HL7 RCRIM Meeting: 9 January 2007

HL7 RCRIM Meeting:9 January 2007

CDISC-RCRIM Vocab Update:Related CDISC Terminology Projects

Bron Kisler,CDISC Terminology Program [email protected]

mailto:[email protected]

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.)

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 Projects

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)

• 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

• 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

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

• 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 = ExposureSU = Substance Use

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


SDTM Package-2BPE Domain VS 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 Signs SC = Subject Characteristics

SC & AE Domains

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


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 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

• 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…?