INTRODUCTION TO CDISC

Introduction  to  CDISC

CDISC  Overview
CDISC  Principles  &  Scope
Why  Standards?
CDISC  Benefits
Introduction  to  CDISC  Models
CDISC  OVERVIEW
What  is  CDISC?
CDISC (Clinical Data Interchange Standard Consortium)

CDISC is an open, multidisciplinary, non-profit

organization committed to the development of industry
standards to support the electronic acquisition,
exchange, submission and archiving of clinical trials
data and metadata for medical and biopharmaceutical
product development.
What  is  CDISC?

The mission of CDISC is to lead the development of

global, vendor-neutral, platform-independent
standards to improve data quality and accelerate
product development in our industry.
CDISC  :  History
-­‐ Formed  in  1997  as  a  volunteer  group    
-­‐ As  of  2000,  funded  as  non-­‐profit  organization
-­‐ Now  supported  by    >140  corporate  members:  pharmaceutical
companies;  biotech  companies;  CROs;  technology  providers
-­‐ CDISC  Groups  now  growing  in  Japan,  Europe;  initiated  in  India
-­‐ Standards  developed  through  consensus-­‐based  approach  by  
teams  of  volunteers;  public  reviews
-­‐ No  fee  for  use  of  the  standards;  freely  available  on  CDISC  
website  (www.cdisc.org)
CDISC  PRINCIPLES &  SCOPE
CDISC  Principles
-­‐ Develop  standard  data  models  that  support  the  scientific  
nature  of  clinical  research
-­‐ Flexible,  easily  interpreted  regulatory  submissions
-­‐ Model  quality  and  integrity,  independent  of  implementation  
strategy  and  platform
-­‐ Global,  multidisciplinary,  cross-­‐functional  teams
-­‐ Maximum  sharing  of  information  with  other  groups
-­‐ Educational  programs  
-­‐ Not  promote  any  individual  vendor  or  organization
CDISC  Scope

Standardization  and  exchangeability

WHY STANDARDS?
Problems  faced  by  Industry…
-­‐ Most  of  the  clinical  trials  are  multi-­‐centric  spread  across  several  
countries

-­‐ The  volumes  of  clinical  data  generated  by  clinical  trials  are  high

-­‐ Most  of  the  companies  still  use  proprietary  standards  

-­‐ Data  interchange  between  CRO’s/Hospitals/Labs/Sponsors  have  

become  complex

-­‐ CRO’s  find  it  difficult  to  change  the  standards  as  per  sponsor  
specifications  for  every  trial.
Problems  faced  by  Industry
-­‐ Using  specialized  vendor  specific  software  for  converting  the  
data  from  one  format  to  another  has  pushed  the  operational    
costs

-­‐ Maintenance  of  specialized  vendor  specific  software  with  

proprietary  standards  is  difficult

-­‐ Legacy  system  integration  is  difficult  and  time  consuming

-­‐ Consolidating  the  data  for  regulatory  submissions  from  

different  sources  takes  a  lot  of  time  and  money
The  Move  to  standards
§ “Faced  with  rapid  changes,  the  nation’s   healthcare  system  has  fallen  short  of  its  
ability  to  translate  information  into  knowledge  that  can  be  used  in  practice,  and  to  
apply  new  technology   safely  and  appropriately.
The  results  are  exactly  what  you  would  expect.  Everyone  who  uses  the  current  system  
constantly  confronts  large  information  gaps,  whether  it’s  at  the  doctor’s   office,  on  
the  hospital  ward  or  at  government   agencies  charged  with  protecting   the  public  
health.  That  goes  for  the  FDA-­‐we’re  no  exception.”-­‐
“Innovation  depends   upon   standardization.”

