Transcript Standardized CRFs – Increasing Site Compliance and

CDISC Bay Area Users Group Meeting
CDASH Status Update
July 13, 2009
Dorothy B. Dorotheo
InterMune
CDISC©2009
CDASH Status Update
• CDASH Project Background and Overview
• CDASH-ODM: A “Starter Kit” of Machine-Readable
Basic CRF Elements
• CDASH Version Updates & User Guideline status
• CDASH Focus for 2009
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Project Snapshot
 Streamlines data collection at
investigative sites - addresses
Critical Path Opportunity #45
 Continuation of ACRO’s
Initiative
 Started October 2006
 Supported by a collaborative
group of 17 organizations
 Core team of 16 members
manages..
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11 working groups
Comprised of between 8-40
volunteers
 ~190 working group volunteers
 16 Safety data domains
developed
 Consolidated document posted
for public review in May 2008
 Received over 1800 comments
from 46 companies, institutions
and agencies.
 All 3 ICH regions were
represented in the public
comment process
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US
Europe
Japan
 CDASH V1.0 published
October 2008
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Participants
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
Participants in the CDASH Initiative
Other = academic research organizations,
government (NIH, NCI), hospitals, universities
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CDASH Purpose & Scope
 Develop content standards for a basic set of global
industry-wide CRF fields to support clinical research
 element name
 definition
 metadata
 Initial scope limited to most commonly collected data
 These CRF standards apply across all therapeutic areas
and phases of clinical development (I-IV)
 Follow CDISC defined standards development process.
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CDASH Development Steps
 Started with regulatory electronic study
submission standard - Study Data Tabulation
Model (SDTM)
 Focused on CRF Content, not CRF Layout
 Collected > 150 CRF samples across industry
 Evaluated commonalities/differences between
CRF samples
 Documented data points included/excluded with
justifications
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CDASH Development Steps
(Continued)
• Agreed on basic CRF collection fields
• Mapped to SDTM
• Defined required terminology with the CDISC
Terminology Team
• Developed CRF question definitions and
completion instructions for clinical sites and
sponsors
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CDASH Version 1.0
Published
October 2008
Clinical Data Acquisition Standards
Harmonization:
Basic Data Collection Fields for Case Report
Forms
Prepared by the CDISC CDASH Core and Domain Teams
Revision History
Date
2008-08-22
Version
Final Draft 1.0
Summary of Changes
NA
Available for download at:
http://www.cdisc.org/standards/cdash/index.html
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How can 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 several file format
• Excel, Word, Proprietary EDC system format
• Potentially unstructured
• Use within Machine-Readable Metadata
– CDASH represented in CDISC Operational Data Model (ODM)
– Vendor neutral system with an independent format
– Hierarchical structure is ideal for re-usable library of components
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Implementation to Date
• Adopted by industry, eVendors and other
organizations.
• Utilized as a platform/template to support efforts
around electronic health records (IHE & HITSPI
efforts)
• Harmonized with NCI’s caBIG project.
(CDASH basic fields + Oncology fields = standard CRF in
the oncology workspace)
CDASH has and will continue to facilitate many
positive changes on how clinical data can be
collected.
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CDASH-ODM: A “Starter Kit” of
Machine-Readable Basic CRF
Elements
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CDASH-ODM Initiative:
Started May 2008
• Participating Companies
– InterMune, Formedix, Quintiles, Shire, Schwartz Pharma,
Outcome, AstraZeneca, eLilly, Medidata, ERT, XClinical, IPL,
Octagon Solutions, CDISC, Cerner, Greenway, PRA Intl., GSK,
Forrest Laboratories, Genzyme - ODM/Core
• Initial Scope: CDASH DOMAINS
– AE, Prior & Concomitant Meds, Demography, Common
Identifiers.
• Initial Deliverables: March 2009
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Metadata tables
CRF representations
CRF with database annotations and CDASH alias
ODM files
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CDASH Delivers Content
NOT CRF Layout
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Data Collection
Field
Basic data to
be collected..
