1. CDASh : A Primer and Guide to Implementation
Mark Wheeldon
NJ CDISC User Group
Merck, Summit
September 19, 2013

2. What is CDASH? What it is not Perfect libraries with CDASH
AGENDA
Introduction
What is CDASH? What it is not
Perfect libraries with CDASH
CDASH with multi-EDC vendors
CDASH aids mapping to SDTM
Practical CDASH mapping examples
Conclusions

3. Vendor neutral using CDISC since 2000
Introduction
Vendor neutral using CDISC since 2000
Save time & money in End-to-End Clinical Trial
Universal Design with Formedix Origin™
Data Acquisition Design & Dataset Design
Origin Study and Submission Modeller™
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Data Acquisition – Paper, EDC, ePRO & IVRS
Conversion – ETL
Submission – Annotated CRF and Define.pdf
Create once work with all. Train in one work in all
Formedix Consult™ Consultancy Services
Planning, preparation, implementation, multi-EDC execution
Won 2 CDISC awards – wrote much of ODM/define
The promise is Universal Execution across all systems, all vendors, in any format….
Transform for Data Acquisition
Transform for Conversion
Transform for Submission
Need to find away to put in all EDC vendors – or not use Fiona’s slides from video presentation …

4. INTRODUCTION TO CDASH

5. What it is not Content Standard NOT a Model
What is CDASH? What it is Not
Content Standard NOT a Model
Covers 22 core Case Report Forms (CRFs)
Variable Names, Definition, Question Text
Instructions to the Site, SDTM Variable Mapping
Core Designations is a killer feature
Give clinical context on why something is collected
Highly recommended, recommended/conditional, optional
Clinical Perspective on data collection
What it is not
One-to-one mapping with the SDTM
AEYN not in SDTM, AEBODSYS not in CDASH

6. Excel, Word, PDF Libraries
How CAN CDASH BE Stored?
Excel, Word, PDF Libraries
Excel for database metadata
Word for CRF mock-ups
Global proprietary EDC Library
Rave, DataLabs, Prism…
Has shortcomings
Lack of full support for CDISC
No alias support – automate aCRFs
No discrete measurement units support
Poor support for vertical structures
Optimal solution CDASH in CDISC-ODM

7. What is CDASH ODM? Submission Clinical Context Database Content
and Structure
Codelists
Structure
Extended ODM

8. CDISC Saves Time & Money
Libraries – Content Reuse
70% reuse
Standards maintenance resources down by 23%
Just this use case ROI – 8 months
Study Set-up
Specification auto-generation
Boston Scientific proved a 68% reduction
With CROs, Partners, EDC vendors ….
Study Build
Automate EDC build build
55% reduction in EDC build
Study Conduct and Analysis
76% reduction in dataset production

9. Perfect Libraries with CDASH

10. 36 4 8 10 5 15 6 342 143 = 36 FORMS CASE STUDY - CDASH not used
STUDIES IN SAME THERAPEUTIC AREA
MIXTURE OF EDC/CRO
VENDORS
342
FORMS
143
UNIQUE FORMS 36
FORMS
WITHOUT CDASH 4
MASTER LIBRARY FORMS WITH CDASH
Multiple permutations of Forms present 10
MEDICAL
HISTORY
FORMS 5
SURGICAL 15
VITAL
SIGNS 6
PHYSICAL
EXAM
= 36 FORMS

11. CRF Reuse Before & After
STUDY
% REUSE 1 2 36 3 52 4 71 5 80 6 90
STUDY
% REUSE 1 48 2 70 3 94 4 80 5 86 6
100
WITHOUT CDASH
WITH CDASH
Use study 1 as a library
Add each ‘new' form from study to study
Do not standardize
End-to-end reuse low until final studies
Standardize common forms
66 vs. 142 unique forms
22 CDASH forms
End-to-end reuse high in early studies

