© 2011
CDISC: Global Approach
To Accelerating Medical Research
© 2011
CDISC Mission
To develop and support global, platformindependent data standards that enable
information system interoperability to
improve medical research and related
areas of healthcare
The CDISC Vision is informing patient
care and safety through higher quality
medical research.
© 2011
CDISC
• Global, open, multi-disciplinary, vendorneutral, non-profit standards developing
organization (SDO)
• Founded 1997, incorporated 2000
• Member-supported (>300 members, e.g.
academia, biopharma, service / technology
providers)
• Liaison A Status with ISO TC 215
• Charter agreement with HL7 (2001)
• Leadership of Joint Initiative Council (JIC)
for Global Harmonization of Standards
• Member of ANSI-led ISO TAG
• Active Coordinating Committees (3C)

Europe, Japan, China, Korea
• >> 90 countries in participant database
© 2011
• CDISC has established worldwide industry
standards to support the electronic
acquisition, exchange, submission and
archiving of clinical research data and
metadata to improve data quality and streamline
medical and biopharmaceutical product
development and research processes
• Consensus-based development (COP-001)
• Standards are freely available at www.cdisc.org
• IP Policy ensures open standards
© 2011
CDISC Organization
• Volunteer participants and team members
 CDISC Teams: Anyone can participate
 3Cs (CDISC Coordinating Committees)
 User Networks (regional, often language-centered)
• Technical Leadership Committee
 Team leaders / co-leads
 Oversees the standards development and project teams
 Works to achieve operational and strategic goals
© 2011
Healthcare
Information from healthcare
(private, aggregated)
to enable research
•Quality healthcare
•Informed decisions
•Personalized medicine
•Patient safety and privacy
•Public health
•Improved therapies
•Efficiencies/reduced costs
Inefficient
cycle
Research findings
to inform
healthcare
decisions
© 2011
Research
•Discovery of new therapies
•Understanding diseases
•Testing/comparing therapies
(CER)
•Assessing efficacy
•Monitoring safety
•Understanding responses
(genomics, biomarkers)
•Public health/quality
evaluations
•Post-marketing surveillance
Organization to Support CDISC
User Networks
Technical Projects
Education and Implementation
Services
Alliances
CCC
PR/Communications
CAB
8
© 2011
Project
Teams
T
L
C
Financial; Legal; HR
Board
TAC
Strategy
Gov
FOC
Board
Committees:
Global Operations
CDISC Standards Development Process (COP-001)
Stage I: Standard Definition/Team Initiation
Need for
Specific
Standard(s)
Identified
(any stakeholder)
Proposal
to Board
of Directors
(via Operations)
Review per
strategy, budget
priorities
Approve
d
Team Leader ID
And Team
Formation
(multidisciplinary)
(Operations)
Working Plan
(timelines, deliverables
communication mech.,
resources req’d)
(Team )
Not
Approved
Stage II: Standards Development/Review/V 1.0 Release
Testing
Consensus
(Initial)
Version
TLC
Review
Harmonized
Version
Comments addressed
External
Focused
Review
Review
Version
Released
(Production)
Public
Review
Version
1.0
Comments to address by
team
Stage III: Education & Support
Respond
To Comments
And Questions
Educational
Programs
(EDU, Operations)
Stage IV: Standards Update & Maintenance
Annual Review of
Released Version
(comments, chg
reqsts, tests, plans)
(Team)
Working Plan
(timelines, deliverables,
communication mech.,
resources req’d)
(Team)
© 2011
Consensus
(Revised)
Version
TLC
Review
Optional
Ex
Focused
Review
Harmonized
Version
Public
Review
as
needed
Note: Occasional bug fix releases may be
issued as needed with team review only.
New
Released
(Production)
Version
9
Joint Initiative Council
Current leader: Bron Kisler, CDISC
For the global
harmonization of
healthcare and
related standards.
BRIDG is going through the JIC Process; it is now an
HL7 and CDISC standard – one ballot left in ISO (and CEN).
© 2011
General Standards Organizations
• ISO (cont.)
