**Table of Contents**

[**Opening Statements 2**](#opening-statements)

[A. Welcome 2](#a.-welcome)

[B. Purpose and Goals 2](#b.-purpose-and-goals)

[**Strategic Plan Presentation 6**](#strategic-plan-presentation)

[A. Integrative Cancer Research Workspace
6](#a.-integrative-cancer-research-workspace)

[B. Clinical Trials Management Systems Workspace
6](#b.-clinical-trials-management-systems-workspace)

[C. Tissue Banks and Pathology Tools Workspace
8](#c.-tissue-banks-and-pathology-tools-workspace)

[D. Imaging Workspace 9](#d.-imaging-workspace)

[E. Vocabularies and Common Data Elements Workspace
9](#e.-vocabularies-and-common-data-elements-workspace)

[F. Architecture Workspace 10](#f.-architecture-workspace)

[G. Data Sharing and Intellectual Capital Workspace
11](#g.-data-sharing-and-intellectual-capital-workspace)

[H. Training Workspace 12](#h.-training-workspace)

[**Planning Sessions 13**](#planning-sessions)

[A. Domain Workspaces 13](#a.-domain-workspaces)

[B. Cross-cutting Workspaces 16](#b.-cross-cutting-workspaces)

[C. Strategic Level Workspaces 17](#c.-strategic-level-workspaces)

# **Opening Statements**

### A. Welcome

David Fenstermacher, University of Pennsylvania

-   Dr. Fenstermacher welcomed the meeting attendees and encouraged them
    to enjoy their stay in Philadelphia

-   He expressed concern about the Request for Proposal (RFP) process
    and the new participation funding model; he also encouraged the
    group to read the straw-man RFP recommendations document sent to the
    Strategic Planning Listserv

-   Dr. Fenstermacher also noted that the meeting should be conducted in
    a spirit of openness, honesty, and inclusion and that caBIG™ has
    accomplished much by working together for a greater good

### B. Purpose and Goals

Ken Buetow, Director, NCICB

-   Dr. Buetow thanked Dr. Fenstermacher for his message and highlighted
    NCICB's strong support continuing community engagement and
    community-led planning efforts in the workspaces and across caBIG™

-   Continuing to develop and refine caBIG™'s long-term plans is
    critical to the success of the program

-   caBIG™ is one of the broadest and most complicated efforts
    undertaken by the NCI

-   Dr. Buetow reviewed the caBIG™ pilot's goals:

    -   Illustrate that a spectrum of cancer centers with varying needs
        and capabilities can be joined in a common grid of
        communications, shared data, applications, and technologies

    -   Demonstrate that cancer centers, in collaboration with the NCI,
        will develop new enabling tools and systems that can support
        multiple cancer centers

    -   Demonstrate that cancer centers will realize greater value in
        their cancer research endeavors by using the Grid

    -   Create an extensible infrastructure that will permeate the
        cancer research community

-   The role of the community only grows in importance as caBIG™
    transitions from pilot to enterprise

-   As caBIG™ continues to expand we are focused not only on building
    community but also on delivering real products which solve real
    problems

-   Dr. Buetow reviewed and evaluated progress against each of the
    yearly themes:

    -   Year 1: Building Community

        -   Key goals were delivered

        -   A caBIG™ Community was established

    -   Year 2: Delivering Products

        -   caBIG™ is on the path to success, we are:

> \- working toward implementing caGRID version 1.0
>
> \- developing a greater number of vocabularies
>
> \- deploying an increasingly rich collection of tools

-   Year 3: Real Solutions for Real Problems

    -   Year 3 is an important year for the program, we look forward to
        deploying more tools and connecting to an even broader community

    -   We will continue to support the integration of tools and
        methodologies across workspaces and content areas (e.g.,
        clinical trials and tissue banking)

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-   caBIG™ is growing in visibility and influence; caBIG™ compliance is
    increasingly being required of NCI-produced and supported
    applications

-   caBIG™ has achieved traction; groups are coming to caBIG™ to utilize
    its infrastructure

    -   Examples include Specialized Programs of Research Excellence
        (SPOREs), Cooperative Groups, EDRN, The Cancer Genome Atlas
        (TCGA), and Clincial Trials Working Group (CTWG).

