Strategic Goals

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Strategic Goals

• Clinical Trials Management Systems

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Timeline of Strategic Goals Clinical Trials
Management Systems
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Timeline of Strategic GoalsClinical Trials
Management Systems
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Timeline of Strategic GoalsStructured Protocol
Representation

• Year 1 End of 2005
• UML model of caPSR V1 (CDISC-based) for initial
  entry/tracking of trial, support for SOWs
  (adopters developers), priorities use cases
  for extensions
• Year 3 Summer 2008
• Deploy caPRI for CT registry, patient
  eligibility, patient registration, Tx calendar,
  CRFs, Summary 4, etc.
• Year 5 Summer 2010
• Complete PI authoring, custom report generation,
  data mining, results repository, and statistical
  analysis components

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Timeline of Strategic GoalsVocabulary / Metadata

• Year 1 End of 2005
• Establish process propose table for 1200 core
  CT data elements to be created in ISO 11179
  standards
• Year 3 Summer 2008
• Continue to support CTMS needs for ISO 11179 data
  elements develop tool to enhance caDSR user
  interface
• Year 5 Summer 2010
• Continue to support ISO 11179 compliance
  recommend methods to enhance user training

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Timeline of Strategic GoalsAdverse Events
Reporting

• Year 1 End of 2005
• caBIG functional alpha prototype for AE Modules
  1-4 deployed and tested at adopter sites
• Year 3 Summer 2008
• All 12 modules in place, with interfaces to
  vendors and agencies
• Year 5 Summer 2010
• Work with NCI, FDA, pharma to develop deploy AE
  data mining tools and public access
  policies/procedures

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Timeline of Strategic GoalsLaboratory Interfaces

• Year 1 End of 2005
• caBIG lab interface SOW based on use cases, lab
  survey (interface to AE SIG, screening,
  reporting)
• Year 3 Summer 2008
• HL7 V3 messages to transfer data from 2 vendors
  and into CT databases
• Year 5 Summer 2010
• De-identified lab data in the Grid, Toolkit
  developed to transfer any lab data

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Timeline of Strategic GoalsCTMS/CDUS Reporting

• Year 1 End of 2005
• White paper on enhanced reporting functionality
  to improve CTEP reporting process interface with
  AE SIG
• Year 3 Summer 2008
• caBIG module for CTMS/ CDUS reporting, AE
  denominator data
• Year 5 Summer 2010
• Further harmonization of reporting with
  FDA/CTEP/pharma

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Timeline of Strategic GoalsFinancial/Billing

• Year 1 End of 2005
• Use cases, data elements, glossary, functional
  requirements via questionnaire to develop SOW
  with focus on Trial Financial Ledger
• Year 3 Summer 2008
• Execute SOW to test, document, deploy software to
  users
• Year 5 Summer 2010
• Further enhancements, training on financial
  modules

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Timeline of Strategic GoalscaBIG Compatibility

• Year 1 End of 2005
• Evaluation of caBIG guidelines, conduct gap
  analysis leading to v1 procedure to evaluate
  CTMS caBIG compatibility
• Year 3 Summer 2008
• v2 procedure for evaluation of caBIG
  compatibility as guidelines emerge from
  cross-cutting workspaces
• Year 5 Summer 2010
• vX procedure for evaluation of caBIG
  compatibility as guidelines emerge from
  cross-cutting workspaces

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Kickoff Prioritized Short List

• Adverse Event Reporting
• Interfaces to Lab Systems
• CDUS/Theradex/CTEP Reporting
• Financial/Billing
• Structured Protocol Representation
• caBIG Compatibility
• CDEs / Metadata

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Kickoff Addl Requirements

• Multiple Inputs
• Web Interface, Database Access
• Legacy data integration
• Interoperability with multiple heterogeneous data
  sources
• Middleware layer - interaction between components
  data sources/targets, caBIG interface engine
• Regulatory
• Outcomes assessment

• Automatic grading of toxicities for CTC
  (quantitative and qualitative)
• Data conversion tools
• Patient eligibility filtering/tracking
• Matching patients to clinical trials
• Systematic lay summaries
• Investigator Registry
• Summary 4 reporting
• Regulatory reporting
• Support multiple destination formats for
  reporting
• FDA, CTEP, IND, Holder, hospitals

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Kickoff Survey Items

• 1. Protocol Authoring
• 2. Protocol Registration
• 3. Protocol Abstraction
• 4. Protocol Status Tracking
• 5. Data Forms Expectations
• 6. Physical Protocol Doc Mngmt
• 7. Electronic Protocol Doc Mngmt
• 8. Protocol Workload Assessment
• 9. Patient Eligibility Filter
• 10. Central Patient Registration
• 11. Protocol Tx Assignment

• 12. Study Participant Doc Mngmt
• 13. Toxicity Monitoring
• 14. Treatment Monitoring
• 15. Interim Analysis Notification
• 16. Outcomes Assessment
• 17. Protocol Conduct Monitoring
• 18. Regulatory Monitor/Report
• 19. Financial/Billing
• 20. Patient Scheduling
• 21. Adverse Event

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Workspace Prioritization Matrix