touch points – imaging and the bam imaging face to face may 10, 2010 michele ehlman contractor,...
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Touch Points – Imaging and the BAM
Imaging Face to FaceMay 10, 2010
Michele EhlmanContractor, Center for Biomedical Informatics
and Information TechnologyEssex Management
Imaging Face to FaceMay 10, 2010
Michele Ehlman
Contractor, Center for Biomedical Informatics and Information Technology
Essex Management
Touch Points – Imaging and the BAM
1
Agenda - Overview
• Welcome
• caBIG and Lego
• What is the Business Architecture Model
• Imaging/BAM – Current touch points
• Questions
• Thank- you
LEGOLAND IMAGE
But did you know?
The key points…
• One of the key features of Lego bricks throughout their history is that they are, first and foremost, part of a system.
• Each new series and set that is released is compatible with the rest of the system; Lego pieces regardless of their size, shape or function, fit together with all other Lego pieces in some way.
Lots of different types of models…using different types of bricks…
Processes and Tools that will us to get us there
• Semantic Service Oriented Architecture (sSOA)• Provide Business Models to identify and support
business processes, requirements and interoperability• Scenarios
• Business Use Cases
• Workflows/Activity Diagrams
• Domain Models
• Enterprise Conformance and Compliance Framework (ECCF)
Which will allows us to accomplish our Bench to Bedside and Back goal
The BAM
BAM
A Translational Medicine Business Architecture Model (BAM)
"A blueprint of the enterprise that provides a common understanding of the organization and is used to align strategic objectives and tactical demands."Object Management Group, Business Architecture Working Group, Definition
The Translational Medicine Business Architecture Model (BAM) is a blueprint of translational medicine. It documents a common understanding of the information, “what, who, how, where and when,” necessary to realize research, so that it is accessible to someone, who is not directly involved in research to align strategic objectives and meet tactical demands - providing a communications platform.
Components of the Translational Medicine BAM
Scenarios
A scientist is trying to identify a new genetic biomarker for HER2/neu negative stage I breast cancer patients. Using a caGRID-aware client, the scientist queries for HER2/neu negative tissue specimens of Stage I breast cancer patients
Identify Specimens
Use Cases
Workflow/Activity diagrams
Common Vocabulary(EVS, caDSR & CRFs)
class View SC: Study Conduct
ConcomitantAgent
PerformedActiv ity
+ actualDateRange: IVL<TS.DATETIME>+ actualDuration: PQ.TIME+/ delayDuration: PQ.TIME+ missedIndicator: BL+ missedReason: DSET<SC>+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ comment: ST+ identifier: II+ reasonCode: DSET<CD>
constraints{Is a Function Performed By Qualifier}{actualIndicator Exclusive Or}{Instantiates Exclusive Or}{Occurs in the Context Of Qualifier}{actualDateRange Qualifier}
PerformedProcedure
+ approachAnatomicSiteCode: CD+ methodCode: CD+ targetAnatomicSiteCode: CD+ targetAnatomicSiteConditionCode: CD::PerformedActivity+ actualDateRange: IVL<TS.DATETIME>+ actualDuration: PQ.TIME+/ delayDuration: PQ.TIME+ missedIndicator: BL+ missedReason: DSET<SC>+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ comment: ST+ identifier: II+ reasonCode: DSET<CD>
constraints{Is a Function Performed By Qualifier}
Protocol Representation Sub-Domain::StudyAgent
+ functionCode: CD+ statusCode: CD+ statusDate: TS.DATETIME
Common Sub-Domain::Product
+ classCode: DSET<CD>+ expirationDate: TS.DATE.FULL+ nameCode: CD+ nameModifiedText: ST+ pre1938Indicator: BL+ treatmentVehicleCode: CD+ treatmentVehicleVolume: PQ+ typeCode: CD::Material+ actualIndicator: BL+ description: ST+ effectiveDateRange: IVL<TS.DATETIME>+ formCode: CD+ identifier: DSET<II>+ name: DSET<TN>
constraints{Distributor Qualifier}{Manufacturer Qualifier}{ManufacturingSite Qualifier}
Protocol Representation Sub-Domain::DefinedActiv ity
