Transcript Slide 1

CDASH Initiative: Status Update
Bay Area CDISC Implementation
Network Meeting - May 29, 2008
Rhonda Facile, Project Director, CDISC
Dorothy B. Dorotheo, InterMune
Mark Wheeldon, Formedix
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Snapshot Overview
CDASH Purpose & Scope
Who Participated in CDASH
How CDASH Developed?
CDASH Domains – Where are we?
CDASH Domains – New Ideas
CDASH Variable Metadata
CDASH Core Designations
Practical Implementation of CDASH within CDISC ODM
CDASH Goals
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Snapshot
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Critical Path Opportunity #45 –
Streamline data collection at
investigative sites.
Continuation of ACRO’s Initiative
Started October 2006
Supported by a Collaborative Group
of 17 organizations
Core team of 15 members manages..
• 11 working groups
• Groups with between 8-40
volunteers
~190 work group volunteers +
additional reviewers (both nationally
and internationally)
16 Safety data domains developed..
• organized in 4 “Packages”
Draft consolidated document now out
for public review – April 2008
Clinical Data Acquisition
Standards Harmonization: Basic Data Collection Fields for
Case Report Forms
Prepared by the CDISC CDASH Team
Notice to Reviewers
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This is the draft CDASH posted for comment.
Revision History
Date
2008-04-15
Version
Summary of Changes
Draft 1.0
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CDASH Purpose & Scope
 To develop a set of ‘content standards’ (element name,
definition, metadata) for a basic set of global industrywide data collection fields that support clinical research.
 The initial scope - ‘safety data/domains’.
 These safety domains cut across all therapeutic areas
(TA independent).
 Follow CDISC Operating Procedure for Standards
Development (COP-001).
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Who Participated in CDASH?
Team membership:
 Statisticians
 Medical Monitors/Clinical Scientists
 Regulatory Affairs
 Drug Safety
 Data Managers
 Clinical Study Coordinators
 Clinical Research Associates
 Investigators
 Clinical Program Managers
 Statistical Programmers
 Database programmers
More multi-national input welcome.
Participants in the CDASH Initiative
Other
18%
Biotech
8%
CROs
42%
Pharma
32%
Other = Academic Research Organizations,
Government (NIH, NCI), Hospitals, Universities.
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How was CDASH Developed?
 Start with Study Data Tabulated Model (SDTM)
 Focus on CRF Content, not CRF Layout
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 Refer to ACRO CRF Samples (where available)
 Collect CRF samples
 Evaluate commonalities/differences of CRF samples
 Document data points included/excluded with justifications
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How was CDASH Developed?
 Agree on basic data collection fields
 Map to SDTM
 Terminology - proposals shared with the Terminology Team
 Write definitions and completion instructions for clinical site and
Sponsors
 Proceed to the next step in the Consensus Process
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CDASH Domains – Where we are
Package-1:
AE
CM
DM
SC
Started Oct 06
Consensus
(Initial)
Version
TLC
Review
Package-2:
IE
MH
SU
PE
VS
Started Dec 06
Harmonized
Version
Package 3:
DA
EX
CO
DV
DS
Started Mar 07
Collaborative O
Group
K
Review
Review
Version
Package-4:
LB
EG
Started Jul 07
Released
(Production)
Public
Review
Version
1.0
Published & Out for Public Review – April 2008
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CDASH Variable Metadata
Question text
for collection
on the CRF.
Describes the
purpose of the
data collection
field
SDTM-IG
conforming
variable name
(CDASH
variables shaded)
Aka CRF
Completion
Instructions
How to
implement
the CRF
data collection
variable
CDASH
Core
Designations
CDASH Core Designations
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Highly Recommended
A data collection field that should be on the CRF (e.g., a regulatory
requirement (if applicable)). (e.g. Adverse Event Term)
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Recommended/Conditional
A data collection field that should be collected on the CRF for specific cases
(may be recorded elsewhere in the CRF or from other data collection
sources). (e.g. AE Start Time)
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Optional
A data collection field that is available for use if needed. (e.g. Were there
any AE Experienced?)
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CDASH Domain – New Ideas
Physical Examination (PE)
•Use PE form to record only whether
or not exam was done
•Instruct Sites to record,
–Baseline Abn.: MH, Targeted MH
or Baseline Conditions CRFs.
–Post baseline abn. or baseline
conditions that worsened on AE
CRF
Inclusion/Exclusion (IE)
 Use IE form to collect only the
criterion or criteria NOT MET for
Inclusion/Exclusion criteria
CDASH Domain – New Ideas
Protocol Deviations (DV)
Avoid creating a protocol
Deviations CRF because this
information can often be derived
from other CRF domains or
system functionalities.