– CDISC is a Liaison A status to ISO TC 215 (healthcare
standards)
• Possible because CDISC process conforms to ISO
standards
• Allows CDISC to skip some initial steps in ISO
approval
• Means CDISC standards can be approved as ISO
standards
• ANSI
– American National Standards Institute, US representative to ISO
– CDISC standards developed with HL-7 can be ANSI-accredited
– CEN
– European equivalent of ANSI
© 2011
CDISC Around the Globe
2010
2001
2000
© 2011
2008
2002
12
Business Case
For Using CDISC Standards
© 2011
Gartner-PhRMA-CDISC Project
• Business Case for using CDISC standards
• Summary:
 Using CDISC standards can save significant time and
cost, especially when implemented in the early stages of
the study
 Opportunities for an additional impact on clinical
research
• Increased data quality
• Data Integration / enhanced re-usability
• Facilitates data exchange with partners
• Enable software tools
• Improve team communication
• Facilitate regulatory reviews and audits
Opportunity Value: Do More With Less
© 2011
Study Start-up
Study Conduct
Analysis /
Reporting
Submission
40%
Patient recruitment
Site/PI Identification
Site evaluation
Site initiation
Patient recruitment plan
Critical documents
IRB approvals
80%
40%
50%
5 Months
Patient
Participation
+ 4 Months
5 Months
© 2011
12 Months
CDISC Standards and Data Flow
© 2011
CDISC Standards
• Glossary
• SDTM - Study Data Tabulation Model
• CDASH - Clinical Data Acquisition Standards
Harmonization
• ADaM - Analysis Data Model
• LAB - Laboratory
• Terminology
• TDM - Trial Design Model
• Protocol Representation
© 2011
CDISC Standards
• Therapeutic Area Standards
• BRIDG - Biomedical Research Integrated Domain
Group Model
• SHARE – Shared Health and Clinical Research
Electronic Library
• ODM - Operational Data Model
• RFD – Retrieve Form for Data Capture
• define.XML
• SEND - Standard for the Exchange of Non-clinical
Data
© 2011
www.cdisc.org
CDISC Standards – Open and Free
© 2011
Glossary
© 2011
20
SME View
Canonical View
OWL View HL7 RIM View
© 2011
CDISC is More than Standards!
CDISC Vision
Informing patient care and safety through higher quality
medical research
© 2011
Backup
© 2011
CDISC Standards
• SDTM - Study Data Tabulation Model
• CDASH - Clinical Data Acquisition Standards
Harmonization
• ADaM - Analysis Data Model
• LAB - Laboratory
• Medical Devices
• Terminology
• TDM - Trial Design Model
• Protocol Representation
© 2011
CDISC Standards
• Therapeutic Area Standards
• BRIDG - Biomedical Research Integrated Domain Group
Model
• SHARE – Shared Health and Clinical Research Electronic
Library
• ODM - Operational Data Model
• RFD – Retrieve Form for Data Capture
• define.XML
• SEND - Standard for the Exchange of Non-clinical Data
© 2011
SDTM
• Study Data Tabulation Model
• Structure and content of clinical data in electronic
regulatory submissions files
• Managed by the SDS team (Submission Data Standards)
• The model is in Version 1.2
• SDTM Implementation Guide (IG) is Version 3.1.2
• FDA now accepts Version 3.1.1 and 3.1.2
• Always check with reviewer before sending
© 2011
SDTM IG
• Provides information on
 Variable and domain naming conventions
 Dataset definitions for 21 subject data-related domains
and several study description domains
 How to create data relationships
 How to develop new domains
 How to think about and understand clinical data dataset
structures
© 2011
CDASH
• Clinical Data Acquisition Standards Harmonization,
Version 1.0
• ‘Content standards’ for a basic set of global industry-wide
data collection fields to support clinical research
• Not CRF layouts
• System-independent, open source, free
• Initial scope: 16 core safety domains
• Covers both paper and electronic data capture
© 2011
CDASH Content: Core Domains
•
•
•
•
•
•
•
•
•
Common Identifier Variables
Common Timing Variables
Adverse Events (AE)
Concomitant Medications
(CM)
Comments (CO)
Drug Accountability (DA)
Demographics (DM)
Disposition (DS)
Protocol Deviations (DV)
© 2011
•
•
•
•
•
•
•
•
•
ECG (EG)
Exposure (EX)
Inclusion Exclusion (IE)
Lab Test Results (LB)
Medical History (MH)
Physical Exam (PE)
Vital Signs (VS)
Subject Characteristics (SC)
Substance Use (SU)