+ categoryCode: CD+ description: ST+ nameCode: CD+/ repeatDuration: PQ.TIME+ repeatFrequencyCode: CD+ repeatFrequencyRatio: RTO<INT,PQ.TIME>+ repeatQuantity: INT+ statusCode: CD+ statusDate: TS.DATETIME+ subcategoryCode: CD::Activity+ comment: ST+ identifier: II+ reasonCode: DSET<CD>
constraints{actualIndicator Qualifier}{Repeat Frequency Exclusive Or}{Repeat Duration or Quantity Exclusive Or}{categoryCode Qualifier}
ScheduledActiv ity
+ dateRange: IVL<TS.DATETIME>+ duration: PQ.TIME+ rangeOfRepetitionsText: ST+ statusCode: CD+ statusDate: TS.DATETIME::Activity+ comment: ST+ identifier: II+ reasonCode: DSET<CD>
constraints{actualIndicator Exclusive Or}
Protocol Representation Sub-Domain::PlannedActivity
+ blindedDescription: ST+ description: ST+ name: ST+ plannedDuration: PQ.TIME+ purpose: ST+/ repeatDuration: PQ.TIME+ repeatFrequencyCode: CD+ repeatFrequencyRatio: RTO<INT,PQ.TIME>+ repeatQuantity: INT+ targetAccrualNumberRange: URG<INT>::Activity+ comment: ST+ identifier: II+ reasonCode: DSET<CD>
constraints{Repeat Frequency Exclusive Or}{Repeat Duration or Quantity Exclusive Or}{actualIndicator Qualifier}
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uses
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instantiates
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is a functionperformed by
{functions as}1
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uses
{is used during}0..*
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instantiates
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+instantiating
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instantiates
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Scenario (Also known as Enterprise Use Cases, Interoperability Scenarios)
• Paints the picture of an overarching goal to be accomplished and generally captures workflow represented as an outline or manuscript of the projected sequence of events which contains the primary and secondary (or more) goals required to realize the ultimate goal.
• There are two main types Broad Spectrum and Specific.
Use Cases – Business vs. Functional (the amount of information required to make them complete)
Business Use Cases
• Description of the Key goal
• Storyboard
• Actors
• Pre-conditions
• Basic Flow of Events
• Post- conditions
• Notes(Meant to provide the basis for future
functional use cases)
Functional Use Cases
• Description of the goal and the functionality to accomplish
• Storyboard
• Actors• Primary and Secondary (including
system interactions)
• Pre-conditions• Work flow (including alternate flows,
decision points failure conditions…)
• Post- conditions
• Notes
Business Use Case
• A use case is initiated by a user with a particular goal in mind, and completes successfully when that goal is satisfied.
• The Business Architecture Model (BAM) provides a description of the relevant aspects of the business that the enterprise architecture should, by definition, be designed to support. Typically, this will consist of a description and models of key business processes and functions, as well as a description of the organizational structure and environment in which the enterprise operates. 1
• Focuses on the business process and is an easy to understand, conceptual representation of a task or interaction that is captured in a technology-free and implementation-independent description.
1-http://ec2-174-129-196-76.compute-1.amazonaws.com/mediawiki/index.php/5_BIG_HEAS:_Components_of_EAF
Functional Use Case – how they are used
• Describes the sequence of interactions between actors and the system necessary to deliver the service that satisfies the goal. • It also includes possible variants of this sequence, e.g.,
alternative sequences that may also satisfy the goal, as well as sequences that may lead to failure to complete the service because of exceptional behavior, error handling, etc.
• A complete set of use cases specifies all the different ways to use the system, and therefore defines all behavior required of the system, bounding the scope of the system.