Comments (CO)
Avoid the creation of a General
Comments CRF which collects
unsolicited comments.
“Practical Implementation of Clinical Data
Acquisition Standards (CDASH) in the
CDISC Operational Data Model”
Mark Wheeldon, CEO, Formedix
Bay Area User Group, 29th May, 2008
Who are we?
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Involved with Standards since 2001
All our solutions are based on Open CDISC Standards
CDISC Products and Consultancy Company
– Planning, Preparation and Implementation CDISC Services
– Products so you can use CDISC in house!
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Product Focus is on Study Specification and Design Tools
– Origin™ authoring tools to streamline Protocol to Submission Process
– Database Specification uses CDISC Operational Data Model
• Origin Study Modeller™
– Submission Specification uses CDISC Define.xml
• Origin Submission Modeller™
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Must work with and around existing processes/technologies
– Operational Data Model for EDC auto generation
– Existing internal analysis and reporting structures
– New or existing extract, transfer and load tools
How could CDASH be used
today?
• Use as a Content Standard
– Off the shelf Case Report Form content
– Describes relationship between Operational Data and
Submission Datasets
– CDASH represented within a proprietary file format
• Excel, Word, Proprietary EDC system format
• Potentially unstructured
• Use within Machine Readable Metadata
– CDASH represented in CDISC Operational Data Model
– Vendor neutral system independent format
– Hierarchical structure is ideal for re-usable library of
Components
Benefits of using CDASH within
the CDISC Models
• Library Development
– CDASH forms represented in CDISC Database Standard
– Safety Domains in CDISC Submission Standard
• Study Specification
– Using CDISC metadata to reduce study set-up time
• Automation of Electronic Data Capture Build
– Using CDISC ODM to reduce study build times
• Optimize Downstream Dataflow
– Operational data to submission
– Reduces mapping complexity
– Makes mappings re-usable
What is a CDASH-ODM Form
Composed Of?
CDASH Content
Clinical Context
Study Data
Tabulation Model
Submission
<ODM>
<Study>
<Meta…
</Meta…
</Study>
</ODM>
Terminology
Codelists
Operational
Data Model
Database Content
and Structure
CDASH - ODM
Form
Presentation
Extended ODM
Best Practice
Modelling
Structure
What is CDASH?
What is it Not?
• Content Standard NOT a Model
– Database Variable Name, 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 is it not?
– One to one mapping with the SDTM
– AEYN not in SDTM
– AEBODSYS not in CDASH
ODM Building Blocks
How does CDASH Relate?
Clinical Database
Variable Name
Controlled Terminology
CDASH CRF
Label/Question
CDASH Core
(Highly Recommended)
CDASH Adverse Event Form in ODM
No more hand building of this…
A Dedicated Authoring Environment for Each
Standard…
Origin Study Modeller™
Origin Submission Modeller™
Role Centric Visualizations –
Clinician’s eCRF
Role Centric Visualizations –
Data Manager’s Tabular Specification
Multi-Vendor Visualizations –
PhaseForward
Multi-Vendor Visualizations - Medidata
Multi-Vendor Visualizations - Paper
Optimal Solution from Standardized
Content to any EDC System
CDASH Content
Extended
ODM
Study Design
In ODM
System A
Therapeutic
Specific
Content
Internal
Data Standards
<ODM>
<Study>
<Meta…
</Meta…
</Study>
</ODM>
Vendor Neutral
Portable
Format
+
System B
Proprietary
System
Features
Controlled
Terminology
Codelists
System C
Optimizing Downstream Dataflows
CDASH vs. Non CDASH Form Differences
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Optimizing Downstream Dataflows
CDASH vs Non CDASH SDTM Differences
CDASH
Non-CDASH
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Conclusions
CDASH-ODM Delivers Today
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Library Development
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CDASH brings clinical perspective
CDASH links to SDTM to bring a submission perspective
Quickly settle disputes over content
Streamline Study Set-up and EDC Build Process
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Eliminate manual study specification
Study Spec from 492 hrs down to 158 hrs (3x shorter)
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30-40% build time reductions
Downstream Raw Data to Submission Dataflow Optimisation
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Consistency between Operational Data and Submitted Datasets
Reduction in mapping complexity – quick to create
Mappings easier to maintain
CDASH Goals
• Finalize and Post CDASH final draft for public
review
• CDASH Roadshow & Training program.
• Finalize and Post CDASH V. 1.0 on CDISC.org.
• Develop and Publish CDASH-ODM metadata
– Establish subgroup, Scope, Deliverables, Participants
and Timelines
• Identify and Collect feedback from “Early
Implementers”
• “CDASH” New SDTM Domains as required.
Strength through collaboration.
PLEASE VOLUNTEER!!!
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