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**caBIG Evaluation and Priorities**

**Request for Information**

January 24, 2005

## background, Overview and Objectives of the REQUEST FOR INFORMATION (RFI)

As the caBIG project team begins to evaluate our progress in year one
and our priorities for year two, we would like to solicit input from the
caBIG community on the evaluation criteria for projects and Workspace
and Working Group participation that will be used for this
determination. In the first full year of program activity, caBIG has
generated a great deal of interest and involvement from throughout the
Cancer Center community. This diversity of opinions and expertise has
contributed to the stability and strength of the program, and it is this
diversity that the program staff hopes to draw upon in the refinement of
project evaluation criteria and review of Workspace/Working Group
participation and Program goals.

For each ongoing project, and for future projects that will be
considered as part of an upcoming Request for Proposal (RFP), the caBIG
program staff will prepare an evaluation. This evaluation will be
generated on the basis of a specific set of criteria, which are drawn
from the programmatic goals and Workspace/Working Group activities and
priorities, as well as the contractual requirements documented as part
of the program. Projects and Working Group participants will be selected
on the basis of their alignment with the priorities established for the
caBIG Workspaces and/or Working Groups, and for the program as a whole,
by the Cancer Center participants. These programmatic goals and
Workspace/Working Group-specific priorities have been established
through discussions within the Workspaces and Working Groups themselves,
and/or in the Strategic Level Working Groups.

These draft evaluation criteria and priorities are reproduced in the
following pages, for review and commentary by the caBIG Cancer Center
community. Comments from the community can be submitted via the
following URL: <http://cabig.nci.nih.gov/Year_2/RFI_Feedback_Form/>.
Alternatively, a response template can be downloaded via the same URL,
in which the comments can be sent via email to
[cabig_year2@bah.com](mailto:cabig_year2@bah.com?subject=RFI_Response).
Comments will be accepted through close of business February 4, 2005.
After the commentary period is over, the comments will be assembled and
reviewed and modifications to the evaluation criteria incorporated.
These community-generated evaluation criteria will be included in the
subsequent RFP for upcoming projects and participation for caBIG year
two. These criteria will also be used for the evaluation of project
participation and will, in part, inform decisions about funding support
for Workspace/Working Group participation in the coming year. The RFP is
expected to be released by February 15, 2005.

## Evaluation criteria

Outlined below are the current evaluation criteria for project review.

+-----------------------------------------------------------------------+
| **Evaluation Area**                                                   |
+-----------------------------------------------------------------------+
| Is there value and utility in what this project is producing for the  |
| cancer research community?                                            |
+-----------------------------------------------------------------------+
| Are the products in alignment with the current priorities and needs   |
| of the parent workspace, and the overall caBIG project?               |
+-----------------------------------------------------------------------+
| Were work products generally accurate, clear, and consistent to       |
| requirements?                                                         |
+-----------------------------------------------------------------------+
| Were tools used effectively for configuration management and progress |
| reporting                                                             |
|                                                                       |
| -   Routine and effective use of CVS                                  |
|                                                                       |
| -   Routine and effective use of caMP                                 |
+-----------------------------------------------------------------------+
|                                                                       |
+-----------------------------------------------------------------------+
| Consistently participated in teleconferences?                         |
+-----------------------------------------------------------------------+
| Agreed to develop white papers or reports; took responsibility for    |
| project activities?                                                   |
+-----------------------------------------------------------------------+
| Required documents (for Developers and Adopters)                      |
|                                                                       |
| -   Submitted in a timely manner                                      |
|                                                                       |
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| ```                                                                   |
| -   Contain sufficient level of detail                                |
+-----------------------------------------------------------------------+
|                                                                       |
+-----------------------------------------------------------------------+
| Monthly Reports                                                       |
|                                                                       |
| -   Submitted in a timely manner                                      |
|                                                                       |
| -   Contain sufficient level of detail                                |
+-----------------------------------------------------------------------+
|                                                                       |
+-----------------------------------------------------------------------+
| Deliverables invoiced promptly                                        |
+-----------------------------------------------------------------------+
| Satisfactory business/contractual relations                           |
+-----------------------------------------------------------------------+

##  caBIG PROGRAMMATIC GOALS

Outlined below are the one to five year programmatic goals as determined
through Workspace and Working Group discussions.

