1. Rhonda Facile Project Leader, CDISC
CDASH Initiative
CDASH Project Description &
Status
Rhonda Facile
Project Leader, CDISC

2. CDASH Project Process Outline Background and Charter CDISC COP 001
Project Organization
Project Process
SDTM
Review of Progress
Next Steps
Activities & Project Notes
Accomplishments to Date
Future
Core Team Contact

3. CDASH Project Process C-path opportunity #45
Continues ACRO’s CRF Standardization Initiative
Project Charter
To develop a set of ‘content standards’ (element name, definition, metadata) for a basic set of global data collection fields that will support clinical research studies. The initial scope will be the ‘safety data domains’ to support clinical trials.
These safety domains cut across all therapeutic areas, beginning with domains.
CDISC COP (COP-001)
Follow the CDISC COP Standards Process (COP-001)

4. CDISC Standards Development Process (COP-001) Primary Stages
Stage I: Standard Definition/Approval
Multidisciplinary Team Initiation; Working Plan Development
Stage II: Standards Development-Consensus Model;
Reviews by External Focused Group and Open Public;
Harmonization and Testing throughout; V1.0 Release
Stage III: Education & Support
Stage IV: Standards Update & Maintenance

5. Standards Development Process for CDISC (COP-001)
Current Status
Stage I: Standard Definition/Team Initiation
Need for
Specific
Standard(s)
Identified
(any stakeholder)
Proposal
to Board
of Directors
(via OIS)
Review per
strategy, budget
priorities
Team Leader ID
And Team
Formation
(multidisciplinary)
(OIS)
Working Plan
(timelines, deliverables
communication mech.,
resources req’d)
(Team )
Approved
Not Approved
Stage II: Standards Development/Review/V 1.0 Release
Consensus
(Initial)
Version
Harmon-
ized
Version
Testing
Review
Version
Released
(Production)
Version
1.0
Comments addressed OK
PSCC
Review Ex
Focused
Review
Public
Review OK
Comments to address by team
Stage III: Education & Support
Respond
To Comments
And Questions
Educational
Programs
(EDU, OIS)
Stage IV: Standards Update & Maintenance
SPCC
Review
New Released
(Production)
Version
Annual Review of Released Version
(comments, chg reqsts, tests, plans) (Team)
Working Plan (timelines, deliverables, communication mech., resources req’d) (Team)
Consensus (Revised) Version
Harmon- ized
Version
Public Review as needed
Optional Ex
Focused
Review
Note: Occasional bug fix releases may be
issued as needed with team review only.

6. Achieving Global Consensus
Project Organization
Collaborative Group
CDISC TAC
Core
Team
(n=9)
Stream Members

7. Achieving Global Consensus
Project Organization
Streams must ensure input from all relevant functions:
Statisticians
Data Managers
Clinical Study Coordinators
Clinical Research Associates
Investigators
Clinical Program Managers
Both US and EX-US
Volunteers affiliated with global organizations are asked to include ex-US input into their stream’s standards development process.
Need more representation from
these functions
Need more ex-US Representation.

8. Achieving Global Consensus
Participants in the CDASH Initiative
Other = Academic Research Organizations (1), Government (NIH, NCI (2)), Hospitals (2), Universities (14),
Military (1)

9. CDASH Project Process Process (1) SDTM Variable Tables
Start with SDTM Data Variable Tables
Use mandatory SDTM variables as a basis for the CDASH review process.
Refer to ACRO CRF Samples when available
Focus on CRF Content, not CRF Layout
SDTM Variable Tables

10. CDASH Project Process Process (2) Collect CRF samples
Evaluate commonalities/differences of CRF samples and SDTM
Document data points included/excluded with justifications
Guiding principles: variables should –
Start with the current SDTM Implementation guide & tables
Make sure all SDTM required elements are included either directly or indirectly
Be “standard” but flexible to allow customization within defined limits
Limit variables to required and necessary
Comply with regulatory requirements
Reduce redundancies; Not duplicate information found elsewhere in CRFs
Increase collection of meaningful data
Facilitate use of standards by all users
Be appropriate for use both pre and post approval studies
Allow consistent and efficient data collection/storage/transmission and analysis

