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CDISC Implementation Strategies: Lessons Learned & Future Directions . MBC Biostats & Data Management Committee 12 March 2008 Kathleen Greene & A. Brooke Hinkson, BioMedical Operations, Genzyme Corporation. Agenda.

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cdisc implementation strategies lessons learned future directions

CDISC Implementation Strategies: Lessons Learned & Future Directions

MBC Biostats & Data Management Committee

12 March 2008

Kathleen Greene & A. Brooke Hinkson,

BioMedical Operations, Genzyme Corporation

  • Take you on a journey through time to reflect on Genzyme’s CDISC implementation strategies
  • We will travel
    • Back in time to “The Past”
    • Through “The Present”
    • Into “The Future”
  • Questions & Comments
introduction to sdtm
Introduction to SDTM
  • Submissions
    • Outsourced end stage SDTM conversion submitted to FDA
  • Data Operations
    • Submission Datasets: SDTM-like datasets
      • Create SDTM-like datasets from raw EDC data
    • Data collection: Define new CRF standards
      • Incorporate SDTM variables into eCRFs
july 2005 first sdtm submission
July 2005 First SDTM Submission
  • Motive: Desire to comply with eCTD Guidance
  • Timeline: September 04 – April 2005
    • Provided listing CRTs and SDTM datasets to FDA
    • SDTM datasets & define.xml never used by FDA reviewers
  • Outsourced:
    • Performed end-stage conversion (mapping & creation of SDTM datasets)
    • Created define.xml & annotated CRFs
  • Scope: 41 domains; 28 SUPPQUALS
submissions lessons learned
Submissions Lessons Learned
  • First SDTM submission effort required significant amount of unanticipated Genzyme effort
  • Valuable lessons regarding implementing SDTM
      • Detailed knowledge of the study data
        • Mapping exercise required cross functional team
      • Interpretation of standard
        • There are implementation choices; no universal way all companies should implement SDTM
      • Implementation standards
        • Genzyme needs to create implementation standards and governance of the standards
sdtm flight attempts
SDTM Flight Attempts
  • Submission datasets:
    • Create SDTM-like datasets from raw EDC data
  • Data collection:
  • Define new CRF standards
    • Incorporate SDTM variables into CRFs
why attempts fizzled
Why Attempts Fizzled


  • Initiative must be cross-functional
    • Change cannot be made in isolation; must have up and downstream agreement on new processes and deliverables
  • Did not have infrastructure to work with fully compliant SDTM datasets
    • Conflicts with project timelines

Data Collection

  • Competing with other initiatives
    • New version of Clintrial, EDC implementations, M&A’s
  • Push submission requirements upstream
odm experiences
ODM Experiences
  • Electronic Submissions
    • define.xml: submit case report tabulation metadata to FDA
  • Metadata Driven Study Authoring
    • Begin establishing libraries of proprietary and non-proprietary eCRFs
    • Create vendor extensions to ODM
      • Generate visualizations that mirror EDCvendor’s application user interface & functionality
      • Import Genzyme defined ODM into vendorstudy architect tools
odm lessons learned
ODM Lessons Learned

Metadata Driven Study Authoring

  • Make decisions regarding horizontal/vertical specifications
  • Successfully exchange study metadata (forms and workflow) with EDC vendors
  • Need infrastructure to successfully utilize tool
    • Limited reusability of individual study CRF builds across programs
    • Not just anyone should define studies using the tool
      • Study modeler should have strong understanding of database design and CDISC SDTM & ODM
present environment
Present Environment