## *\* Note: Same as goals for Strategic Planning Strategic Level Working Group*

***1 Year (End of 2005)***

-   Develop first generation caBIG compliant tools and data sets and
    supporting data & architecture standards

-   Establish a mechanism for engaging the private sector (pharma,
    software vendors, etc.), additional cancer research organizations,
    and other Federal agencies/divisions

***3 Year (Summer 2008)***

-   caBIG will have sufficient mass of tools & data sets to have a
    positive impact on the cancer research community

-   All Developer projects will be operating under Gold standard

-   Adoption and use of caBIG interoperable tools and data sets within
    the caBIG Community

-   Develop mechanisms for engaging and promoting the use of these
    technologies and data sets for not just research but to include
    clinical treatment activities

> ***5 Year (Summer 2010)***

-   Wide spread adoption, dissemination and use of caBIG interoperable
    tools and data sets within the Cancer Community at large including
    pharma, non-NCI Cancer Centers, etc.

***Guiding Principals***

-   All software products must be optimized for change rather than
    trying to get it perfect the first time out. The ability to easily
    adapt our software products to future changes and external
    influences is essential.

-   We must have a bias for action and not get bogged down in
    deliberating everything to the nth detail

-   Always retain a patient centric focus in conceptualizing and
    developing our solutions

## Workspace/Working Group Project Priorities & Participation

***Clinical Trial Management Systems (CTMS) Workspace***

> **1 Year**

-   **Financial**:

    -   Financial glossary, functional requirements, SOW with focus on
        Clinical Trial Financial Ledger software module

-   **Laboratory**:

    -   Identify CDISC modifications, HL7 V3 messages, and produce an
        interface to Adverse Events Special Interest Group

-   **Adverse Events:**

    -   The caBIG functional prototype for Adverse Events Software
        Modules 1-4 tested at adopter sites

-   **CTMS/CDUS:**

    -   Develop and deliver use cases, establish improvements to CTEP
        reporting process

-   **caBIG Compatibility:**

    -   Develop caBIG compatibility assessment methods, gap analyses for
        several systems, create refined guidelines for assessment of
        caBIG compatibility

-   **Structured Protocol**:

    -   Create core data elements (CDISC-based) for protocol
        registration & internal tracking

> **3 Year**

-   **Financial:**

    -   Document, deploy software to users

-   **Laboratory:**

    -   Transfer data from 2 vendor systems, transfer into Clinical
        Trials databases

-   **Adverse Events:**

    -   All 12 modules in place with interfaces to vendors and agencies

-   **CTMS/CDUS**:

    -   caBIG module for CTMS/CDUS reporting, adverse event denominator
        data

-   **Structured Protocol:**

    -   Clinical trial registry, patient eligibility, patient
        registration, treatment calendar, CRFs, Summary 4, and SIG
        components

> **5 Year**

-   **Laboratory:**

    -   The Grid, Toolkit to transfer any lab data

-   **Structured Protocol:**

    -   Complete PI authoring, custom report generation, data mining,
        results repository, and statistical analysis components

***Integrative Cancer Research (ICR) Workspace***

> **1 Year**

-   A number of the Year 1 projects in ICR will reach a
    proof-of-concept, or prototype stage at the end of Year 1. For those
    in which there is significant interest, additional funding will need
    to be allocated to bring them to maturity. The majority of projects
    will target Silver Level compliance, as outlined in the caBIG
    Compatibility Guidelines document. A few projects will be selected
    as reference implementations of the Grid architecture. All projects
    will comply with the caBIG principles of open source, open access,
    open development and federation. For projects that reach
    Silver-level compliance in Year 1 and are of significant interest to
    the caBIG community, funding will be allocated to bring them into
    the grid architecture (Gold-level compliance).

