1. CDISC Controlled Terminology
HITSP Harm. Subcommittee
1 October 2008
Bron Kisler (CDISC)

2. CDISC Snapshot
Global standards organization initiated in 1997 as a volunteer group; incorporated as non-profit in 2000
Established worldwide standards to support the electronic acquisition, exchange and submission of clinical research data
200+ corporate sponsors and member organizations (Global Pharmas, Service Organizations, Technology Vendors, Academic Institutions)
Established Coordinating Committees and annual events in North America, Europe and Japan
Expanding activities in China and India
ISO Liaison A organization
Controlled Terminology represents one of CDISC’s broadest and most ambitious initiatives.
We formalized…
Primary Objective…across the clinical trial continuum from the point of data collection through to eSubmissions

3. CDISC Mission
Clinical Data Interchange Standards Consortium
...to develop and support global, platform-independent data standards that enable information system interoperability
to improve medical research and related areas of healthcare
Controlled Terminology represents one of CDISC’s broadest and most ambitious initiatives.
We formalized…
Primary Objective…across the clinical trial continuum from the point of data collection through to eSubmissions

4. CDISC Standards Description 2004* 2001* 2005* 2002 2004 Fall 2008
Implementation Version Release Date
SDTM, SEND
(Reg. Submission)
Ready for regulatory submission of CRT
Over 10,000 downloads as of late-2007
2004*
ODM
CDISC Transport Standard for data interchange (acquisition, exchange, documentation and archive)
2001*
Define.xml
Case Report Tabulation Data Definition Specification (submission documentation)
2005*
LAB
Content standard – available for transfer of clinical lab data to sponsors
2002
ADaM
(Analysis Data)
Analysis data for submissions - general considerations document and examples
2004
Protocol
Representation
Collaborative effort to develop machine-readable standard protocol with data layer
Fall 2008
Terminology
Codelists
Developing standard terminology to support all CDISC standards
Pkg-1
Pkg-2
CDASH
(Data Collection)
Data acquisition (CRF) standards
Sept. 2008
* Specification referenced via FDA Final Guidance

5. CDISC Standards Submissions Data Collection Analysis Data Glossary
SDTM / SEND
CDASH
ODM
LAB
ADaM
Analysis Data
Protocol 5

6. 6

7. Terminology Overview

8. Terminology Snapshot
Primary Objective: to define and support the terminology needs of CDISC standards across the clinical trial continuum (SDTM → CDASH)
Focus on “standard” terminology codelist development and publication, beginning with SDTM IG version (safety data domains)
Key partnership with US National Cancer Institute Enterprise Vocabulary Services (NCI EVS) with terms coded in NCI Thesaurus
Key harmonization activities with FDA, ISO, NCI, HL7 RCRIM, etc.
Controlled Terminology represents one of CDISC’s broadest and most ambitious initiatives.
We formalized…
Primary Objective…across the clinical trial continuum from the point of data collection through to eSubmissions

9. Guiding Principles Adopt…Adapt…Develop Philosophy
Evaluate and/or utilize existing terminology 1st
Expand existing vocabularies where incomplete, working with vocabulary developer / owner
Harmonize across CDISC standards and with other pre-existing vocabulary initiatives
Address international needs for global projects and organizations
Ensure a sustainable “open source” environment and infrastructure for production terminology supporting terminology evolution
When we first kicked-off the CDISC Terminology Initiative we identified a set a key working principals (or key objectives) to help guide terminology development. I am pleased to say these guiding principals still hold true today.
The first objective is to “define and support…” The initial scope of work here centered around defining terminology for the SDTM. …
Since we are a standards org, we need to be sure we are consistent and standardized throughout the org and across all the various CDISC teams…The CDISC Technical Roadmap
Finally, we want to “Ensure a harmonized approach…” (NCI, FDA, SDOs) Harmonization is a recurring theme that you will be hearing, because it is a critically important component of standards development. It is the harmonization aspect that will ultimately determine the interoperability and usability of the standards we develop. Standards development in isolation does not work…
In looking for a Terminology partner there was only one organization that met these important criteria.

10. NCI EVS Partnership Dedicated terminology experts and resources
CDISC controlled terminology development, harmonization, publication and maintenance
Established terminology infrastructure and standard operating procedures
CDISC work space in NCI Thesaurus where terms are coded
The Enterprise Vocabulary Services of the National Cancer Institute has committed dedicated resources and is making a significant investment in the CDISC Terminology Program. This is of tremendous value to CDISC, as it allows us to leverage EVS’s rich knowledge / expertise in the area of Terminology Development and Production as well as their mature terminology infrastructure.
Also important to CDISC, is the fact that NCI EVS is supporting key FDA Vocabulary projects in the same manner. This ensures well-aligned synergistic goals that effectively triangulate the partnership(s).