    -   The program is continuing to increase its engagement with other
        organizations

-   caBIG™ has also garnered the attention of Fortune 500 companies
    (e.g., IBM, Hewlett Packard, Siemens, and General Electric)

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-   We have several specific goals in the Strategic Planning Workspace,
    key among these are:

    -   To develop a strategic plan that communicates caBIG™'s strategic
        vision, mission, goals, and objectives for the short-, mid-, and
        long-term

    -   To support integration across caBIG™ by identifying touch points
        across workspaces and tools

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-   The objective of this meeting is to think strategically, to
    illuminate the challenges we will overcome in Year 3, and to define
    plans for doing so

    -   The strategic plan must be more than an operational view of how
        the groups function---it must be a plan to sustain and integrate
        all parts of caBIG™

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-   Questions/Comments:

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-   *Has the mission changed from creating a self-sustaining enterprise
    within caBIG™ to achieving complete harmonization with the rest of
    the NIH*?

    -   Our success has been our openness. People are expressing
        significant interest in caBIG™, and because this program is an
        open collaborative enterprise, it should welcome the involvement
        of other groups

    -   We should maintain the focus on caBIG™ as a self-sustaining
        community; however, as the program grows our collaboration with
        other groups will naturally increase

-   *Should the program examine which activities to continue and which
    to conclude?*

    -   We are always evaluating our priorities and how best to achieve
        them; a natural part of this process is evaluating if any
        current activities should be phased out and what new activities
        should be started

-   *Institutional Clinical and Translational Science Awards
    (CTSA)---there is a perception that clinical informatics, at the
    roadmap level, involves everything but bioinformatics*

    -   How the National Center for Research Resources (NCRR), NIH, and
        NCI interact is beyond the scope of caBIG™. It may appear that
        these groups are intentionally excluding caBIG™; however, there
        are signs that NCRR is interested in caBIG™.

-   *CTSA appears uninterested in multi-institutional networking / data
    sharing*

    -   The IT components of CTSA were intentionally broadly defined, as
        the complete roadmap was not yet defined at that point

-   *There are plans to create a committee within CTSA to monitor IT
    evolution and happenings*

    -   This community, as thought leaders, needs to ensure that CTSA is
        well informed about caBIG™. Currently, there is a significant
        disagreement concerning the validity of the standards-based
        approach to science.

## Strategic Plan Presentation

-   The notes below capture post-presentation comments, questions, and
    discussion; please see the caBIG™ website to view the complete
    presentations

-   <https://cabig.nci.nih.gov/working_groups/SP_SLWG/Meetings/Strategic_Planning_SLWG/Face_to_Face_Meetings/March_2006/March_2006_Face_to_Face>

-   Comments and general discussion are noted in standard font;
    direction questions are noted in *italics*

### A. Integrative Cancer Research Workspace

Michael Ochs, Fox Chase Cancer Center

-   The development of translational tools is integral to all workspaces
    and to caBIG™ as a whole

-   The tools being developed in ICR are critical to the program

-   There must be continuity in funding as projects in ICR continue to
    grow

### B. Clinical Trials Management Systems Workspace

Joyce Niland, City of Hope

David Fenstermacher, University of Pennsylvania

-   Accurately defining and mapping interactions between systems can be
    laborious, but defining these interactions is crucial to the
    longevity of the CTMS workspace. It is imperative to adequately
    determine the foundational layout of interactions between systems

    -   Perhaps the Tissue Banks and Pathology Tools Workspace provides
        the best case for harmonizing applications and integrating
        applications

    -   TBPT's goal is building foundational software on which
        applications can be developed; without this foundation, it is
        difficult to create new tools. CTMS lacks a focus on
        foundational development.