-   **Integration/Scientific Proof-of-Concept -** This was identified as
    the highest priority in ICR for Year 2. The goal of such a project
    would be to employ tools and datasets developed in caBIG in Year 1
    (either within ICR or across workspaces) toward a real scientific
    problem.

-   **Completion of Year 1 Projects** - A number of the Year 1 projects
    in ICR will reach a proof-of-concept, or prototype stage at the end
    of the year. For those in which there is significant interest,
    additional funding will need to be allocated to bring them to
    maturity.

> **3 Year**

-   Bring more selected data sources and applications into Gold-level
    compliance, i.e. make them grid resources.

-   Show how a federated set of resources that are syntactically and
    semantically compatible can be used to perform powerful analyses
    across the cancer research community.

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-   **5 year**

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-   Connect the ICR data and applications to resources in the Tissue
    Banks and Pathology Tools Workspace as well as the Clinical Trials
    Management System Workspace

***Tissue Banks & Pathology Tools (TBPT) Workspace***

> **1 Year**

-   Complete first iteration of caTISSUE Core / caTISSUE Lite and deploy
    to adopter sites for testing.

-   Complete caTIES module and deploy to adopter sites for testing.

-   Complete first phase of caTISSUE clinical annotation module and
    deploy to adopter sites for testing.

> **3 Year**

-   Complete development cycle for caTISSUE Lite / caTISSUE Core

-   Complete and deploy presentation / grid layer for caTISSUE

-   Further development of clinical annotation module.

-   Development of 'second party' modules

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-   Billing / shipping

-   Request

-   Experimental annotation

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-   Addition of other caTISSUE modules based on ranking in
    prioritization matrix.

-   Explore the integration with other specimen bank systems (e.g. EDRN,
    cooperative group banks, CHTN) with caTISSUE.

> **caTISSUE and caTISSUE Lite goals and objectives**

-   Open source architecture and adherence to "caBIG compatibility"
    guidelines with regard to architecture, controlled vocabularies and
    common data elements. caTISSUE Lite will be "Silver Level" and
    eventually, "Gold Level", when grid architecture is integrated into
    the design.

-   Utilization of current specimen banking systems to generate use
    cases for model design. This will ensure that the design process
    does not "reinvent the wheel" and that caTISSUE Lite will handle all
    basic functionalities associated with the operation of a biospecimen
    bank.

-   Modular design. It is recognized that all desired functionality can
    not be built immediately into caTISSUE (hence the designation for
    this project, caTISSUE Lite). However, caTISSUE Lite will be
    designed so that additional functionality (e.g. Clinical Annotation
    Module, Biological Annotation Module, Billing and Financial Module,
    Specimen Request Module) can be added to the Core system without any
    architectural redesign.

-   A basic system that can be rapidly deployed to institutions with
    little or no specimen banking informatics. The first iteration of
    caTISSUE will be developed quickly and deployed to sites who are
    currently utilizing spreadsheets or highly customized databases
    (Access, FoxPro, File Maker) for tracking biospecimens. Rapid
    adoption of caTISSUE Lite will allow these institutions to expand
    their system with additional caBIG compliant modules over time.

-   A system to which objects and data elements can be mapped from
    legacy biospecimen informatics system. It is clearly recognized that
    not all sites can or will adopt caTISSUE Lite as their sole solution
    for specimen banking informatics. Although not within the scope of
    this proposal, adopters will have the ability to map data from their
    own systems to objects and data elements in caTISSUE Lite, so that
    they can maintain their existing systems while participating in
    caBIG.

