Transcript Slide 1

CDASH Initiative
CDASH Project Description &
Status
Rhonda Facile
Project Leader, CDISC
CDASH Project Process
• Outline
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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
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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 12-14 domains.
CDISC COP (COP-001)
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Follow the CDISC COP Standards Process (COP-001)
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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
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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)
Team Leader ID
And Team
Approved
Formation
(multidisciplinary)
(OIS)
Review per
strategy, budget
priorities
Working Plan
(timelines, deliverables
communication mech.,
resources req’d)
(Team )
Not Approved
Stage II: Standards Development/Review/V 1.0 Release
Testing
Consensus
(Initial)
Version
Harmonized
Version
PSCC
Review
Comments addressed
OK
Ex
Focused
Review
OK
Review
Version
Released
(Production)
Public
Review
Version
1.0
Comments to address by team
Stage III: Education & Support
Respond
To Comments
And Questions
Educational
Programs
(EDU, OIS)
Stage IV: Standards Update & Maintenance
Annual Review of
Working Plan
Released Version
(timelines, deliverables,
(comments, chg
communication mech.,
reqsts, tests, plans)
resources req’d)
(Team)
(Team)
Consensus
(Revised)
Version
SPCC
Review
Optional
Ex
Focused
Review
Harmonized
Version
Public
Review
as
needed
Note: Occasional bug fix releases may be
issued as needed with team review only.
New
Released
(Production)
Version
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Achieving Global Consensus
Project Organization
Collaborative Group
CDISC TAC
CDISC Project
Director
Rhonda Facile
(n=9)
Stream Leader
AE
Dave Tatum
Lilly
Stream Leader
PM & CM
Dorothy Dorotheo
InterMune
Stream Leader
DM & SC
Lab & ECG
Gary Walker
Quintiles
Stream Leader
Med HX
Trisha Simpson
Schwarz Biosciences
Stream Leader
Inc/Exc
Shannon Labout
CSS Informatics
& SCDM
Stream Leader
PE & VS
Paul Bukowiec
Millennium
Pharmaceuticals
Stream Leader
End of Study
/Disposition
Alex Vardy
CVT Therapeuticals
Stream Leader
Drug Accountability/
Exposure
Liz Nulton-Bodiford
GlaxoSmithKlein
Stream Leader
Protocol Deviations
& Comments
Jay Leeka
AstraZeneca
Core
Team
Stream Members
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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
Need more representation from
these functions
Need more ex-US Representation.
Volunteers affiliated with global organizations are asked to include exUS input into their stream’s standards development process.
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Achieving Global Consensus
Participants in the CDASH Initiative
Other
18%
Biotech
8%
CROs
42%
Pharma
32%
Other = Academic Research Organizations (1), Government (NIH, NCI (2)), Hospitals (2), Universities (14),
Military (1)
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CDASH Project Process
Process (1)
SDTM Variable Tables
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Start with SDTM Data Variable Tables
Use mandatory SDTM variables as a basis
for the CDASH review process.
Variable
Label
Variable Name
STUDYID
USUBJID
Study Identifier
Unique Subject
Identifier
Inclusion/Exclusion Verbatim description of
Criterion
the inclusion or exclusion
IETEST
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Refer to ACRO CRF Samples when
available
Focus on CRF Content, not CRF Layout
IEORRES
VISIT
IEDTC
IEDY
Text of incl/excl
criteria taken from
protocol**
I/E Criterion
Original Result
Definition
Termin Metadata
ology*
Regulatory
Completion
Requirements Instructions
(if applicable)
criterion that was the
exception for the subject
within the study.
Original response to
Inclusion/Exclusion
Criterion question.
Inclusion or Exclusion
criterion met?
Visit Name
Date/Time of
Collection
Study Day of
Collection
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CDASH Project Process
Process (2)
•
Collect CRF samples
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Evaluate commonalities/differences of CRF samples and SDTM
•
Document data points included/excluded with justifications
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Guiding principles: variables should –
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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
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CDASH Project Process
Process Deliverables (3)
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Reach agreement on BASIC (mandatory) CRF Data Elements
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Map to SDTM using SDTM variable names (leveraged from the SDS Team)
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Add Controlled Terminology (leveraged from the Terminology Team)
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Add definitions
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Write completion guidelines/instructions
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Proceed to the next step in the Consensus Process as specified in COP-001
Technical Leadership Committee (TLC)
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Achieving Global Consensus
Detailed Consensus process
Stage II: Standards Development/Review/V 1.0 Release
Per Domain
Testing
Consensus
(Initial)
Version
TLC
Review
Harmonized
Version
Comments addressed
OK
Collaborative
Group
Review
OK
Review
Version
Released
(Production)
Public
Review
Version
1.0
Comments to address by team
~1 week
~3 months
~1 month
~1 month
~1 month
~1 month
~1 month
Entire process takes ~ 8 months
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Process (4)
SDTM Domains
DM
CO
CM
SU
EX
AE
MH
DS
DV
DA
IE
PE
SC
VS
SDTM
Basic CRF
Elements
Subset
of 1)Basic
Data
Collection
Elements
from
SDTM
Domains
Subsets
Vetted by
“Front End”
Stakeholders
(Streams
comprised
of Invs, CRAs,
Data Managers,
Statisticians,
etc.)
2) Add
3) Add
SDTM
CT
Variable
Names
DM
CO
CM
SU
EX
AE
MH
DS
DV
DA
IE
PE
SC
VS
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.
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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.