    -   The TBPT Workspace began with modularity and will proceed with
        integration

    -   In the absence of foundational software, the group can utilize
        an API/COTS solution; either way, the group needs to plan for
        the integration of all of the parts

-   *Will the tools currently in development be useful?*

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-   CTMS will not be viewed as a success until it can deliver a complete
    package of tools to clinicians that look and feel similar to one
    another

-   Modularity is a significant strength of caBIG™; the goal is not to
    produce a single package, but to create a cohesive system made from
    several modules

-   A complete roadmap helps ensure successful modular software

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-   *What is the role of vendors?*

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-   The involvement of industry partners is vital to caBIG's™ success

-   If the community is adopting commercial tools, caBIG™ should engage
    the vendors providing these tools

-   The proposed Bronze level certification process will encourage
    continued engagement with the vendor community

### C. Tissue Banks and Pathology Tools Workspace

David Fenstermacher, University of Pennsylvania

-   The connections between Imaging and TBPT, between radiology and
    pathology, are critically important. Both radiology and pathology
    have similar needs related to image data: annotation, description,
    and storage. In the end, the software needs of the two groups are
    similar.

-   *To what extent does this workspace (TBPT) provide the architectural
    concepts for linking all of the disparate parts of tissue banking to
    clinical trials?*

    -   This group needs a portal within the network to examine various
        parts of the infrastructure to be able to orchestrate workflows

    -   The Architecture Workspace is narrowly focused around the GRID,
        rather than unifying architectures across projects

    -   This group is charged with designing tissue models for CTMS

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-   TBPT will have made many significant accomplishments by the end of
    year three, but the goals for TBPT extend beyond that timeframe

    -   A central goal of the pilot is to prove caGRID capability

    -   NIH will experience budget cuts this year for the first time in
        40 years and caBIG™ must continue to be seen as part of the
        solution; this can be achieved by demonstrating that caBIG™
        leads to overall lower Cost of Ownership for research tools and
        systems.

    -   It is critical that caBIG™ continues to produce deliverables in
        the Tissue Banks \[and Pathology Tools\] Workspace, these
        deliverables are a visible item on the NCI agenda; the program
        must also demonstrate data sharing

    -   Other key goals include enabling a standards-based approach to
        clinical research and demonstrating interoperability between
        participating institutions

### D. Imaging Workspace

Joel Saltz, Ohio State University

-   *When will Enterprise Applications become available?*

    -   Enterprise Applications will not be available for some time

    -   Some scenarios will be up on the testbed shortly; individual
        tools may be compromised while efforts are focused on the demo

### E. Vocabularies and Common Data Elements Workspace

Chris Chute, Mayo Clinic

-   *Are there enough resources to cover all of the upcoming reviews?*

    -   Currently, at its inception, the group is in a challenging
        phase; harmonizing data models is laborious, but the
        harmonization-related workload will decrease with success

    -   Certification-related pressure should ease with the rollout of
        caBIG™ certified UML models

    -   The group has increased the number of participants within VCDE
        and every participant is conducting reviews

    -   The fundamental roll of VCDE is to engage in the review of
        systems

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-   *Will VCDE's certification role move to the other workspaces?*

    -   Certification could move to nonprofit organizations

-   *Some groups are looking to bring the EVS and caDSR in-house. Is
    there any thought to creating push-pull mechanisms for this?*

    -   LexBIG's architectural schema explicitly allows for this;
        however, it will not be implemented in its first release

    -   Groups can request their own contexts for individual use at NCI;
        this is an alternative, until a push-pull internal concept is
        available

-   Workspaces are struggling to harmonize their models internally

    -   VCDE and the caDSR provide touch points between all UML models
        and other models on a concept-per-concept match; however, this
        does not provide for the scientific harmonization of ideas

    -   This group plans to develop a mapping service in order to supply
        a translational layer between different scientific
        organizational models

### F. Architecture Workspace

Joel Saltz, Ohio State University

-   *Is information architecture within the scope of the Architecture
    Workspace?*

    -   The metadata management, defining/coordinating models and
        objects, is within their purview, but the metadata curation is
        not

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-   *Does the group consider it desirable to have one overarching model,
    from which the entire project can descend?*

    -   Strategically, the group should develop a plan and
        operationalize this question

    -   From an architectural point of view, it is best to separate the
        information model from the implementation of the infrastructure

    -   It is ideal to separate your system into layers to allow for
        change

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-   Strategic planning needs to determine how the caBIG™ program will we
    deal with the coordination (ARCH or VCDE) of harmonizing thought
    models

-   There is a different between harmonization of thought models for
    research (semantic interoperability) and data model harmonization
    (syntactic interoperability). It is still unclear whether caBIG™
    needs a cross cutting domain model to achieve semantic
    interoperability

