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CDISC-RCRIM Vocab Update: Related CDISC Terminology Projects. HL7 RCRIM Meeting: 9 January 2007. Bron Kisler, CDISC Terminology Program Director [email protected] 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

[email protected]


  • 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…?