Caption: The scaffolding took longer to assemble than the rocket

may 2007 second sdtm submission
May 2007 Second SDTM Submission
  • Motive: FDA requested SDTM for all domains
    • Jan 07 negotiated DM, AE & all SUPPQUALS
  • Timeline: October 2006 – March 2007
    • Provided listing CRTs, CSR and CRFs to FDA in March
    • May provided DM, AE, SUPPQUALS, define.xml and annotated CRFs
      • Descriptive documentation of our mapping process
    • SDTM datasets and define.xml were used by FDA medical reviewer for safety review
  • Outsourced:
    • Performed end stage conversion (mapping & creation of SDTM datasets)
    • Created define.xml
  • Scope: 2 domains & 2 SUPPQUALS
lessons learned
Lessons Learned
  • FDA requesting SDTM now!!
  • Applied lessons learned from 1st experience to 2nd project
    • Weekly cross-functional meeting with vendor
  • Output failed WebSDM validation
    • Validation failures identified at Genzyme
    • We need to incorporate our submission requirements upstream in data collection
  • Not efficient implementation strategy to convert data to SDTM so late in the clinical data lifecycle
    • Creating extra work for stat. programming, stats. and esub
  • End stage conversion is expensive!!
cdisc roadmap purpose
CDISC Roadmap Purpose
  • To present a clear and complete picture of:
    • Where CDISC standards fit into the entire clinical data lifecycle
    • What activities must occur to integrate the standards into the processes and sub-processes within each lifecycle stage
  • Provide a common language and reference for further dialog, planning, design, and implementation of CDISC Standards.
series of initiatives build a complete cdisc standards implementation
Series of Initiatives Build a Complete CDISC Standards Implementation

Data Flow #1: Late-Stage Conversion

Provide SDTM data to FDA

Submit (as SDTM) the collected data on which analysis is based

Data Flow #2: Mid-Stage Conversion

Data Flow #3: Standards in Collection,Processing & Storage

Collect, process & store data according to standards

Extend standards-based metadata-driven data flow further upstream into trial design

Data Flow #4: CDISC Standards inin Trial Design

data flow strategy
Data Flow Strategy
  • Meet regulatory current requests and soon-to-be requirements as soon as possible
  • Integrate CDISC standards more broadly and deeply into business processes
    • Develop clinical data based upon CDISC standards instead of converting the data to CDISC standards
    • Fully gain operational efficiencies from the use of standards
metadata repository
Metadata Repository
  • Currently being defined
  • Manage data about the data
  • Serves as a central hub for automation of upstream and downstream processes and tools
    • i.e. protocol & CRF development, SAS TLF programming
  • Enforces standards
  • Improves efficiency of process flow
  • Enables reusability
data standards team governance
Data Standards Team & Governance
  • Data Standards Team is essential to successfully implement CDISC standards
  • Data Standards Team will develop, implement, maintain, educate, communicate and govern the standards globally
    • Standards cannot be viewed as optional
  • Implementation of data standards includes process changes, technology modifications and more subject matter expertise
triage team charter
Triage Team Charter
  • An interim committee to provide guidance and support to a select number of studies for mapping & programming SDTM datasets
    • Focus on end & mid-stage conversion activities
    • Will not be involved with attempts to implement standards at the protocol, CRF or database design lifecycle phases
    • Will be replaced by the global cross-functional governance body implemented as part of CDISC Roadmap Project
triage initiative
Triage Initiative

*Include Clinical, Coding, IT & RA as needed

  • Initiative began Q4 07 will go through 2008
  • Completed 2 reviews so far
  • Anticipate conducting 10 reviews in Q2 & Q3, with additional studies to be determined in Q4
  • Currently considering expanding scope to include review of CRF and database design
triage lessons learned
Triage Lessons Learned
  • Process works!
    • Highlights importance of cross-functional communication
  • Need additional cross-functional resources to support initiative
  • Need to operationalize training for new projects going through triage reviews
  • Implementation questions: obtain outside guidance, when needed
parallel efforts converge

Phase III: Implementation

Phase II: Design Phase

Triage Review

CRF Standards


Parallel Efforts Converge

Phase I: CDISC Roadmap

participation in standards activities
Participation in Standards Activities
  • SDTM Device Sub Team
  • ADaM Working Group
  • WebSDM User Group
  • FDA ODM Pilot
  • HL7 (Q2 2008)
  • CDISC User Networks (BACUN)
future environment
Future Environment
  • Visions is evolving
  • Established standards and governance
  • Adoption of a growing list of commercially available standards based products
  • Process improvements enabled by technological advances
  • Technological and operational infrastructure to support a metadata driven end-to-end clinical data lifecycle
sample future capabilities
Sample Future Capabilities
  • Ability to collect, store, analyze/report, compile/submit data to FDA according to SDTM, in conjunction with other CDISC standards
  • Ability to integrate other, non-CDISC, standards
  • ODM XML based interchanges of clinical data with vendors (i.e. EDC vendors, labs, FDA, etc.)
  • Metadata based protocol writing tools that establish the framework for collection, analysis & reporting at the inception of the study design