Introducing

the CDISC Standards

New Efficiencies for Medical Research

A C D I S C P U B L I C AT I O N
 Introducing the CDISC Standards:
New Efficiencies for Medical Research
PREFACE
 INTRODUCTION

i. Myths about Standards

ii. Medical Research An Industry in Crisis

iii. Standards Assisting Healthcare
iv. Benefits of Implementing CDISC Standards
& the Business Case

Note: Figures are benchmarks based on aggregate data;

study specific cycle times and cost metrics will vary
v. CDISC Standards for All
vi. The Technical Strategy and Overview
Design Execute Analyse & Submit

Protocol CDASH SDTM

ADaM
LAB (SEND)

CDAS
SDTM
Protocol H (SEND)
ADaM
LAB

Transport


Biomedical Research Integrated Domain Model (BRIDG)

CDASH SDTM
Protocol ADaM
LAB (SEND)
 THE CDISC STANDARDS

i. The CDISC Standards Data Flow

ii. Data and Metadata
iii. How are the Standards Developed?
THE CDISC CLINICAL RESEARCH GLOSSARY

All Standards

Healthcare Link
PROTOCOL REPRESENTATION

ODM

CDASH

Healthcare Link (BRIDG)

SDTM including the Trial Design Model

Summary of Study Design FORM: Bolded,
Arial, 11pt,
Heading level 1
This is a prospective, randomized,
double-blind, double-dummy, placebo
controlled, forced-titration, multicentre,
parallel group trial. Stage I or II FORM: Bolded,
hypertensive patients, age 18 years of Arial, 11pt,
age or older, who meet all other Body Text
inclusion and exclusion criteria and
successfully complete the placebo run-in
period will be randomized at the site
level.
Age 18 years of age or older,
Parallel group trial
Stage I or II hypertensive patients
double-blind
CLINICAL DATA ACQUISITION STANDARDS
HARMONIZATION - CDASH

Healthcare Link

Protocol Representation

SDTM

Terminology
To develop a set of content standards
(element name, definition, metadata) for
The initial scope to develop 16 safety
data domains.
These safety domains are common to all
therapeutic areas.
Follow CDISC Operating Procedure for
Standards Development (see the


THE OPERATIONAL DATA MODEL - ODM

Protocol

CDASH

Healthcare Link
<CDCollection>
Structure
<CD TotalTime="45.02">
<Artist>Pink Floyd</Artist>
<Title>Dark Side of the Moon</Title>
<Track Label="1a">Speak To Me</Track>
<Track Label="1b">Breathe</Track> Element
<Track Label="2">On the Run</Track>
<Track Label="3">Time</Track>
Attribute
<Track Label="4">The Great Gig in the Sky</Track>
<Track Label="5">Money</Track>
<Track Label="6">Us and Them</Track>
<Track Label="7">Any Colour You Like</Track>
<Track Label="8">Brain Damage</Track>
<Track Label="9">Eclipse</Track>
</CD>
</CDCollection>
Site Details

Site No.: ___5___

Subject's Characteristics ODM

Number: __12___
XML
Sex: M [Y] F[]

Height: ___1560__ cm
Site Details

Site No.: ___5___

Subject's Characteristics ODM

XML
Number: __12___

Sex: M [Y] F[]

15 cm
Height: ___1560__
6
AB

Data
Ad Correction made by the
physician

min

Site Yellow


THE CLINICAL LABORATORY DATA MODEL -

LAB

ODM

SDTM
SUBMISSION DATA STANDARDS: SDTM,
SEND, TRIAL DESIGN & DEFINE.XML

ADaM

Protocol

CDASH

BRIDG
i. SDTM


ii. Standard for the Exchange of Non-Clinical Data: SEND

Identifier
525
Variable
Topic Variable Body Weight

Timing Variable Study Day 6

Qualifier 250 grams

iii. Trial Design Model (TDM)


iv. Case Report Tabulation Data Definition Specification

(Define.xml)

v. Submission Data Models and the FDA
THE ANALYSIS DATA MODEL - ADAM

SDTM

CDASH

BRIDG
1 Facilitate clear and unambiguous communication
and provide a level of traceability

2 Be analysis ready (so that statistical analysis can be

performed with minimum programming)

3 Linked to machine readable metadata thereby

facilitating software development

4 Work with those tools that are currently available

 Doctor Documentation
Green
Data
Sources
Analysis
Dataset
Creation Protocol Analysis
Process Statistic Results
Metadata
al

Analysis
Dataset
Analysis Results
Generation
Process


STANDARD CONTROLLED TERMINOLOGY

All Standards

BRIDG
 American British

counterclockwise anticlockwise
semi-trailer arcticulated lorry
drugstore chemist
cart trolley
 Company 1 Company 2 Company 3

No Not related No
Unlikely Doubtful
Possible Possible
Probable Probable
Definite Very Likely Yes/Unknown
THE CDISC HEALTHCARE LINK INITIATIVE



i. Electronic Source Data Interchange (eSDI)
ii. Biomedical Research Integrated Domain Group: BRIDG
iii. Integrating the Healthcare Enterprise and the Retrieve
Form for Data Capture Profile
THE BIOMEDICAL RESEARCH INTEGRATED
DOMAIN GROUP (BRIDG) MODEL
 FDA HL7

NCI Academia

CDISC BBoD Pharma

caBIG HL7

CDISC FDA
BRIDG
THC
 Syntax Semantics

Describes the The meaning

structure of a conveyed by the
language language
HOW TO START IMPLEMENTING CDISC
STANDARDS


THE FUTURE FOR CDISC

 APPENDIX

i. Additional Reading and References

ii. CDISC Documents and Sources
iii. Useful Websites
 When there are so many pressures on time and finance
in the medical research industry, wouldnt it be help-
ful if the whole process was more efficient? What if
there was a standard method to collect data, exchange
data and submit data? Would that help you and your
organisation? If youre looking for answers, look no fur-
ther! For the first time, information about all the CDISC
Standards, the CDISC Healthcare Link Initiative and
much more can be found within this basic guide and
will help you get started.

CDISC Standards, the Key for Success

www.cdisc.org
CDISC 2009