1. CDISC Controlled Terminology Initiative: An Overview
1 June 2007
Bron W. Kisler
CDISC Co-Founder
Terminology Program Director

2. CDISC Terminology Initiative
Overview
Terminology for SDTM
NCI EVS Partnership
The Home Stretch…

3. CDISC Terminology Formalized CDISC Terminology Initiative in 2005
Primary Objective: to define and support the terminology needs of the CDISC models across the clinical trial continuum (SDTM ↔ CDASH)
Terminology Initiative is comprised of 50+ team members (Global Sponsors, Regulatory, Academic Institutions, etc.) distributed across 4 project teams
Key partnership with the US National Cancer Institute Enterprise Vocabulary Services (NCI EVS)
Combined RCRIM Vocabulary & CDISC Terminology teams to ensure common development
SDTM = Study Data Tabulation Model (eSubmissions)
CDASH = Clinical Data Acquisition Standards Harmonization

4. CDISC Technical Roadmap
2005
2006 A B C D
BRIDG (Biomedical Research Integrated Domain Group)
LAB
ODM
SDTM
The
CDISC
Standard
LAB &
DEFINE.XML
LAB,
SDTM,
ODM &
ADaM
PROTOCOL
ODM,
& ADaM
CDISC harmonization milestones
Controlled Terminology

5. The mission of CDISC is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare

6. Ability of two or more systems
Interoperability:
Ability of two or more systems
or components to:
Exchange information (Syntactic Interoperability) and…
Predictably use the information that has been exchanged (Semantic Interoperability)
Source: IEEE Standard Computer Dictionary

7. Semantic Interoperability?
Emitter
SHELL…
silent movie
Receiver
…shall we go now ?

8. Semantic Interoperability
Emitter
Definition
Concept
Term
Receiver

9. Terminology for SDTM

10. SDTM…Syntactic Interoperability
Interventions
Findings
Events
Exposure
Labs
InclExcl AE
ConMeds
Vitals
SubjChar
Disp.
PhysExam
ECG
Subst Use
MedHist QS PG MB

11. SDTM Terminology Projects
SDTM Package-1: 30 code lists & more than 700 controlled terms - in Production
Labtest: single code list with 92 controlled terms –
in Production; 200 additional Analyte terms in development
SDTM Package-2A: 12 code lists & more than 600 controlled terms for EG & Interventions domains (CM, EX, SU) including Units of Measure – Public Review
SDTM Package-2B: 17 code lists & likely controlled terms for AE, PE, VS and SC domains including Anatomical Location – in Development
SDTM = Study Data Tabulation Model

12. SDTM Package-1 (N=30) Action Taken with Study Treatment Age Units
Country
Domain Abbreviation
Ethnicity
Dose Form
Identification variable
Category for Inclusion/Exclusion
Not Done or Null Answer
No / Yes/ Unknown Answers
Outcome of Event
Race (…deferred)
Reason for Non-Completion
Causality
Route of Administration
Severity / Intensity
Sex
Size Code
System Organ Class
Relation to Reference Period
Age Group
Type of Control
Description of Trial Design
Diagnosis Group
Trial Indication Type
Trial Blinding Schema
Standard Toxicity Grade
Trial Phase
Trial Summary Parameter 
Type of Trial
Vital Signs Test Name
Units for Vital Signs

13. SDTM Packages 2A & 2B Interventions Findings Events Exposure Labs
InclExcl AE
ConMeds
Vitals
SubjChar
Disp.
Subst Use
PhysExam
ECG
MedHist QS PG MB

14. Federal Register / Volume 71, No. 237 / Monday, December 11, 2006
Proposed Rule
The Food and Drug Administration is
proposing to amend the regulations
governing the format in which clinical
study data and bioequivalence data are
required to be submitted for new drug
applications (NDAs), biological license
applications (BLAs), and abbreviated
new drug applications (ANDAs). The
proposal would revise our regulations
to require that data submitted for
NDAs, BLAs, and ANDAs, and their
supplements and amendments be
provided in an electronic format that
FDA can process, review, and archive.
The proposal would also require the
use of standardized data structure,
terminology, and code sets contained in
current FDA guidance (the Study Data
Tabulation Model (SDTM) developed
by the Clinical Data Interchange
Standards Consortium) to allow for
more efficient and comprehensive data
review.