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Variable Name
(CDASH variable
name shaded)
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Definition
Case Report
Form
Completion
Instructions
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Additional
Information for
Sponsors
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CDASH Core
How to
Describes the
implement
purpose of the
the CRF
data collection
data collection
field
SDTM-IG based
variable
variable name
CRF
CDASH
(CDASH)
Completion
Core
(Variable name
Instructions
Designations
shaded)
for Sites
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A CDASH-ODM Form Contains:
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
Best Practice
Modelling
Presentation
Extended ODM
Structure
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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
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CDASH-ODM –
AE Form in ODM
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CDASH-ODM – AE (Paper)
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CDASH-ODM – AE Form (EDC)
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CDASH-ODM –
DM Form in ODM
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CDASH-ODM – DM (paper)
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CDASH-ODM – DM (EDC)
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CDASH-ODM –
CM Form in ODM
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CDASH-ODM –
CM FORM (Paper)
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CDASH-ODM –
CM FORM (EDC)
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CDASH ODM
Domains
Set-1
Set-1
ODM &
CRFs
CDASHODM
Set-2
ODM &
CRFs
Set-3
ODM &
CRFs
Status
Adverse Events
March 2009 - Done
Prior & Concomitant Medication
Demographics
Common Id & Timing Variables
Set-2
Vital Signs
Started …Ongoing
Medical History
Substance Use
ECG scenario 1
Lab scenario 1
ECG scenario 2
Lab scenario 2
ECG scenario 3
Lab scenario 3
Subject Characteristic
Set-3
Inclusion and Exclusion Criteria (IE)
To start in August 2009
Comments (CO)
Disposition (DS)
Drug Accountability (DA)
Exposure (EX)
Protocol Deviations (DV)
Physical Examination (PE)
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CDASH Version Updates
&
User Guideline status
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CDASH Program Plan 2009-2010
CDASHODM
CDASH
DEVICE
Set-1
ODM &
CRFs
Set-2
ODM &
CRFs
Set-3
ODM &
CRFs
Properties
Accountability
Malfunction
CDASH
V 1.1
Correction
/Additions
CDASH
CDASH
ODM
CRFs
User Guide
V 1.0
Q4
09
Device
domains
ICVs Q409
CDASH-ODM
CDASH V 1.1
CDASHUG
1.0
Released
Q2 10
CDASHODM
CDASH-ODM
CDASH V 1.1
CDASHUG 1.0
Q2
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CDISC CONSENSUS PROCESS
Initial
Consensus
Version (ICV)
TLC Review
Harmonized
Version (HV)
External
Focused
Review
Reviewed
Version (RV)
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Public
Review
Released
(Production)
Version 1.0
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CDASH Projects–
Why are we doing this???
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Eliminate some of the variety in CRFs
Streamline training & support common understanding
Reinforce collecting only key data
Reduce collection of duplicate data - decreasing the
potential for error
Minimize data queries
Facilitates populating CRFs by eHR without re-entry
(Cuts down on study start time – for all stakeholders)
Better quality of collected data
Facilitates efficient mapping to SDTM for CDASH
implementers
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Draft CDASH User (UG)
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CDASH USER GUIDE - TOC
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CDASH UG -- TOC
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CDASH UG -- TOC
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CDASH UG -- TOC
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CDASH UG -- TOC
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CDASH DEVICE Domains
CDASH
DEVICE
Properties
Accountability
Malfunction
•3 additional domains to be added to CDASH V 1.1 for DEVICES
•SDTM & CDASH are being developed at the same time
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CDASH Focus for 2009
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Focus 2009
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Develop CDASH Training Program
Collect feedback from “Early Implementers”
Update CDASH v. 1.0 to 1.1
Develop and Publish Machine Readable Metadata
(CDASH ODM)
• Develop basic data collection fields for Devices
• Develop the CDASH-User Guide (CDASH-UG)
• Present, publish and train the CDASH standard at all
appropriate venues
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Thanks to all the volunteers who have
worked to get us where we are today!
Comments and suggestions for improvement of
the CDASH standard and CDASH ODM products
are welcome.
Contact:
[email protected]
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