11. CDASH Project Process Technical Leadership Committee (TLC)
Process Deliverables (3)
Reach agreement on BASIC (mandatory) CRF Data Elements
Map to SDTM using SDTM variable names (leveraged from the SDS Team)
Add Controlled Terminology (leveraged from the Terminology Team)
Add definitions
Write completion guidelines/instructions
Proceed to the next step in the Consensus Process as specified in COP-001
Technical Leadership Committee (TLC)

12. Achieving Global Consensus
Detailed Consensus process
Stage II: Standards Development/Review/V 1.0 Release
Per Domain
Consensus
(Initial)
Version
Harmon-
ized
Version
Testing
Review
Version
Released
(Production)
Version
1.0
Comments addressed OK
TLC
Review
Collaborative
Group
Review
Public
Review OK
Comments to address by team
~3 months
~1 week
~1 month
~1 month
Ask Collaborative Group if they can serve as the External Focused Review Group.
~1 month
~1 month
~1 month
Entire process takes ~ 8 months

13. CDASH Process DM CO CM SU EX AE MH DS DV DA IE PE SC VS Process (4)
SDTM Domains
DM CO CM SU EX AE MH DS DV DA IE PE SC VS
SDTM
Basic CRF
Elements
CDASH Process
Subsets
Vetted by
“Front End”
Stakeholders
(Streams
comprised
of Invs, CRAs,
Data Managers,
Statisticians,
etc.) DM CO CM SU EX AE MH DS DV DA IE PE SC VS
2) Add
SDTM
Variable
Names
3) Add CT
Subset
of 1)Basic
Data
Collection
Elements
from
SDTM
Domains
1) ”Basic Data Collection (CRF) Elements” = data elements that cut across all therapeutic areas and apply to most clinical trials. Leveraged from work done by the SDS team, collection of CRFs samples etc.
2) SDTM Variable Names; leveraged from work done by the SDS team.
3) CT = Controlled Terminology; leveraged from the work done by the Terminology Team.

14. The AE, CM, DM and SC Streams have delivered
CDASH Project Process
Progress
The AE, CM, DM and SC Streams have delivered
their Initial Consensus Versions (ICV). The following slides show the basic (mandatory) CRF data collection elements identified by the streams.
Note: Conditional and optional data elements were also identified and included in the ICVs, however the initial remit is to focus on the basic data elements.

15. Collection (CRF) Elements
AE – Basic Data Collection Elements
SDTM Data Variables
CDASH *Basic Data
Collection (CRF) Elements
AEPTT
AEOUT
AESCAN
AESCONG
AESDISAB
AESDTH
AESHOSP
AESLIFE
AESOD
AESMIE
AECONTRT
AETOXGR
AESTDTC
AEENDTC
AESTDY
AEENDY
AEDUR
AEENRF
AESEQ
AEGRPID
AERIFID
AESPID
AETERM
AEMODIFY
AEDECODE
AECAT
AESCAT
AEOCCUR
AEBODSYS
AELOC
AESEV
AESER
AEACN
AEACNOTH
AEREL
AERELNST
AETERM
AESTDTC
AEENDTC
AESER
AESDTH
AESHOSP
AESLIFE
AESOD
AESMIE
AESEV
AETOXGR
AEREL
AEACN
AEOUT
(n=36)
(n=14)
*Basic = Mandatory

16. Collection (CRF) Elements
CM – Basic Data Collection Elements
SDTM Data Variables
CDASH *Basic Data
Collection (CRF) Elements
CMSEQ
CMGRPID
CMSPID
CMTRT
CMODIFY
CMDECODE
CMCAT
CMSCAT
CMOCCUR
CMSTAT
CMREASND
CMINDC
CMCLAS
CMCLASCD
CMDOSE
CMDOSTXT
CMDOSU
CMDOSFRM
CMDOSFRQ
CMDOSTOT
CMDOSRGM
CMROUTE
CMSTDTC
CMENDTC
CMSTDY
CMENDY
CMDUR
CMSTRF
CMENRF
CMTRT
CMSTDTC
CMSTRF
CMENDTC
CMENRF
(n=29)
(n=5)
*Basic = Mandatory