15. NCI EVS Partnership

16. Working Principals Evaluate and/or utilize existing terminology 1st
Expand existing vocabularies where incomplete, working with vocabulary developer / owner
Harmonize across CDISC Models and with pre-existing vocabulary initiatives
Ensure terminology recommendations suit international needs for global organizations and projects
Ensure a sustainable “open source” environment for production terminology supporting terminology evolution

17. The Solution…NCI EVS
NCI Enterprise Vocabulary Services (EVS) has committed expertise and significant resources in support of the CDISC Terminology Initiative and FDA Vocabulary Initiatives such as: SPL, ICSR, RPS, CDRH Healthcare Devices, etc…
CDRH = US Center for Devices & Radiological Health
SPL = Structured Product Label
RPS = Regulated Product Submission

18. Once upon a time…

19. CDISC-NCI EVS Partnership
Production
Representations
CDISC CT
NCI EVS
Definition developed
Concept assigned
Harmonized with related work (FDA)
Mapped to other CT
CDISC Codelists in Excel
(Terms only)
**EVS Report Writer
(via .ftp website)
CDISC/FDA Subset files, posted monthly
EVS Term. Browser
caDSR CDE Browser

20. Terminology Development…today (fully integrated processes)
Stage I: Standard Definition/Team Initiation
Stage II (a-e): Standards Development/Review/V 1.0 Release
Initial terminology, code list and definition development (Excel)
Analyze, compare and harmonize with existing EVS terms (NCI Thesaurus)
Standards Review (CDISC Internal & Public Review) / Vet Comments
Finalize terminology set and load into EVS (NCI Thesaurus)
Put terminology in production via .ftp site and NCI Terminology Browser
Assess need for other representations such as caDSR (SDTM P-1)
Stage III: Education & Support
Stage IV: Updates & Maintenance

21. “Standard” Controlled Terminology
Global Pharma & CROs
FDA & Academia
Technology Partners
Global Industry Partners
Health Level Seven
(RCRIM TC)

22. The Home Stretch

23. Liaison Status to ISO/TAG215
Submitted CDISC Standard
as New Work Item
ISO Terminology Task Force
WHO International Clinical
Trial Registry Platform
Terminology Harmonization
Terminology Development
Terminology Publication
Submission Standards
Protocol Representation
Critical Path Initiative –
data collection standards
(CDASH)
Protocol Representation w/
elements mapped to EudraCT
Discussing all CDISC projects
RCRIM Tech Committee
BRIDG Model

24. 2007 Terminology Priorities
Finalize production release of Labtest, SDTM Package 2A and SDTM Package 2B term sets
Harmonize with and support new global terminology projects such as those initiated by ISO, ICH & WHO
Develop user guidelines for production terminology access, download and implementation
Support priority projects such as developing global therapeutic data standards for Tuberculosis & Cardiology
Scope and support important future projects – CDASH, BRIDG, SEND and beyond
Further develop terminology education and training, including workshops and online tutorials
CDASH = Clinical Data Acquisition Standards Harmonization
BRIDG = Biomedical Research Integrated Domain Group

25. Strategy Moving Forward
Continue to increase team membership (65+ in 2007) with broader international coverage
Further refine terminology development / production processes for faster release cycles
Be deliberate in developing new leaders with focus on CDISC Terminology Organization
Expand and improve cross team communication (Glossary Group, new SDS initiatives, CDASH)
Improve cross-fertilization with HL7 RCRIM projects and encourage “dual citizenship”
RCRIM = Regulated Clinical Research Information Management
CDASH = Clinical Data Acquisition Standards Harmonization

26. CDISC is now in “Control” of its terminology
Special Thanks to…
Andreas Gromen (Schering AG, Germany)
Margaret Haber (NCI EVS)
Mary Lenzen (Octagon Research)
CDISC Terminology Team Volunteers
CDISC is now in “Control” of its terminology

27. (Susan Kenny’s slide – may use as a transition back to, “What is CDISC”?)