***Vocabularies & Common Data Elements (VCDE) Workspace***

> **1 Year**

-   Plan for governance of new vocabulary and common data element
    content including establishment of review boards within VCDE WS for
    standards review and establishment of vocabulary governance model

-   Establish VCDE Mentoring Teams for domain Workspace pilot projects
    and finalize guidelines

-   Recommendation of external data standards

-   Convene regular Face to Face Meetings of the VCDE Workspace and
    joint meetings with the Architecture Workspace to address caBIG
    cross cutting issues

-   Implement VCDE Workspace developer projects

> **3 Year**

-   LexGrid Development

-   Mouse/Human Anatomy Development

***Architecture Workspace***

> **1 Year**

-   Develop and deploy the core Data Grid infrastructure. This
    infrastructure will form the nucleus architecture on which
    end-to-end, production level infrastructure will be built in year
    from years 2 through 5. It will support the minimum required
    functionality for distributed, collaborative basic research

> **3 Year**

-   Develop and deploy the core support for Grid-enabled,
    multi-institutional translational studies. This infrastructure will
    support the integration and analysis of clinical data with high
    throughput molecular data including gene array, proteomic, SNP,
    methylation and image data. The infrastructure will also support
    Grid-enabled sharing of de-identified clinical information and
    clinical trials protocols

> **5 Year**

-   Develop and deploy the full, production-level support for
    Grid-enabled, multi-institutional translational studies. This
    infrastructure will implement extended support for Grid-enabled
    clinical trials protocols and extensions to facilitate querying and
    integration of streaming sensor data (imaging, lab, other types of
    sensors) with other types of data. With this infrastructure, data
    generated at all levels of basic and clinical research can be
    captured, managed, and analyzed

***Data Sharing & Intellectual Capital (DSIC) Strategic Level Working
Group***

> **1 Year**

-   Develop key data sharing associated use cases for each of the caBIG
    workspaces.

-   Collect and compile existing "best practices" related to proprietary
    and regulatory issues for data sharing.

-   Where no "best practices" exist, seek out needed expertise to
    formulate such policies for caBIG activities.

-   Prepare position papers on assigned topics relevant to each team
    focus.Develop a caCORE Developer's Tool Kit

> **3 Year**

-   Publish white papers (consensus documents) based on summation of
    group's position papers.

-   Continue interaction with Architecture WS to develop test documents

-   Create caBIG compliant document templates that can be used by
    participating institutions to ensure compliances with data sharing
    polices

> **5 Year**

-   Serve as liaison between policy changes and system design

-   Troubleshoot remaining institutional impediments to implementing
    data sharing across the grid

***Training Strategic Level Working Group***

> **1 Year**

-   Develop caCORE training (EVS,caDSR, caBIO)

-   Develop Training for tools currently being developed starting with

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-   CTMS - Structured Protocol Development

-   ICR -- caARRAY

-   TBPT -- caTIES

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-   Develop templates & standards for caBIG Software Documentation

-   Develop common standards for the evaluation of caBIG tools

> **3 Year**

-   Provide an open source electronic learning environment

-   Define Training Modalities

-   Produce "Gold" level training materials

-   Provide a common look and feel for caBIG training materials

-   Provide end user & tech support

***Strategic Planning (SP) Strategic Level Working Group***

> *\* Please see caBIG Programmatic Goals*

## Instruction for submitting a response to this RFI

In order to submit a response or commentary to this RFI you may do so in
one of two ways. You may either fill in the form located on the project
Web site, at <http://cabig.nci.nih.gov/Year_2/RFI_Feedback_Form/>, or
you may submit a response using the template provided in Appendix I
(also available on the Web site), via email to
[cabig_year2@bah.com](mailto:cabig_year2@bah.com?subject=RFI_Response).
**[The deadline for submission of a response to this solicitation is
February 4, 2005.]{.underline}** Any response after this date will not
be considered in the production of the final RFP.

The responses to this RFI will be reviewed by the caBIG project team,
and will be used as the basis for the development of the final project
review document encompassing overall programmatic goals and
Workspace/Working Group priorities and participation.

For inquiries about this RFI, please contact the caBIG Project Manager,
Mark Adams (<adams_mark@bah.com>) or via phone at (301) 998-6934.

##