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
26
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