29
CDASH Content
• Data design best practices, e.g.,
 Use of yes/no questions
 Date format
• Recommended methodologies for creating data
collection instruments
• Common controlled terminology
• Regulatory references for each domain
© 2011
30
CDASH User Guide v1.0
• In development, expected publication 1Q10
• Will contain







General assumptions about each domain
Implementation examples
ODM XML structure for data transmission
Electronically-generated CRF examples
Variables not included in the standard
CDASH to SDTM mapping
Horizontal vs vertical data structures
© 2011
31
ADaM
•
•
•
•
Analysis Data Model
Structure of analysis datasets for submission
Some limited information on specific fields expected
Planning to release a User Guide with more guidance on
implementing the model
© 2011
LAB
• Provides specifications for electronic transfer of central lab
data
• Extensions for microbiology and ECG data
• A subset of the most commonly used LOINC terms
© 2011
Medical Devices
• Currently in development
• Will provide device-specific domains




Device properties
Device tracking
Device disposition
Device malfunctions
• First stage addresses implantable devices and other
similar devices
• Later will include imaging and diagnostics
© 2011
Terminology
• Set of controlled terms used in CDISC standards
• Provides the answers to the questions asked by the
fields/variables
• Maintained by NCI Electronic Vocabulary Services (EVS)
© 2011
TDM
• Trial/Study Design Model
• Electronic representation of the schedule of activities
(planned assessments, interventions, administrative
activities, and encounters)
• It’s the study schedule in searchable structured electronic
format
© 2011
Protocol
• Defines trial elements electronically
• Allows the protocol to be described electronically and the
elements search and reused
• Includes eligibility criteria, trial design elements (e.g.,
Arms, epochs), trial schedule of events, and selected
fields required by regulatory authorities (e.g., date of first
subject enrolled, sponsor name)
© 2011
Therapeutic Area Standards
• Draft standards are available for
 Cardiovascular: Acute Coronary Syndrome
 Pulmonary Tuberculosis
• A draft standard is being produced for basic oncology
tumor measurements
© 2011
BRIDG
• Biomedical Research Integrated Domain Group Model
• Framework for linking and harmonizing the other
standards
• Defines each field as a concept with an agreed meaning
and set of characteristics
• Foundation for linking CDISC to EHR and other data
sources
© 2011
SHARE
• Shared Health and Clinical Research Electronic Library
• A standards authoring tool that
 Facilitates gathering and comparing existing material to distill a
preferred approach
 Provides a repository for standard data elements
 Permits some associations between elements
• This is in development and has completed its first pilot
© 2011
ODM
• Operational Data Model
• An XML definition for transmitting CDISC data between
systems
• Currently primarily on data exchange between labs and
sponsors, and the like
• Extension being developed to support data exchange for
CDASH data, and data exchange of CDASH data with
eHR applications
© 2011
RFD
• Retrieve Form for Data Capture
• Broadly, it is “a method for gathering data within a
user’s current application to meet the
requirements of an external system.” (IHE Wiki)
• “RFD supports the retrieval of forms from a form
source, display and completion of a form, and
return of instance data from the display
application to the source application” (IHE Wiki)
• CDISC: applied to the interface between eHR and
Electronic Data Capture (EDC) systems
• In development
© 2011
define.XML
• The metadata sent to the FDA describing the SDTM
datasets in the regulatory submission
• Based primarily on the first 5 columns of the SDTM IG
• Written in XML
© 2011
SEND
• Standard for the Exchange of Non-clinical Data
• SEND IG: An implementation of SDTM for animal
toxicology data
• Currently in Phase II pilot with the FDA
© 2011
How It All Fits Together
BRIDG
Vendors
SHARE
ADaM
Protocol
Representatio
n
Trial Design
Model
Controlled
Terminolog
y
CDASH
SDTM IG
FDA
LAB
Devices
SEND
ODM
© 2011
define.xml
45