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

2. Outline 1.Status Update on CDISC Terminology Projects (Bron) 2.Joint CDISC Terminology / RCRIM Vocabulary Meetings (Bron & Margaret) 3.EVS Overview / FDA-EVS Terminology Work (Margaret) 4.Other Vocabulary topics (Patient Safety, Clinical Genomics, etc.)

3. 2006 Snapshot Completed 1 st 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 ThesauruscaDSR = 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 CMDOSFRQ (Dosing Frequency per Interval) CMDOSU (Dose Units) EXDOSFRQ (Dosing Frequency per Interval) EXDOSU (Dose Units) SUDOSFRQ (Use Frequency per Interval) SUDOSU (Consumption Units) 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) EG Domain Interventions Domains 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 PE DomainVS Domain PE = Physical Examination 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) VS = Vital SignsSC = Subject Characteristics SC & AE Domains

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…?