hl7 rcrim meeting: 9 january 2007 cdisc-rcrim vocab update: related cdisc terminology projects bron...
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![Page 1: HL7 RCRIM Meeting: 9 January 2007 CDISC-RCRIM Vocab Update: Related CDISC Terminology Projects Bron Kisler, CDISC Terminology Program Director bkisler@cdisc.org](https://reader036.vdocuments.us/reader036/viewer/2022082818/56649e985503460f94b9b628/html5/thumbnails/1.jpg)
HL7 RCRIM Meeting:9 January 2007
CDISC-RCRIM Vocab Update:Related CDISC Terminology Projects
Bron Kisler,CDISC Terminology Program [email protected]
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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.)
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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)
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CDISC Terminology Projects
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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)
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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
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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
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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
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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
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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
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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
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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
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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
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Joint Meetings
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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?
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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…?