12. Example DM CRF

13. Study specific demographics
CDASH LIBRARY – MASter DEMOGRAPHICS EXAMPLE

14. Quality is built in up-front not tested in
CDISC Models and CDASH Content
Perfect Reuse Everywhere.
Quality is built in up-front not tested in
CDISC Libraries with CDASH Content
Clinical context – quicker clinician approval
Vendor neutral and portable
Design once
Everything pre-approved so review reduced
Only test new content or changed content
Standardized CRFs = consistent data collection
Standardized CRFs = standardized datasets/mappings
Reuse of all study design components
Across end-to-end clinical trial
Across multiple vendors & data capture systems

15. CDASH with
multi-EDC vendors

16. CDASH Multi-Vendor eCRFs Autogenerated

17. Poor/Lack of support for
Implementation Issues -
cdash WITH multi-EDC vendors
Structural Issues
CDASH vertical vs. EDC horizontal
EDC systems allow only one vertical structure
Poor/Lack of support for
CDISC identifiers - lengths, character restrictions etc.
Aliases – used to annotate/map to SDTM, Legacy fields ...
Multiple languages
Enumerated codelists
Worst case
‘Hard coded’ CRFs required for EDC Demographics, Labs, AE etc.

18. Code / decode instead of enumerated codelist
Implementation Issues -
SOLUTIONS
Structural
Implement one field per question (horizontal)
Implement vertical versions
Split repeating sections on separate forms (incl/excl)
Core Libraries
Covers most use cases
Special case specific EDC eCRFs in separate library
Global aliases
Company corporate identifiers used end-to-end everywhere
Still supports EDC identifier restrictions
Code / decode instead of enumerated codelist

19. Mapping CDASH to SDTM

20. Advantages of CDASH Aligns CRF to SDTM Datasets
Aligns Controlled Terms to SDTM Controlled Terms
<Graphic Of CRF to SDTM Domain alignment>

21. Selection of CDISC Standard Domains Map to CDASH
Interventions
Findings
CM (Concomitant Medications)
EG (ECG)
IE (Inclusion / Exclusion Exceptions)
EX (Exposure)
SU (Substance Use)
LB (Laboratory Test Results)
PE (Physical Examination)
Events
QS (Questionnaires)
AE (Adverse Events)
SC (Subject Characteristics)
DS (Disposition)
VS (Vital Signs)
MH (Medical History)
Special Purpose
DM (Demographics)
CO (Comments)

22. CDASH ODM CDASH & SDTM Alignment CDASH CRF Label Question
SDTM Controlled Terminology
SDTM Variable Name
CDASH Core
(Highly Recommended)

23. Optimizing Downstream Dataflows1 6 4 5 2 3 1 2 3 4 5 6
Non-CDASH Form
CDASH Form

24. Optimizing Downstream Dataflows1 2 3 4 5 6
CDASH
Non-CDASH

25. Vertical Needs Help Sometimes
Pure CDASH :
Vertical Needs Help Sometimes
Vital signs (VS form)
Vertical implementation suggested
Optimized for dataset production and not all easy to enter data.
Must repeat on VSTEST.
Cannot have repeat on time as well
Form repeats for time points
Other issues
Every variable collected at every time point even if likely to remain constant
VSORRESU Units must be a pull down
Error prone needs more edit checks
Repeated collection of irrelevant values
Pros: Simple dataset mapping

26. CRF - SDTM DATA MAPPING Horizontal - vertical ° ° C BPM CRF
TEMPERATURE C
TEMP.
BPM
PULSE
USUBJID
TEMP
TEMP_U
PULSE
PULSE_U
1001
38.0 C 82
BPM
1002
38.5 79
COLLECTION DB
USUBJID
VSTESTCD
VSORRESU
1001
TEMP
BPM
PULSE
VSORRES C
38.0 82
1002
38.5 79
SDTM DATASET
COLLECTION DB
USUBJID
TEMP
TEMP_U
PULSE
PULSE_U
1001
38.0 C 82
BPM
1002
38.5 79

28. CDASH ODM is best format to store CDASH
Conclusions
CDASH ODM is best format to store CDASH
Union of all standards
SDTM, ODM, CT
EDC extensions and best practices
CDASH saves time and money
Clinical perspective
Promotes reuse of CRFs and end-to-end designs
Alignment with SDTM and mapping ease
Compromises have to be made
Multi-vendor and your own content
No two CDASH libraries are identical

29. ANY QUESTIONS?