Transcript CDISC Controlled Terminology Initiative: An Overview 1 June 2007 Bron W. Kisler CDISC Co-Founder Terminology Program Director [email protected].

CDISC Controlled Terminology
Initiative: An Overview
1 June 2007
Bron W. Kisler
CDISC Co-Founder
Terminology Program Director
[email protected]
CDISC Terminology Initiative
 Overview
 Terminology for SDTM
 NCI EVS Partnership
 The Home Stretch…
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
CDISC Technical Roadmap
CDISC harmonization milestones
BRIDG (Biomedical Research Integrated Domain Group)
A
LAB
B
C
SDTM
LAB &
SDTM
ODM
ODM
DEFINE.XML
DEFINE.XML
ADaM
ADaM
ADaM
PROTOCOL
PROTOCOL
PROTOCOL
LAB,
SDTM,
ODM &
DEFINE.XML
D
LAB,
SDTM,
ODM,
DEFINE.XML
& ADaM
PROTOCOL
Controlled Terminology
2005
2005-2006
2006
2006-2010
The
CDISC
Standard
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
Interoperability:
Ability of two or more systems
or components to:
1. Exchange information (Syntactic Interoperability)
and…
2. Predictably use the information that has been
exchanged (Semantic Interoperability)
Source: IEEE Standard Computer Dictionary
Semantic Interoperability
?
SHELL…
Receiver
…shall we go now ?
Emitter
Semantic Interoperability
Definition
Concept
Receiver
Term
Emitter
Terminology for SDTM
SDTM…Syntactic Interoperability
Interventions
Findings
Exposure
Labs
InclExcl
ConMeds
Vitals
SubjChar
Subst Use
PhysExam
ECG
QS
PG
MB
Events
AE
Disp.
MedHist
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 1000+
controlled terms for AE, PE, VS and SC domains
including Anatomical Location – in Development
SDTM = Study Data Tabulation Model
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 NonCompletion
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
SDTM Packages 2A & 2B
Interventions
Findings
Events
Exposure
Labs
InclExcl
AE
ConMeds
Vitals
SubjChar
Disp.
Subst Use
PhysExam
ECG
MedHist
QS
PG
MB
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.
Federal Register / Volume 71,
No. 237 /
Monday, December 11, 2006
NCI EVS Partnership
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 preexisting 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
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
Once upon a time…
CDISC Codelist Specification
CDISC Codelist Values
C ode lis t_ N a m e
SEX
C ode lis t_ N a m e C ontrolle d
Te rm s
C om m e nt
C ode lis t_ La be l
Sex
SEX
U
Unknown
U ppe r_ C a s e
Y
SEX
M
Male
R e s triction_ 8 cha r
N
SEX
F
Female
Exte ns ible _ N Y
N
R e fe re nce _ D e s cription
Organization Name: CDISC
Document Title: Study Data Tabulation
Model
Document Version: 1.0
Date: 2004-06-25
Chapter: Table 2.2.6: Subject
Demographics Domain Variables
Page: 14
Field Name: Description
Ref erence_URL
http://www.cdisc.org/models/sds/v3.
1/index.html
CDISC-NCI EVS Partnership
CDISC CT
CDISC Codelists in Excel
(Terms only)
CDISC Codelist Specification
CDISC Codelist Values
Codelist_Name
Codelist_Name Controlled Terms Comment
SEX
Codelist_Label
Sex
CDISC
Codelist Specification
SEX Codelist UValues
CDISC
Codelist_Name
SEX
Codelist_Name Controlled Terms Comment
Codelist_Label
Sex
SEX
Restriction_8char
Upper_Case
YN
SEX
SEX
M
F
Male
Restriction_8char
Extensible_NY
NN
SEX
SEX
F
UN
Female Undifferentiated
Extensible_NY
N
SEX
Codelist_Name
SEX
Codelist_Name Controlled Terms Comment
Codelist_Label
Sex
SEX
U
Unknown
Upper_Case
Y
SEX
M
Male
Restriction_8char
N
SEX
F
Female
Extensible_NY
N
SEX
UN
Undifferentiated
Reference_Description
Organization Name: CDISC
Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical
Trials
Document Version: 3.1.1
Date: 2005-08-26
Chapter 5.1.1
Page: 36
Field Name: Controlled Terms or Format
Upper_Case
Y
SEX
U
UN
M
Reference_Description Organization Name: CDISC
Organization
Name:Study
CDISCData Tabulation Model Implementation Guide: Human Clinical
Document Title:
Document Title: Study Data Tabulation Model Implementation Guide: Human Clinical
Trials
Trials
DocumentVersion:
Version:
3.1.1
Document
3.1.1
Date:2005-08-26
2005-08-26
Date:
Chapter
Chapter5.1.1
5.1.1
Page: 36
Page: 36
Field Name: Controlled Terms or Format
Reference_URL
Field Name: Controlled Terms or Format
http://www.cdisc.org/models/sdtm/v1.1/index.html
Reference_URL
http://www.cdisc.org/models/sdtm/v1.1/index.html
CDISC Codelist Specification
CDISC Codelist Values
Unknown
NCI EVS
•
•
•
•
Definition developed
Concept assigned
Harmonized with
related work (FDA)
Mapped to other CT
Production
Representations
**EVS Report Writer
(via .ftp website)
CDISC/FDA Subset files,
posted monthly
Male
Unknown
Female
Undifferentiated
EVS Term. Browser
Reference_Description
Reference_URL
http://www.cdisc.org/models/sdtm/v1.1/index.html
caDSR CDE Browser
Terminology Development…today
(fully integrated processes)
Stage I: Standard Definition/Team Initiation
Stage II (a-e): Standards Development/Review/V 1.0 Release
a)
b)
c)
d)
e)
f)
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
“Standard” Controlled Terminology
Global Pharma & CROs
FDA & Academia
Technology Partners
Global Industry Partners
Health Level Seven
(RCRIM TC)
The Home Stretch
• Liaison Status to ISO/TAG215
• Submitted CDISC Standard
as New Work Item
• ISO Terminology Task Force
• Terminology Development
• Terminology Publication
• RCRIM Tech Committee
• BRIDG Model
• WHO International Clinical
Trial Registry Platform
• Terminology Harmonization
• Submission Standards
• Protocol Representation
• Critical Path Initiative –
data collection standards
(CDASH)
• Protocol Representation w/
elements mapped to EudraCT
• Discussing all CDISC projects
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
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
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