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HL7 RCRIM Meeting: 9 January 2007

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CDISC-RCRIM Vocab Update: Related CDISC Terminology Projects. HL7 RCRIM Meeting: 9 January 2007. Bron Kisler, CDISC Terminology Program Director Outline. Status Update on CDISC Terminology Projects (Bron)

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CDISC-RCRIM Vocab Update:

Related CDISC Terminology Projects

HL7 RCRIM Meeting:

9 January 2007

Bron Kisler,

CDISC Terminology Program Director

  • 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.)
2006 snapshot
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)
cdisc terminology
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)
sdtm package 1 n 30
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
sdtm package 1 project
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

sdtm labtest project
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
sdtm package 2a
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

sdtm package 2a project
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
sdtm package 2b
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

sdtm package 2b project
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
2007 priorities
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
joint terminology meetings
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?
strategy for 2007
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…?