Joyce C' Niland, PhD

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CTMS WorkspaceAdverse Event SIG Update
January 30, 2006
Joyce C. Niland, PhD Abdul-Malik Shakir Hemant
Shah, MD City of Hope
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Adverse Event SIG Update

• Overview
• caAERS Project Status (J. Niland)
• Evolution of the caAERS Model (AMS)
• Metadata Project / caAERS CDEs (H. Shah)
• Lessons Learned to Date (J. Niland)
• AE SIG Goals for 2006 (AE SIG)
• Summary 3 / 4 Reporting Tool (RDX SIG)

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Adverse Event SIG Update

• caAERS Project Status

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AE SIG Activities to Date

• Develop a vision for caAERS (12 modules)
• Establish highest priorities
• Gather user requirements identify issues
• Create static and dynamic models
• Initial system design and prototyping

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Componentized Approach to caAERS
Clinical Trial Participants
IRB
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Componentized Approach to caAERS
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Public SafetyProfiling Website
CTC RelatedLab Data
CTC RelatedQualitative Data
Clinical Trial Participants
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Safety Profiler
Grade 1- 5 AEs
Automated CTC Grading
caBIG Adverse Event System (AES)
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AE Data
Patient/Protocol Data
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Transmission to External Agencies
Internal Routingand Review
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Publication of Summary Results
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IRB
PI/CRA
PatientSelf-Reporting
DSMB Monitor
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Data Mining forRisk Patterns
Transmission to caBIG AE Data Warehouse
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Interviews and Collaboration

• As issues emerged, entered into an Issues Log and
  distributed to SIG members for discussion

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Use Cases, Business Diagrams, and Detailed Use
Cases
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Use Case-Driven Data Dictionary

• Serves as the caAERS data dictionary
• Provides mapping among the varied
  representations
• Data elements derived and reconciled via use
  cases
• Maintained as an Access database
• Provides customized views by reporting agency
• Feasible for terminology management

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Vetting with the AE SIG

• 15 AE SIG calls in 2005
• 13 CTMS Working Group calls
• Visits to Mayo, Pittsburgh and UCI
• Teleconferences with Wake Forest, Mayo, Yale,
  CTEP, and DCP

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Thank You!

• To All SIG Participants
• With special thanks to the following SIG members
  and their fellow staff members

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Vetting of Data Flow Scenarios with AE SIG
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Process for Creating AE

• AE request initiated from local CTMS(includes
  protocol and study participant data)
• In caAERS, user presented with Active AEs--
  new skeletal AEs-- incomplete AE entries--
  AEs requiring expedited reporting
• User enters core AE data to establish if its a
  duplicate (previous entries displayed)

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Process for Creating AE (2)

• User enters baseline AE data system determines
  reporting requirements
• If expedited reporting required, extended data
  entered and related AEs identified for report
• Incomplete entries can be saved and are displayed
  on Active AE list until completed
• Expedited Report generated and available as PDF
  and XML Message

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Conceptual Data Model (CDM)
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Expert HL7 Modeling Consultant
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Adverse Event SIG Update

• Evolution of the caAERS Model

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Adverse Event SIG Update

• Metadata Project / caAERS CDEs

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Adverse Event SIG Update

• Lessons Learned to Date

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caBIG Adverse Events Reporting System (caAERS)
Prototype Architecture
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Lessons Learned

• caAERS is a much more complex model than those
  run through the caCORE SDK tools previously
• SDK Code generation tools do not handle complex
  data types, abstract classes needed to flatten
  the model to utilize tools
• To meet caDSR constraints, data types need to
  resolve to Java primitives
• Tools generate read-only APIs, limited
  functionality with regard to generating secure
  writable APIs
• Common Security Model (CSM) tool currently not 21
  CFR Part 11 compliant building security module
  for caAERS
• caFramework tools provide for development of
  basic forms, may not meet the best practices for
  caBIG GUIs
• Harmonization with BRIDG, ICSR, etc is critical,
  first session to be held soon

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Harmonization Process of Subcomponents of the
BRIDG Model
caAERS
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Adverse Event SIG Update

• AE SIG Goals for 2006

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AE SIG Goals for 2006

• Proposed Goals for Discussion
• Complete caAERS prototype - April 2006
• Work with caAERS adopters to develop test plans
  and deploy/evaluate prototype

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• Creating a software system without delivering
  anything to the users until everything is done,
  is like constructing a complete office building
  on its side, then trying to lift it into
  position.

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AE SIG Goals for 2006

• Proposed Goals for Discussion
• Complete caAERS prototype - April 2006
• Work with caAERS adopters to develop test plans
  and deploy/evaluate prototype
• Work with CTMS WS, Architecture SIG, and other
  SIGs to identify an open source workflow engine
• Build caAERS V2 Modules 1-4 (CSM, configurable
  rules/triggers for reporting, all agencies)
• Requirements gathering, design, and build of CTC
  Automation Tool for lab data (Module 8)
• Other ideas / suggestions?

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Questions?