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**The Clinical Research Information Exchange (CRIX)**

**Steering Committee Meeting**

Meeting Notes

March 23, 2005

Attendees:

  ------------------------- ---------------------------------------------
  Ken Buetow                NCI/NCICB

  Bill Barrick              NIAID

  Sue Dubman                NCI/NCICB

  Mary Jo Deering           NCI/NCICB

  Erin Iturriaga            NCI/DCP

  Peter Covitz              NCI/NCICB

  Christo Andonyadis        NCI/NCICB

  Donna Marinucci           Coalition of Cooperative Cancer Groups

  Deborah Collyar           Patient Advocates in Research

  Joyce Niland              City of Hope Cancer Center

  Kim Johnson               Duke University

  Sharon Elcombe            May Clinic

  Pat Skarulis              Memorial Sloan Kettering

  John Speakman             Memorial Sloan Kettering

  Judy Evans                CDISC

  Ed Maibach                Consultant

  Becky Kush                CDISC

  Charles Mead              HL7

  Guy Tallent               SAFE

  Bill Rosen                Pfizer

  Betsy Fallen              Merck

  Thomas Scarnecchia        Biotechnology Industry Organization

  Charles Jaffee            American Medical Informatics Association

  Kamal Narang              Consultant

                            

  Scott Finley              Booz Allen Hamilton

  Chalk Dawson              Booz Allen Hamilton

  Mark Adams                Booz Allen Hamilton

  Greg Brolund              Booz Allen Hamilton
  ------------------------- ---------------------------------------------

Meeting Notes:

**1. Objectives for today's meeting**

The meeting was opened by Mary Jo Deering. Mary Jo discussed the purpose
of the meeting and presented the proposed mission and objectives of the
Steering Committee. (see the attached power point file, "CRIX Steering
Committee March 23.ppt").

Ken Buetow reported that he had just finished meeting with Dr. Zerhouni
and Dr. von Eschenbach, and they both expressed full support for the
CRIX initiative and the Steering Committee's work.

**2. Sue Dubman presented an overview of CRIX.**

-   An open collaborative effort to build a Clinical Research
    Information Exchange (CRIX) with participants from among government,
    industry and academia:

    -   caBIG Community

    -   Industry -- PhRMA and BIO representatives

    -   Standards Community -- CDISC, HL7, SAFE

    -   Patient Advocates -- Patient Advocates for Research

    -   Government -- NCI (CTEP, DCP, NCICB) initially, expanding to
        other NIH institutes and other agencies in next phase

    -   *\* FDA in special, independent role as provider of
        requirements, policies, and regulations*

-   CRIX leverages work done by SAFE (Secure Access For Everyone) and
    DHHS for identity management.

-   CRIX has grown out of needs identified in the NCI-FDA Inter-Agency
    Task Force and will leverage caBIG infrastructure, standards and
    tools and be consistent with caBIG principles.

-   CRIX will be developed in manageable increments.

    -   The first step is the Firebird pilot project that automates and
        centralizes the FDA's Form 1572 registration process. The pilot
        enables investigators to register online with NCI and other
        sponsors, including biotechnology and pharmaceutical companies.

    -   Ultimately, CRIX will provide a portal for electronic submission
        of all regulatory filings, including continuous marketing
        applications. CRIX will also support e-clinical data collection.

        **3. Ken led a discussion of the mission and objectives of the
        Steering Committee**

Mission:

-   This committee will guide the CRIX through its initial start-up and
    prepare the permanent operational, management, and governance
    structure for CRIX.

Objectives:

1.  Provide input and guidance into the initial launch and ongoing
    operation of the CRIX initiative

2.  Identify new partners for inclusion in the implementation and
    oversight of the initiative during the pilot phases

3.  Establish priorities for development and deployment of CRIX
    capabilities

4.  Develop a strategic plan, goals, and milestones for the launch and
    operation of the program

5.  Identify barriers to CRIX implementation and recommend courses of
    action for developing solutions

6.  Develop the conceptual approach to defining a funding mechanism(s)
    to support CRIX from launch though operation & maintenance. Models
    may include partnership programs, fee-for-service entities,
    contract-based entities, or hybrids of these.

The Steering Committee's next responsibility will be to develop a
selection process to identify an organization that would provide the
operation and maintenance support activities for CRIX. This process will
include:

1.  Define a process for sourcing and selecting potential organizations
    to implement the operational and technical management

2.  Define the selection/evaluation criteria for review and approval of
    proposals from interested organizations

3.  Create a review committee for review and approval recommendations
    for submitted proposals

The Steering Committee's final responsibility will be to develop a long
term governance model for the CRIX initiative after award of the
operation and maintenance organization

Ken suggested that the Steering Committee should plan to complete its
work in a fixed time frame and proposed 1 year as a reasonable target.