§ Dr.  Bob  O’Neill,  Director,  Office  of  Biostatistics,  CDER,  FDA

World  WITHOUT  Standards

Central Lab

Case Report Form

Medical Imaging CDMS Submission Analysis

Database(s) Database Database
Diagnostics

IVRS

Data
Safety
Transform CDMS Submission Analysis
Database(s) Database Database
EDC/Web

Diary

Lab Systems
CDMS Submission Analysis
???
Database(s) Database Database

Data Streams /
Databases $$$ $$$ $$$$
World  WITH  Standards

Central Lab

Case Report Form

Medical Imaging

Diagnostics

IVRS
Data Operations Submission
Analysis
Safety Transform Data Data
Database
Warehouse Warehouse
EDC/Web

Diary
$ $ $$
Lab Systems

???
ODM SDS ADaM
Data Streams /
Databases CDISC
CDISC  BENEFITS
 CDISC  Benefits
CDISC  Benefits  

•Within  an  organization

•Between  an  organization
•Corporation
•Regulatory  bodies
•Data  Management
Benefits:  Within  an  Organization
-­‐ Improve  consistency  and  efficiency
-­‐ Enhance  critical  timings
-­‐ Concentrate  on  scientific  nature  of  data  rather  than  structure  of  data
Benefits:  between  an  Organization
-­‐ Leverage  synergies
.  Sponsor-­‐to-­‐sponsor,   vendor-­‐to-­‐sponsor,   etc.
.  Sponsor-­‐to-­‐Regulatory   Agency
Benefits:  Corporation
-­‐ SDTM  approved   by  FDA  
-­‐ SDTM  FDA  preferred  way  of  submitting   clinical  study  data  <>  Speed  up  registration  
process
-­‐ Streamlining   data  flow  and  data  interchange  between  partners  and  providers
-­‐ Standardization  saves  time  due  to  controlled   processes  at  Data  Management
 Benefits:  Regulatory  Bodies
-­‐ Reviewers  trained  in  use  of
ü Standardized  datasets
ü Standard  software  tools
ü More  effectively  work  the  data
-­‐ Facilitates  development  of  repository  of  clinical  data  (FDA)
Benefits:  Data  Management
-­‐ Provides  conventions  for  
ü Standardized  naming   of  variables  
ü Standardized  naming   of  datasets  
ü In  future:   Controlled  Terminology   (formats)
Remember

Not  a  rigid  model!

CDR  FRAMEWORK &  CDISC  MODELS
 CDR  Framework  
SOURCE STAGING  O F  DATA CDW DISTRIBUTION PRESENTING

Un-­ Structured  
Data

IVRS   SAS  Datasets  

Documents for  Analysis
E2B  Format Statistician
Customized  Adapters

CRO  Data
Data  Archival
Clinical  Data
EDC  Data
Trial  Admin  
Data
Data  Review  
Safety  Data Data  Reviewer
Tool
Structured  Data

CDW  
Patient  Data
Staging   CDISC   Staging   Repository
Area  1   Engine   Area  2  
(XML) Gateway (ODM)
AERS  Data
Reports  &  
Adhoc   Reporting  Users
Coding   Reporting
System

Dictionary  &   CDW  Metadata

Thesaurus
Validation   as  per  21CFR  Part11
Cross  Operational  Services  
Prescription  
1.  Scheduling   2.  Audit   Trial  3.  QA
Data
4.  ETL   /  CDW   Administration,  5.  Role  based   Privileges
CDISC  Models

• 9  models:  PRM,  CDASH,  SEND,  SDTM,  ODM,  LAB,  ADaM,  CRTM,  BRIDG

• developed  by  specialized  teams  with  initial  focus  on  functionality

• focused  on  harmonization  and  interoperability

– between  CDISC  models
– other  standards,  e.g.  HL7

Company   Confidential.  Copyright   ©  2007  

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LAXAI
 CDR  Framework  &  CDISC  Model
SOURCE STAGING  O F  DATA CDW DISTRIBUTION PRESENTING

Un-­ Structured  
Data

IVRS   SAS  Datasets  

Documents LAB for  Analysis
E2B  Format
ADaM Statistician
Customized  Adapters

CRO  Data
Data  Archival
CDASH SEND
Clinical  Data
EDC  Data ODM Trial  Admin  
Data
Data  Review  
Safety  Data Data  Reviewer
Tool
Structured  Data

CDW  
Patient  Data
Staging   CDISC   Staging   Repository
Area  1   Engine   Area  2  
AERS  Data
(XML) Gateway (ODM) SDTM
Reports  &  
Adhoc   Reporting  Users
Coding   Reporting
System CRTM
Dictionary  &   CDW  Metadata
Thesaurus
Validation   as  per  21CFR  Part11
Cross  Operational  Services  
Prescription  
1.  Scheduling   2.  Audit   Trial  3.  QA
Data
4.  ETL   /  CDW   Administration,  5.  Role  based   Privileges
QUESTIONS?
Thank  You