourage more cross education and training (CDISC, HL7 and RCRIM) • Continue to run call scheduling through CDISC mechanism…?