**5. Ken suggested that the work of the Steering Committee could best be
accomplished by dividing the members into several work groups. Mary Jo
described the roles and responsibilities work groups as follows:**

**Planning Work Group**

-   Develop a strategic plan, goals, and milestones for the launch and
    operation of the program

    -   Develop a selection process to identify an organization that
        would provide the operation and maintenance support activities
        for CRIX. This process will include:

    -   Define a process for sourcing and selecting potential
        organizations to implement the operational and technical
        management

    -   Define the selection/evaluation criteria for review and approval
        of proposals from interested organizations

-   Create a review committee for review and approval recommendations
    for submitted proposals

-   Develop a long term governance model for the CRIX initiative after
    award of the operation and maintenance organization

    **Business Model Work Group**

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-   Develop the conceptual approach to defining a funding mechanism to
    support CRIX from launch though operation & maintenance. Models may
    include partnership programs, fee-for-service entities,
    contract-based entities, or hybrids of these.

-   Collaborate with the Firebird pilot project team to identify
    industry best practices to assist in the development of the pilot to
    an operational component of CRIX.

    **Standards and Architecture Working Group**

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-   Propose standards for data and forms that should be included in
    pilot projects.

-   Identify gaps in current standards and engage the Federal
    Consolidated Health Informatics (CHI) to identify and adopt
    appropriate standards to fill the gaps.

-   Collaborate with caBIG vocabulary and architecture workspaces to
    identify and reuse vocabulary and architectural components for CRIX.

    **6. The working groups met to discuss the high level work plan and
    the objectives of the groups.**

    The working groups reported to the Steering Committee as a whole as
    follows:

    **Planning Work Group**

    The planning work group was facilitated by Mary Jo Deering. The
    group decided to proceed with the following activities:

    -   Inventory users/clients (both senders and receivers) and assess
        their needs to ensure that CRIX modules will be utilized.

    -   Develop a \"Requirements spec\" for the necessary attributes;
        include input from FDA as well as other
        stakeholders/clients/customers/users.

    -   Define/assess value propositions for the different stakeholders
        (e.g. CTEP); use this assessment to determine the appropriate
        scope of CRIX.

    -   Conduct an environmental scan of potential governance models,
        both those suggested by the business model(s) as well as casting
        a wider net to include the caBIG model, HL-7, CDISC, MedDRA,
        VISA, FannieMae, etc.

    -   Inventory/prioritize interfaces/points of contact between CRIX
        and the various clients as well as information
        sources/destinations.

    -   Define primary and secondary products \[software, processes, and
        data repository\] - CRIX \"lines of business\"; Consider
        \"product lines\" vs. \"toolkit\"; Define the appropriate
        branding/marketing.

    -   Inventory expertise/resources among steering committee members.

    -   Monthly in-person meetings for the first three months, then
        reassess; coordinate these with the other work groups; this is
        per Kim Johnson\'s observation that it\'s difficult to get work
        done between meetings.

        **Business Model Work Group**

        The group was facilitated by Sue Dubman.

        The group decided to focus on the following 2 main goals and the
        group developed a set of questions that need to be answered for
        each goal:

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-   Goal #1: Define Sustainable Business Model

    -   What are possible, self sustaining funding models for CRIX?

    -   What can we learn from SEBIX and SAFE initiatives?

    -   What are the potential barriers to success and how do we
        overcome them?

    -   What is the right way of incubating things?

    -   How do we evaluate and select the best models? What are the
        criteria for success?

    -   What are the entity structure and governance considerations?
        (e.g., regulatory limitations, role of investors in CRIX
        development, etc.)

    -   What should be the role of government agencies in the governance
        of the CRIX entity? the role of industry? the role of academia?
        the role of patient advocates?

    -   What are the do's and don'ts of government agency participation
        in external entity governance?

    -   Should the structure be non-profit (strategic investment) or
        profit making?

    -   Who are all the potential stakeholders that need to buy into the
        recommendations and how do we engage them in the process?

    -   What is the process for communication of recommendations to
        ensure broad community buy-in?

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-   Goal #2: Make Firebird Pilot Operational

    -   What lessons have we learned from the technical pilot going on
        now? What worked, what didn\'t, how does Firebird fit with
        current industry, NCI, and site processes?

    -   How do we transition from pilot to production?

    -   Who owns CRIX?

    -   What have we learned in the technical pilot that will help in
        sizing and configuration of the Firebird production system?

    -   How can we get additional input on Firebird functionality from
        the broader community of interest, not just technical pilot
        participants? How do we ensure that key functional requirements
        are included so that there is strong industry, academia and
        government acceptance and actual use of the system? 

    -   How can we broaden industry, academia and government
        participation in the next phase, the operational pilot?

    -   How do we ensure operational success for the Firebird pilot?

    -   What should the role of the FDA be in ensuring success of the
        Firebird pilot?

    -   Process for moving Firebird from technical pilot to operational
        pilot to production?

        The group decided to meet by tele-conference in 2 weeks to
        absorb materials and discuss a plan for the next steps.