Supporting Use Cases (enterprise, organizational, regulatory)
• Use Cases not directly involved with research but are required to support research
• Includes but not limited to:• Procurement process• Permissions• Data management
Workflows and Activity DiagramsNote: In the Unified Modeling Language, activity diagrams can be used to describe the business and operational step-by-step workflows of components in a system.
Workflows• Serves as a visual representation
of step-by-step activities and actions, in logical order, with support for choice, iteration and concurrency required to accomplish a specific goal (use cases)
• Provides basic knowledge so that the goal can be easily communicated and understood.
Activity Diagrams• A graphical representations of
the over all process flow which is made up of multiple workflows (Enterprise Use Cases, Scenarios)
Domain Model (DAM) & Vocabulary
• A Domain Analysis Model (DAM) is an abstract representation of a subject area of interest which is complete enough to allow instantiation of all necessary concrete classes needed to develop specialized, DAM-derived design artifacts. A complete DAM contains a static model (class and instance diagrams) and a dynamic model (activity and occasional state diagrams) PLUS a glossary that unambiguously defines all of the relevant terms used in the two models. The relationship between the static and dynamic models should be consistent, e.g. static structures referenced in process flows should be fully explained in the static model and states named as members of the value set for a statusCode attribute for a given class should be fully defined in the context of a detailed state diagram which describes the life cycle of instances of the class. 2
• a shared view of the dynamic and static semantics for an area of interest. It relates the concepts and objects of the domain to each other
• This model does not include software
• The objects in the domain model are candidates for programming objects
2 - http://ec2-174-129-196-76.compute-1.amazonaws.com/mediawiki/index.php/5_BIG_HEAS:_Components_of_EAF
Translational Medicine Business Model Facilitates…
Function – of a Business Model
• Identify business requirements for software development• Use cases and workflows help developers understand how the
software they are building will be used by the community.• Actors and roles identify who will use the software.
• Assist in defining semantics through alignment with BRIDG and Workspace Specific DAMs
• Identification of common requirements across systems to increase interoperability
• As a training aid for developers and support personnel
Who is using the Translational Medicine BAM?
Currently using the Translational Medicine BAM for requirement identification, development and/or training.
• List of Institutions, Industry and Vendors (Includes but not limited to):
• Duke• Harvard• Mayo Clinic• Columbia• Wake Forest• St. Jude’s• Teradata• Medimmune
Imaging Touch points
Manage Clinical Research
Plan Study touch pointsuc Develop Scientific Plan
Develop Statistical Analysis Plan
Define Objectives
Define Background & Rationale
Develop Eligibility Criteria
Develop Accrual Plan
Describe Study Design and Schema
Define Laboratory Methods to be used for
Ancillary Studies
Describe Patient Recruitment Plan
Define Criteria to Evaluate Response
(Outcomes)
Biostatistician**
Develop Randomization Plan
Develop Protocol and Associated Materials
Define Ancillary Studies
Develop Scientific Plan
Plan Study > Develop Protocol and Associated Materials > Develop Scientific Plan
Plan Study
Study Principal Investigator
Subject Matter Expert*
Patient Advocate
Scientific Collaborator**
Study Team
Institutional Review Board (IRB)**
Funding Sponsor
Define Off -Study Criteria
Released
CTMS/LS Workspace Reviewed
In CTMS/LS Workspace Review
Draft / CTMS/LS Working Group
Placeholder
Legend
Define Measures Define Response Criteria Interpretation Method
Define DICOM Viewer
Define Image Annotation Tool
Define Image Annotation Template
Include Image based Eligibility Criteria
Define Image Methods for Ancillary Studies
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ClinicalTrial«include»
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PopulationScience«include»