    -   One suggestion was to examine if the BRIDG Model could be
        expanded to create a caBIG™ wide data model

        -   BRIDG is not a data model, but rather a domain analysis
            model

    -   The group needs to think about all of the exposed aspects of the
        various data models and determine what solution is necessary

### G. Data Sharing and Intellectual Capital Workspace 

Bob Robbins, Fred Hutchinson Cancer Research Center

-   Strategic Goals

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-   Formulate caBIG™ governance policy

-   Increase awareness and cooperation among participants and Internal
    Review Boards

-   Draft responses to specific caBIG™ community questions and concerns

-   Develop white papers on Regulated Information Exchange (REI)

-   Determine the needs for 508 compliance within caBIG™

### H. Training Workspace

Jessica Bondy, University of Colorado

-   Commercial partners are a component of caBIG™'s sustainability

-   Training is charged with identifying resources to complete training
    documentation (GForge, BRIDG, caBIG™ Primer, UML Modeling, etc.)

-   *What are we doing to ensure that mentoring activities are efficient
    and effective? Can we design common frameworks?*

    -   Training may need more explicit guidance from technical, policy,
        and strategic standpoints---what kind of policies are being
        developed and where do they live?

    -   Each workspace must work to utilize their liaisons more
        effectively

    -   One solution is to create cross-workspace committees (e.g.
        Mentoring SIG)

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-   *How are we going to operationalize improvements in Mentoring?*

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-   Training will coordinate the adoption of Mentoring Best Practices

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-   Software validation and 21 CFR Part 11

    -   Utilize commercial training

    -   Proactively layout which aspects of 21 CFR Part 11 that caBIG™
        will and will not require compliance, rather than in an ad hoc
        fashion

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-   *How does the Training Workspace fit the needs of new participants?*

    -   Boot camps do not accommodate new participants needing immediate
        information and training, but self-paced resources will

-   *Things will change over time -- how will training work within a
    "living" caBIG™ where tools are released, and then changed?*

    -   This workspace will collect developer and adopter feedback on
        the current process

    -   The program needs a scaleable alternative to mentoring

    -   In general, open-source systems support themselves; commercial
        partners provide support on a fee-basis

## Planning Sessions

### A. Domain Workspaces

Leslie Derr, NCICB

-   ICR encompasses many components of the caBIG™ program

    -   Need conceptual models

    -   Translation efforts are resonating in the cancer center
        community

    -   Demos, similar to the translational effort, would garner similar
        interest

-   Can the Strategic Planning Workspace determine how to support
    volunteer efforts? Also, can they determine how to locate and engage
    volunteer groups?

-   Developing mentors requires extensive efforts

    -   caBIG™ will only succeed if current members reach out and assist
        others

-   How do the four models of TBPT, ICR, CT, and IMAG fit together?
    Where is harmony occurring?

    -   Need to look at eligibility, which means gene expression and
        imaging

![](media/image1.wmf)

-   The program needs a set of rules for the rules engine

    -   All rules are currently being hard-coded

    -   Eventually, the rules engine must be user-configurable

    -   The TBPT and CTMS workspaces should build a common rules engine

-   Examining scientific papers can reveal touch points

-   Should Architecture develop a rules engine or workflow?

    -   A workflow will be developed in the next five years

-   caBIG™ requires a collaborative effort to establish rules for 21 CFR
    Part 11

    -   Requirements should not be replicated within each group

    -   This is a great opportunity for mentoring and engaging the FDA

    -   A task order can provide funding for mentoring efforts

-   In dealing with the issue of resources, the Strategic Planning
    workspace must identify key efforts and project while planning for
    the future

-   Workflow

    -   caBIG™ is not merely a five year exercise

    -   Short-term harmonization is possible

    -   The tools must be practical for the users

-   Can we actually create a set of generic components (serving as the
    grid query tools, data-marts, etc.) and form the foundation of a
    user-friendly portal?

    -   First, establish vision through wireframes to evaluate the
        overall capabilities of the wider community

        -   The caGRID demo is failing to engage the domains, which is
            key; without doing so it will not be useful to or stimulate
            the end-users (nurses, clinicians, etc.)