11. Proposed Rule (key driver)
Federal Register / Volume 71, No. 237 / Monday, December 11, 2006
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.

12. FDA PDUFA IV IT Plan…excerpt
“For terminology standards, the FDA partners with the National Cancer Institute Enterprise Vocabulary Services (EVS). The NCI EVS hosts the FDA terminologies and makes them freely available to the public.”
NCI EVS supports FDA vocabulary initiatives
Structured Product Label (SPL)
Regulated Product Submission (RPS)
Individual Case Safety Report (ICSR)

13. CDISC-FDA Harmonization
LOINC
SNOMED
MedDRA
MeSH
ICD’s .
60+
Controlled
Vocabularies
NCI Thesaurus

14. Submissions – SDTM version 3.1.2
Interventions
Exposure
Conmeds
SubstUse
Events AE
Deviations
Disposition
MedHx
Clinical
Findings
Vitals
Labs
ECG
Incl/Excl
SubjChar
Ques’aire
Micro MS
Micro MB
DrugAcct
PhysExam
PK Param
PK Conc
Special
Purpose
Demog
Comments
RELREC
SUPPQUAL
SubjElements
SubjVisits
Trial Design
(5 Tables)
SDTM = Study Data Tabulation Model

15. POSITION codelist Example (SDTM & CDASH – VSPOS, EGPOS / HL7)
Standard Terminology Codelist
Sitting
Prone
Standing
Supine
Fowlers
Semi-Fowlers
Trendelenburg
Reverse Trendelenburg
Right Lateral Decubitus
Left Lateral Decubitus
CDISC
Controlled
Terminology
If each of the 3 companies shared a standardized code list, information can be exchange more seamlessly and semantic interoperability would be possible.
To eliminate any potential confusion, it is important to note that there is actual controlled terminology for both the field name (or code list name) and each permissible value.
**This is a highly debated codelist

16. Terminology – Production & Development

17. SDTM Terminology (~2300 production terms)
SDTM Package 1: 30 codelists & 825 controlled terms distributed broadly across SDTM
Labtest Package 1: single codelist with 180 controlled terms for Laboratory Test Results (commonly used for Analytes)
SDTM Package-2A: 12 codelists & 590 controlled terms for ECG, Con Meds, Drug Exposure and Substance Use, including Units & Frequency
SDTM Package-2B: 7 codelists & 330 controlled terms for Location (LOC), Disposition Event, Race, Subject Chars, Marital Status, Skin Classification and Skin Type
Labtest Package 2: Additional 260 controlled terms for Laboratory Test Results
First the SDTM was evaluated, and we identified specific fields (or variables) that needed Controlled Terminology. Then, project teams were formed around specific terminology sets. A terminology project team is responsible for a terminology set from initial development and through to its production.
These terminology project teams are made up of SDS Team Members and representatives from Pharma/CROs, Academia and Government Agencies and Institutions. We ensure each project team has international representation.
1 – Our 1st project (SDTM Package-1) is now IN PRODUCTION. This basically includes SDTM fields with easier and more well-defined code lists distributed broadly across the SDTM. This project was our training wheels to learn what the development of true Controlled Terminology really meant. One of our lessons learned is it was too broad in scope.
2 – For our 2nd project, we applied a very focused approach developing terminology for a single field (Labtest). This development work has proceeded rapidly.
3 & 4 – Applying the lessons learned from these 1st two projects, we have settled on an approach somewhere in between – SDTM Package 2A and 2B

