System Interoperability and Harmonization (SIH) SIG: Why, What, How and When?

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System Interoperability and Harmonization
(SIH)SIGWhy, What, How and When?

• Peter Covitz, Ph.D.
• NCICB Project Manager
• Charlie Mead, M.D., M.Sc.
• Booz Allen SIH SIG Support Lead

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Agenda

• Welcome Introductions
• SIH Background Information (Why?)
• SIH Goals Objectives (What?)
• SIH SIG Model of Operations (How?)
• SIH Development Time Line (When?)

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Agenda

• Welcome Introductions
• SIH Background Information (Why?)
• SIH Goals Objectives (What?)
• SIH SIG Model of Operations (How?)
• SIH Development Time Line (When?)

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Background Information (Why?)CTWG
Restructuring the National Cancer Clinical Trials
Enterprise

• CTWG Vision Statement
• Enhance the best of all the components of the
  NCI-supported clinical trials system to develop a
  cooperative enterprise built on a strong
  scientific infrastructure and a broadly engaged
  coalition of critical stakeholders.

CTWG Report http//integratedtrials.nci.nih.gov/i
ct/CTWG_report_June2005.pdf
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Background Information (Why?)CTWG
Restructuring the National Cancer Clinical Trials
Enterprise

• Report issued in June 2005
• How to realize the promise of molecular medicine
• 22 recommendations designed to support an
  efficient transparent clinical trials
  enterprise
• integrates the individually strong components of
  the current system into a cross-disciplinary,
  scientifically driven, and cooperative research
  effort.

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Four CTWG Informatics-based Initiatives (Why?)

• Establish a Comprehensive Community-Accessible
  NCI Clinical Trial Database
• Promote System Harmonization Interoperability
  between NCI Clinical Trials systems
• Establish a Core Library of Standardized
  Case Report Forms (CRFs) through
  Stakeholder Consensus
• Develop a Credentialing System for Investigators
  and Sites

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Agenda

• Welcome Introductions
• SIH Background Information (Why?)
• SIH Goals Objectives (What?)
• SIH SIG Model of Operations (How?)
• SIH Development Time Line (When?)

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Goals and Objectives (What?)
Promote establishment of national clinical trial
information technology infrastructures that are
fully interoperable with NCIs cancer
Bioinformatics Grid CTWG Report, June 2005
Goals Objectives
Harmonization and caBIG compliance of internal and external NCI clinical trials IT systems NCI internal and external IT systems to share and exchange research data, information and knowledge Enable secure and transparent NCI community access to clinical trials research data Establish agreed upon interchange standards and interfaces to achieve interoperability Minimize reporting requirement burdens for site investigators
Web access to site and investigator tools Enable protocol initiation activities Provide a portal to support Clinical Trial Research activities through the lifecycle
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Agenda

• Welcome Introductions
• SIH Background Information (Why?)
• SIH Goals Objectives (What?)
• SIH SIG Operational Model (How?)
• SIH Development Time Line (When?)

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Operational Model (How?)

• Build upon the caBIG Foundation
• To create -- in partnership with the extramural
  community -- a national cancer clinical trials
  information technology infrastructure fully
  interoperable with NCIs cancer Biomedical
  Informatics Grid (caBIG) to improve the cost
  effectiveness and comparability of results across
  all NCI trials.

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Operational Model (How?)

• The caBIG CTMS Workspace will
• Support broader CTMS Workspace participation to
  include
• Cooperative groups, CCOPs, SPORES, NCI intramural
  and extramural stakeholders and other stakeholder
  organizations
• Practitioners (Principal Investigators, research
  nurses, clinical trial monitors, statisticians
  and other end-user stakeholders)
• Deliver on the four informatics-based
  recommendations highlighted in the CTWG Report

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SIH SIG Operational Model (How?) Focus on Risk,
Relevance, and Quality
Lifecycle I
Lifecycle II
Construction Phase
Transition Phase
Inception Phase
Elaboration Phase
Inception Phase
Structured Risk Management
Vision and Scope
Refine Vision and Scope
Multi-disciplinary Workflow
Develop System Inventory Methodology
Apply System Inventory Methodology
Plan Harmonization Effort
Document Process and Data Flow in both worlds
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SIH SIG Project Management (How?)Structured Risk
Management
Risk Date Type Lkhd () Impact Mitigation Plan
xxxxx dd/ mm/ yy Requirements 50 moderate 1. _at_ 2. ! 3.
yyyyy dd/ mm/ yy Technology 60 severe 1. 1. _at_ 2. ! 3.
zzzzz dd/ mm/ yy Resources 90 severe 1. _at_ 2. ! 3.
www dd/ mm/ yy Political/ Cultural 100 fatal 1. _at_ 2. ! 3.
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Preventing Requirements Drift (How?)

• Vision and Scope document
• System inventory
• Internal
• External
• ? Definitions ?
• Clinical Trial Business Model
• Today (as is)
• Tomorrow (could/should be)
• Delta

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Agenda

• Welcome Introductions
• SIH Background Information (Why?)
• SIH Goals Objectives (What?)
• SIH SIG Model of Operations (How?)
• SIH Development Time Line (When?)

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SIH 2006 Timeline Lifecycle I (When?)
Informational Sessions
Launch CTDB, CRF, SIH SIGs
Lifecycle II
Lifecycle I
Oct - ???
May
June
July
August
September
Vision and Scope document (version 1.1)
Instantiate Governance
Begin to develop system maturity tool
Begin to develop Clinical Trial Business model
(static and dynamic)
Vision and scope document (version 1)