    -   Second, identify what will be layered on top of these tools

    -   Several Architecture Workspace members are also involved in
        other workspaces. The community is spread thin, so it is
        necessary to carefully select key efforts.

-   Portal and Usability Testing

    -   The highest value of caBIG™ is the its infrastructure and
        architecture

    -   Four or five interconnected applications would provide the
        necessary political cover for Architecture

    -   A common tool interface is needed to ensure consistency across
        applications

    -   The program must remember that the end users have a domain focus
        and need practical solutions

-   How can we bring various user communities to the table?

    -   Develop five or six user "toys"

    -   P50 grants are inherently interoperable as they are granted to
        projects that spread across multiple institutions

    -   The Imaging Workspace created a list of non-institutional,
        orthogonal projects

-   CTMS Workspace

    -   Middleware, interoperability standards, object modules, and
        common standards are all important to CTMS; however, there is
        still a call for end-user apps to show the power of these parts

    -   There is no one size fits all solution; it is necessary to stay
        modular and deliver on all components (end-user applications,
        middle-ware, harmonized vocabulary, etc.)

    -   There is still a void in CTMS with respect to creating a
        structured protocol

        -   In the original surveys, electronic representation of
            protocols was not identified as high priority

        -   Authoring a protocol and developing an electronic
            representation of a protocol are not the same

        -   NCI is investing significant resources in electronic
            representation of protocols

        -   BRIDG is the long-term infrastructure. The longer term
            scope, prioritization, and independencies have yet to be
            defined

-   What does caBIG™ compatibility mean in terms of the architecture of
    systems?

    -   If someone retrofits a study calendar to fit caBIG™, but does
        not use BRIDG, is it compatible?

-   What fraction of modules can be safely dedicated to building
    middleware?

### B. Cross-cutting Workspaces

Leslie Derr, NCICB

-   The group has made some progress in determining the usage scenarios
    that will inform the planning of the security components

-   Currently, there are limitations on the group's commitments

-   Incrementally implement trust models between all of the cooperative
    groups

-   Engage the end-users and prepare their data for exposure to the Grid

-   There is a misconception that standing up data would require
    starting from scratch; this is not the case, as groups usually
    develop a data model in the same format as their databases

-   Semantic interoperability is not a domain analysis issue; it
    requires an identifier for a specimen, not a high-level definition

-   Goals:

    -   Data quality and stability

    -   Security and patient privacy

    -   Model harmonization

    -   Shared models

-   Identify the next black box

-   Identify or develop tools to ease integration

### 

### C. Strategic Level Workspaces

Leslie Derr, NCICB

-   What are the touch points?

    -   Mentoring in the context of training

    -   Common tools, common frameworks

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-   What services will the Clinical Trials Management Systems provide
    around patient data identification and privacy?

-   What kinds of policies are being developed and by whom?

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-   Utilize liaisons more effectively

    -   Increase coverage and depth of workspaces

    -   Identify the coordinator for this effort

    -   Ensure that Strategic Planning Workspace members are involved in
        other workspaces

-   CaBIG™ support

    -   Applications: NCICB currently acts as the initial clearing house
        for this support data

    -   Grid

        -   Who will run and operate the grid as a whole?

        -   How is the group going to structure this organization?

        -   Security policy must be instantiated and evaluated

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    -   Where should the Training and DSIC workspaces intersect?

    -   Who will be responsible for writing security and infrastructure
        patches?

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-   Will caBIG™ resemble the internet, or will it serve as a fully
    integrated data and knowledge grid?

-   The Training and DSIC workspaces are necessary to caBIG™, but are
    not easily funded. How do we plan to support these workspaces?

    -   Cancer Center Support Grants (P30) is a possible option for
        future funding; there are also a number of other alternatives

-   Data certification

    -   Will it be difficult to submit data to regulatory bodies unless
        one can illustrate 21 CFR Part 11 compliance?

    -   Would the NCICB certify data? The Nature Publishing Group is
        interested in this model, and they are highly experienced in
        data curation

    -   What are acceptable restrictions for sharing data? What are the
        extreme parameters for grid support?

    -   How does one install, validate, audit, and use 21 CFR Part 11?

        -   Eventually, this process will be necessary to ensure
            consideration of patient data; a determination is required
            before building the software