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AE – Basic Data Collection Elements
SDTM Data Variables
AESEQ
AEGRPID
AERIFID
AESPID
AETERM
AEMODIFY
AEDECODE
AECAT
AESCAT
AEOCCUR
AEBODSYS
AELOC
AESEV
AESER
AEACN
AEACNOTH
AEREL
AERELNST
AEPTT
AEOUT
AESCAN
AESCONG
AESDISAB
AESDTH
AESHOSP
AESLIFE
AESOD
(n=36)
AESMIE
AECONTRT
AETOXGR
AESTDTC
AEENDTC
AESTDY
AEENDY
AEDUR
AEENRF
CDASH *Basic Data
Collection (CRF) Elements
AETERM
AESTDTC
AEENDTC
AESER
AESDTH
AESHOSP
AESLIFE
AESOD
AESMIE
AESEV
AETOXGR
AEREL
AEACN
AEOUT
(n=14)
*Basic = Mandatory
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CM – Basic Data Collection Elements
SDTM Data Variables
CMSEQ
CMGRPID
CMSPID
CMTRT
CMODIFY
CMDECODE
CMCAT
CMSCAT
CMOCCUR
CMSTAT
CMREASND
CMINDC
CMCLAS
CMCLASCD
CMDOSE
CMDOSTXT
CMDOSU
CDASH *Basic Data
Collection (CRF) Elements
CMDOSFRM
CMDOSFRQ
CMDOSTOT
CMDOSRGM
CMROUTE
CMSTDTC
(n=29)
CMENDTC
CMSTDY
CMENDY
CMDUR
CMSTRF
CMENRF
CMTRT
CMSTDTC
CMSTRF
CMENDTC
CMENRF
(n=5)
*Basic = Mandatory
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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
(n=11)
•Year of Birth
•Month of Birth
(n=3)
SEX
RACE
*Basic = Mandatory
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CDASH Project Process
1st set of domains
ICV
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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.
TLC
Review
Harmon
ized
Version
Collabo
rative
Group
Review
Review
ed
Version
Public
Review
Release
d
Version
1.0
AE
Dec.
2006
March
2007
March
2007
March –
April
2007
April
2007
Q108
Q2 2008
CM
Jan
2007
March
2007
March
2007
March –
April
2007
April
2007
Q108
Q2 2008
DM & SC
Jan.
2007
March
2007
March
2007
March –
April
2007
April
2007
Q108
Q2 2008
Collaborative Group
review to start ~end of
March/beginning of April.
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CDASH Project Process
Initial
Consen
sus
Version
TLC
Review
Harmo
nized
Versio
n
Collabo
rative
Group
Review
Review
ed
Version
INC/EX
February
2007
March
– April
2007
April
2007
May –
June
2007
MH &
SU
February
2007
March
– April
2007
April
2007
PE &
VS
February
2007
March
– April
2007
April
2007
2nd set of domains
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Public
Review
Release
d
Version
1.0
June
2007
Q108
Q2
2008
May –
June
2007
June
2007
Q108
Q2
2008
May –
June
2007
June
2007
Q108
Q2
2008
Started in December 2006.
Delivered ICVs end of
February 2007.
TLC review to start
beginning of March.
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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 2007
March – April
2007
April 2007
Q108
Q2 2008
Prior & Concomitant
Medication
January 2007
March 2007
March 2007
March – April
2007
April 2007
Q108
Q2 2008
Demographics &
Subject
Characteristics
January 2007
March 2007
March 2007
March – April
2007
April 2007
Q108
Q2 2008
Inclusion/Exclusion
Criteria
February 2007
March –
April 2007
April 2007
May – June
2007
June 2007
Q108
Q2 2008
Medical History and
Substance Use
February 2007
March –
April 2007
April 2007
May – June
2007
June 2007
Q108
Q2 2008
Physical Exam &
Vital Signs
February 2007
March –
April 2007
April 2007
May – June
2007
June 2007
Q108
Q2 2008
End of Study/
Disposition
May 2007
June – July
2007
July 2007
August –
Sept. 2007
September
2007
Q108
Q2 2008
Drug Accountability/
Exposure
May 2007
June – July
2007
July 2007
August –
Sept. 2007
September
2007
Q108
Q2 2008
Protocol Deviations/
Comments
May 2007
June – July
2007
July 2007
August –
Sept. 2007
September
2007
Q108
Q2 2008
Lab & ECG
August 2007
SeptemberOctober
2007
October 2007
NovemberDecember
2007
January 2008
Q108
Q2 2008
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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.
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CDASH Project Status - March 2007
Q4 2006
Oct
Adverse Events
Nov
Dec
Q1 2007
Jan
Feb
Q2 2007
Mar
Apr
May
Q3 2007
Jun
Jul
Aug
Q4 2007
Sep
Oct
Nov
Dec
Q1 08
Jan
Feb
Mar
ICV
Prior Medication
ICV
Concomitant Medication
ICV
Demographics
ICV
Subject Characteristics
ICV
Physical Examination
ICV
Vital Signs
ICV
Medical History
ICV
Substance Use
ICV
Inclusion/Exclusion
Criteria
Exposure/
Drug Accountability
Comments/
Protocol Deviations
Disposition/
End of Study
ICV
ICV
ICV
ICV
Lab
ICV
ECG
ICV
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Achieving Global Consensus
CDASH Activities & Project Notes
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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.
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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
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CDASH Project Process
Future?
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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
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Achieving Global Consensus
CDASH Core Team Contact Information
• Rhonda Facile
[email protected]
• Gary Walker
[email protected]
• Dorothy Dorotheo
[email protected]
• David E. Tatum
[email protected]
• Paul Bukowiec
[email protected]
• Trisha Simpson
[email protected]
• Shannon Labout
[email protected]
• Liz Nulton-Bodiford [email protected]
• Jay Leeka
[email protected]
• Alec Vardy
[email protected]
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Achieving Global Consensus
Thanks to all the CDASH project volunteers for their time
and commitment to the CDASH Project.
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