17. Collection (CRF) Elements
DM & SC – Basic Data Collection Elements
SDTM Data Variables
CDASH *Basic Data
Collection (CRF) Elements
BRTHDTC
AGE
AGEU
SEX
RACE
ETHNIC
ARMCD
ARM
COUNTRY
DMDTC
DMDY
BRTHDTC
Year of Birth
Month of Birth
SEX
RACE
(n=11)
(n=3)
*Basic = Mandatory

18. Collaborative Group Review
CDASH Project Process
1st set of domains
Started work during the Project Kick-off meeting, 18 October 2006 at SAS Institute, Cary, NC.
Deliverables to complete TLC review by ~middle of March.
Collaborative Group review to start ~end of March/beginning of April.
ICV
TLC Review
Harmonized Version
Collaborative Group Review
Reviewed Version
Public Review
Released Version 1.0 AE
Dec. 2006
March 2007
March – April 2007
April 2007
Q108
Q2 2008 CM
Jan 2007
DM & SC
Jan. 2007

19. Initial Consensus Version Collaborative Group Review
CDASH Project Process
2nd set of domains
Started in December 2006.
Delivered ICVs end of February 2007.
TLC review to start beginning of March.
Initial Consensus Version
TLC Review
Harmonized Version
Collaborative Group Review
Reviewed Version
Public Review
Released Version 1.0
INC/EX
February
2007
March – April 2007
April 2007
May – June 2007
June 2007
Q108
Q2 2008
MH & SU
February 2007
PE & VS

20. Initial Consensus Version Collaborative Group Review
CDASH Project Process
Initial Consensus Version
TLC Review
Harmonized Version
Collaborative Group Review
Reviewed Version
Public Review
Released Version 1.0
Adverse
Events
December 2006
March 2007
March – April 2007
April 2007
Q108
Q2 2008
Prior & Concomitant Medication
January 2007
Demographics & Subject Characteristics
Inclusion/Exclusion Criteria
February 2007
May – June 2007
June 2007
Medical History and Substance Use
Physical Exam & Vital Signs
End of Study/
Disposition
May 2007
June – July 2007
July 2007
August – Sept. 2007
September 2007
Drug Accountability/
Exposure
Protocol Deviations/
Comments
Lab & ECG
August 2007
September-October 2007
October 2007
November-
December 2007
January 2008

21. CDASH Project Process
The 3rd set of domains (DA& EX, CM & DV, End of Study/DS) will be initiated at the beginning of March.
4th set of domains (Lab & ECG) to start beginning of June.

22. CDASH Project Status - March 2007

23. Achieving Global Consensus
CDASH Activities & Project Notes
Webinar - Held 22 January.
Press Release – soon!
Teleconferencing – continues q2 weeks
Core Team contacts – frequent, TCs q 2 weeks.
CDASH web portal - up and used. To expand access to new streams.
CDISC web site – a valuable source of info. Will facilitate public review phase of project.

24. Achieving Global Consensus
Accomplishments to Date:
Successful Kick-off meeting (October 2006)
List of over 260 volunteers (varying degrees of participation)
Initiation of 1st set of domains
Delivery of ICVs for 1st set of domains
Initiation of 2nd set of domains
CDASH web portal – up
Successful CDASH Webinar held (333 Attendees – 53 International)
Delivery of ICVs for 2nd set of domains
Initiation of 3rd set of domains

25. CDASH Project Process Future? Standardize layout
Standardize edit language
Standardize basic therapeutic area standards?
Support CDISC Forum/Help Desk
New Domains to be “CDASHed”
Update of CDASH developed domains
SLs and Stream Members to support TLC in future reviews of new standards

26. Achieving Global Consensus
CDASH Core Team Contact Information
Rhonda Facile
Gary Walker
Dorothy Dorotheo
David E. Tatum
Paul Bukowiec
Trisha Simpson
Shannon Labout
Liz Nulton-Bodiford
Jay Leeka
Alec Vardy

27. Achieving Global Consensus
Thanks to all the CDASH project volunteers for their time and commitment to the CDASH Project.