18. SDTM & CDASH Terminology (~220 terms available for public review)
See What’s New on CDISC homepage
SDTM Package-3:
6 code lists & 70 controlled terms developed
Available for public review through Oct. 17 and will be moved into production by year’s end
Drug Accountability Test (DATEST), Evaluator, Reference Range Indicator, Relationship Type, Specimen Type, Specimen Condition
Labtest Package-3:
SDTM – 180 additional terms developed and available for public review through Oct. 17
Terms aligned between SDTM and SEND
Ongoing consideration to align with LOINC
CDASH-Specific Codelists:
Ongoing/Resolved (MHONG) and Prompt for Substance Use (SUNCF)
First the SDTM was evaluated, and we identified specific fields (or variables) that needed Controlled Terminology. Then, project teams were formed around specific terminology sets. A terminology project team is responsible for a terminology set from initial development and through to its production.
These terminology project teams are made up of SDS Team Members and representatives from Pharma/CROs, Academia and Government Agencies and Institutions. We ensure each project team has international representation.
1 – Our 1st project (SDTM Package-1) is now IN PRODUCTION. This basically includes SDTM fields with easier and more well-defined code lists distributed broadly across the SDTM. This project was our training wheels to learn what the development of true Controlled Terminology really meant. One of our lessons learned is it was too broad in scope.
2 – For our 2nd project, we applied a very focused approach developing terminology for a single field (Labtest). This development work has proceeded rapidly.
3 & 4 – Applying the lessons learned from these 1st two projects, we have settled on an approach somewhere in between – SDTM Package 2A and 2B

19. What’s Next?

20. Future Plans
Complete terminology for SDTM IG version (December 2008)
Formalize terminology maintenance process via NCI EVS mechanism to address additions and change requests
Complete terminology alignment for CDASH version 1.0 (early Spring 2009)
Consider new SDTM domains (Pharmacokinetics, Microbiology)
First the SDTM was evaluated, and we identified specific fields (or variables) that needed Controlled Terminology. Then, project teams were formed around specific terminology sets. A terminology project team is responsible for a terminology set from initial development and through to its production.
These terminology project teams are made up of SDS Team Members and representatives from Pharma/CROs, Academia and Government Agencies and Institutions. We ensure each project team has international representation.
1 – Our 1st project (SDTM Package-1) is now IN PRODUCTION. This basically includes SDTM fields with easier and more well-defined code lists distributed broadly across the SDTM. This project was our training wheels to learn what the development of true Controlled Terminology really meant. One of our lessons learned is it was too broad in scope.
2 – For our 2nd project, we applied a very focused approach developing terminology for a single field (Labtest). This development work has proceeded rapidly.
3 & 4 – Applying the lessons learned from these 1st two projects, we have settled on an approach somewhere in between – SDTM Package 2A and 2B

21. Future Plans (Cont.)
Support and harmonize terminology with other maturing CDISC standards (ADaM, SEND)
Continue extending harmonization with other standards initiatives (ISO, HL7, CEN, HITSP)
Align terminology with BRIDG model and to support CDISC-HL7 message project(s)
Continue to support disease-specific standards activities (TB, CV)
First the SDTM was evaluated, and we identified specific fields (or variables) that needed Controlled Terminology. Then, project teams were formed around specific terminology sets. A terminology project team is responsible for a terminology set from initial development and through to its production.
These terminology project teams are made up of SDS Team Members and representatives from Pharma/CROs, Academia and Government Agencies and Institutions. We ensure each project team has international representation.
1 – Our 1st project (SDTM Package-1) is now IN PRODUCTION. This basically includes SDTM fields with easier and more well-defined code lists distributed broadly across the SDTM. This project was our training wheels to learn what the development of true Controlled Terminology really meant. One of our lessons learned is it was too broad in scope.
2 – For our 2nd project, we applied a very focused approach developing terminology for a single field (Labtest). This development work has proceeded rapidly.
3 & 4 – Applying the lessons learned from these 1st two projects, we have settled on an approach somewhere in between – SDTM Package 2A and 2B

22. Strength through collaboration…
CDISC operates to advance the continued improvement of public health
by enabling efficiencies in medical research and related areas of healthcare.
Strength through collaboration…
First the SDTM was evaluated, and we identified specific fields (or variables) that needed Controlled Terminology. Then, project teams were formed around specific terminology sets. A terminology project team is responsible for a terminology set from initial development and through to its production.
These terminology project teams are made up of SDS Team Members and representatives from Pharma/CROs, Academia and Government Agencies and Institutions. We ensure each project team has international representation.
1 – Our 1st project (SDTM Package-1) is now IN PRODUCTION. This basically includes SDTM fields with easier and more well-defined code lists distributed broadly across the SDTM. This project was our training wheels to learn what the development of true Controlled Terminology really meant. One of our lessons learned is it was too broad in scope.
2 – For our 2nd project, we applied a very focused approach developing terminology for a single field (Labtest). This development work has proceeded rapidly.
3 & 4 – Applying the lessons learned from these 1st two projects, we have settled on an approach somewhere in between – SDTM Package 2A and 2B
As a catalyst for productive collaboration, CDISC brings together
individuals spanning the healthcare continuum to develop
global, open, consensus-based medical research data standards.