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Close-up of the Plan Study Scientific Plan Touch points
uc Develop Scientific Plan
Develop Eligibility Criteria
Define Laboratory Methods to be used for
Ancillary Studies
Define Criteria to Evaluate Response
(Outcomes)
Define Ancillary Studies
Develop Scientific PlanDefine Off -Study
Criteria
Define Measures Define Response Criteria Interpretation Method
Define DICOM Viewer
Define Image Annotation Tool
Define Image Annotation Template
Include Image based Eligibility Criteria
Define Image Methods for Ancillary Studies
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An Outline of Touch Point Use Cases
Define Image Events
uc Develop Operational Plan
Develop Protocol and Associated Materials
Plan Study
Develop Operational Plan
Plan Study > Develop Protocol and Associated Materials > Develop Operational Plan
Define Participant Enrollment Activities
Develop Study/Trial Calendar
Released
CTMS/LS Workspace Reviewed
In CTMS/LS Workspace Review
Draft / CTMS/LS Working Group
Placeholder
Legend
Develop Intervention (Trial) Plan (as
appropriate)
Define Observational Plan (as appropriate)
Define Image Events
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Assess Potential Participating Site Imaging Facility Capabilities
uc Develop Administrative Plan
Identify Required Reports
Identify Auditing Entity
Plan Study > Develop Protocol and Associated Materials > Develop Administrative Plan
Develop Protocol and Associated Materials
Develop Administrative Plan
Plan Study
Identify Participating Sites (Site Identification)
Identify Study/Trial Administrative
Information
Released
CTMS/LS Workspace Reviewed
In CTMS/LS Workspace Review
Draft / CTMS/LS Working Group
Placeholder
Legend
Assess Potential Participating Site Imaging
Facility Capabilities
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Accomplished at Design in POPSCI - usually
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Develop Plan for Response Assessment
uc Develop Study Specific Data and Safety Monitoring Plan
Develop Study Specific Data and Safety Monitoring Plan
Develop Study Specific Plan for the Safety, Monitoring and
Evaluation of Participants
Develop Study Specific Adverse Event Reporting
Plan
Develop Protocol and Associated Materials
Plan Study
Released
CTMS/LS Workspace Reviewed
In CTMS/LS Workspace Review
Draft / CTMS/LS Working Group
Placeholder
Legend
Plan Study > Develop Protocol and Associated Materials > Develop Study Specific Data Safety Monitoring Plan
Develop Plan for Response Assessment
«include»
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Activate a Study at the Coordinating Center
uc Initialize Operational Management Systems
Activate Study at Coordinating Center
Initialize Operational Management Systems
Maintain Organization and Study Personnel
Information
Establish Study Subject Registration
ManagementStudy Protocol Coordinator
Initiate Study > Activate Study at Coordinating Center > Initialize Operational Management Systems
Establish Study Subject Progress
Tracking
Released
CTMS/LS Workspace Reviewed
In CTMS/LS Workspace Review
Draft / CTMS/LS Working Group
Placeholder
Legend
Implement Study-Specific Adverse
Event Reporting Requirements
Initialize Image Management SystemInitialize Response
Criteria Interpretation Method
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Maintain Local/Center Radiology Sites
uc Establish Study Subject Registration Management
Activate Study at Coordinating Center
Initialize Operational Management Systems
Establish Study Subject Registration
Management
Maintian Local/Central Radiology Review
Sites
Initiate Study > Activate Study at Coordinating Center > Initialize Operational Management Systems > Establish Study Subject Registration Management
Released
CTMS/LS Workspace Reviewed
In CTMS/LS Workspace Review
Draft / CTMS/LS Working Group
Placeholder
Legend
«include»«include»
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Initialize Image Management System
uc Initialize Image Management sysstem
Activate Study at Coordinating Center
Initialize Operational Management Systems
Initialize Image Management System
Released
CTMS/LS Workspace Reviewed
In CTMS/LS Workspace Review
Draft / CTMS/LS Working Group
Placeholder
Legend
Initiate Study > Activate Study at Coordinating Center > Initialize Operational Management Systems > Initialize Image Management System
Grant Access to Systems
Initialize Image Transfer Methods
Initialize Image Worklist
Initialize Image De-identification
Method
Initialize Site Specific Image Transfer
Methods
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Initialize Response Criteria Interpretation Method
uc Initialize Response Criteria Interpretation Method
Activate Study at Coordinating
Center
Initialize Operational Management Systems
Initialize Response Criteria Interpretation
Method
Released
CTMS/LS Workspace Reviewed
In CTMS/LS Workspace Review
Draft / CTMS/LS Working Group
Placeholder
Legend
Initiate Study > Activate Study at Coordinating Center > Initialize Operational Management Systems > Initialize Image Management System
Initialize DICOM Viewer
Initialize Image Annotation tool
Initiate Image Annotation Template
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Initiating the Study at a Site
• Open Study at the Site• Verify Image Transfer Infrastructure• Conduct Study-Specific Personnel Training
• Train Staff On Response Assessment Methods• Train Staff On Image Acquisition Methods
Current BAM Status
• Clinical Research• For Translational Medicine BAM 2.0 (delivery August 2010)
• Complete the review and approve use cases for Plan Study
• Complete Initiate Study Use Cases
• Complete Conduct Study Use Cases
• Life Sciences• Delivered a high level LS BAM version 1.0 for inclusion in the
Translational Medicine BAM 2.0• Currently working on the
• Actor identification
• Extension of the use cases in LS BAM 1.0
Current BAM Status continued
• Population SciencesThe Population Science working group is working to assure that the required use cases for conducting studies and trials to support the Division of Cancer Control and Population Sciences are accurately captured in the Translational Medicine Architecture BAM
• Just getting started
• Mapping scenarios to the current Translational Medicine BAMs and extending as needed
• Extending the Plan Study Area of the Clinical Research BAM for v. 2.0
Current BAM Status continued
• PatientsThe Patient BAM will describe a cancer patient’s interaction with the Translational Medicine community, specifically related to clinical trials. This includes the evaluation, diagnosis, and treatment of a patient’s cancer as it relates to a patient deciding to participate in a cancer clinical trial. This will provide the patient’s perspective for consideration when developing requirements for systems to support the clinical trial domain.
• Began working in January
• Identified 4 high level use cases
• Currently working on Obtain Diagnosis use case
Maturing the Translational Medicine BAM
Translational Medicine BAM v 2.x: • Incorporate the work from each of the workspaces
.
Translational Medicine BAM Integration: • Continue working with the Development, BRIDG
and Enterprise Services Teams on integration and alignment.
Expansion of Translational Medicine BAM: • Expand current Clinical Research and Life Sciences
to include (Tissue Banking & Pathology, Imaging, Population Science, Patients, etc.
Acknowledgements
CTMS Sharon Elcombe CTMS SME, Mayo Clinic
Bob Morrell CTMS SME, Wake Forrest
CBIITCatherine LasomeChief Operating Officer, National Cancer
Institute , CBIIT
Denise WarzelAssociate Director, National Cancer Institute,
CBIIT
Robert ShirleyNational Cancer Institute, CBIIT
Enterprise ServicesSantosh JoshiCBIIT Enterprise Services, Ekagra Software
Brian McIndoe CBIIT Enterprise Services, Ekagra Software
Life SciencesElaine Freund LS Workspace Lead – 3rd Millennium
ImagingMia Levy, M.D.Vanderbilt Ingram Cancer Center
Questions
Links
BAM 1.1
The caBIG® Biomedical Research Business Architecture Model is available through https://cabig.nci.nih.gov/workspaces/CTMS/workspaces/CTMS/Business_Arch_Model
Additional information is also available at https://wiki.nci.nih.gov/x/fwcpAw (updated October 2012)
For more information about the caBIG® Clinical Trials Management Systems Workspace, please visit https://cabig.nci.nih.gov/workspaces/CTMS/
CTMS Forumhttps://cabig-kc.nci.nih.gov/CTMS/forums/