        Sue Dubman captured the group's discussion in the attached
        PowerPoint presentation ("CRIX Biz Model Group 052303.ppt").

        **Standards and Architecture Working Group**

> The work group discussion was facilitated by Christo Andonyadis
>
> ===========================================
>
> Operational issues:
>
> Meeting schedules: Every two weeks. Via teleconference. Tuesday
> 1:00EST. Next meeting in April 5th. Face to face meeting? 1/2 day
> meeting every fourth meeting, also Tuesday afternoons.
>
> **\
> Action Items:**

-   Put distribution list together and circulate.

-   Kamal will circulate the spreadsheet and UML representing the
    use-cases and CDEs in Firebird.

-   Schedule and circulate the meeting details. Set up phone telecon and
    web bridge

-   Charlie to circulate mission statement for group to the distribution
    list.

> \"We need to understand what data is being passed back and forth, and
> is it to be understood only by humans, or to be computable? The task
> for machine computability is more complex. We wills tart by
> reverse-engineering and looking at the pilot project, and then make
> suggestions about how to make it more robust using the appropriate
> standards\"
>
> This group needs to formalize a methodology to carry that charge (find
> standards and Teleconferences, as well as email to move documents. Web
> collaborative environments. Breeze for NIH.
>
> ===========================================
>
> Meeting Notes:
>
> (About ½ hour of discussion)
>
> Christo went over the agenda for the meeting, covering all the
> discussion items in the breakout list.
>
> He also outlined:
>
> \- The standards and how they are going to change over time.
>
> Charlie Mead: His concern about he group is that it is technology
> looking for a problem. he would like to understand exactly on a much
> better level what the problem we are trying to solve.
>
> Christo: CRIX stands for Clinical Research Information Exchange. As we
> all know, in order to do that with minimum loss of information, we
> need semantic interoperability in order to make it work \[Firebird
> 1571/1572 are the two standards that exist -\> firebird\] HL7 CDA
> (clinical document architecture) which has a human-readable and
> computable component.
>
> 1571-2s are not standards, they are forms. PDF, for example is not a
> computable standard, solely human-readable. We have to make the
> decision about what information in a given CDA instance needs to be
> computable, and what is going to be passed around for people to look
> at. In Firebird, the sponsors want digitally signed PDF documents that
> they can put in their database. They will also want computable
> documents that they can put in their local information systems,
> allowing them to populate systems with investigator information,
> including what protocols they are involve. Underlying data, with the
> PDF as a layer above, carrying the required digital signatures.
>
> Charlie- what is the subset of the data which needs to be semantically
> interoperable and computable? How does this match their uses?
>
> John S. How does this relate to the data we are already
> keeping/capturing in the CDISC form? Regulatory / statutory ideas like
> \"investigator\" and \"site\" are defined in regulations.
>
> Credentialing. for example, the HL7 RIM standard within the military
> health infrastructure. Machines can make decisions about someone\'s
> credentials- applying rules against credentials. There is a set of
> coded concepts (common language privileging - maps to CPT codes, about
> 8000). The end point is: "you can do cardiac surgery and you can\'t\"
>
> Charlie: For example, \"I want to schedule cardiac surgery- I need to
> be credentialed and privileged to do that process, there need to be
> the resources, and the patient needs to be appropriate for that\" You
> need computable semantic interoperability- needs to be based on a set
> of terms that can be passed around to machines.
>
> For this group- what is the process that identifies the information
> that is supposed to be semantically interoperable and computable? We
> need to know what information there is which needs to be computed.
>
> More than meta-data in tags which can be passed around and displayed
> for people, which is easy.
>
> For a regulatory guy- this stuff is not there yet at the level of DoD.
> There are no computable rules yet applying to who is allowed to do
> studies under what context.
>
> One of the major issues that they have been struggling with in
> Firebird is to have consistent place names. Also that there is not yet
> a standard for all labs in the country- what labs is a given
> investigator using. If there is a problem at a given lab, the FDA can
> run a query. IRB naming standardization is also needed. CTEP has a
> codified list of 10k organization, 15k investigators- no current labs
> list. How do you uniquely identify these 4 things, and people?
>
> You want to distinguish the entity as opposed to the action. The CTEP
> data is what they initially went with for Firebird, but we as a CRIX
> group need to agree on these.
>
> Charge of the group is to facilitate the proposed standards for data
> that need to be included in the pilot standards. How do we discover
> that data standard. In order to do that we need the entities, the
> actions, and some use cases in order to do that. In fact, we may not
> find any existing standard for this particular problem. Others like
> JAMIS we may be able to do that activity. We need to understand more
> about the information required for the projects in order to do that
> activity.
>
> The FDA is the one group that needs to be talked to.
>
> How does this group interact with the standards group at the caBIG?
> caBIG has Vocabulary and Architecture workspaces, and they are working
> on agreed-upon caBIG certified versions of things. For example race
> and ethnicity. Certainly we have to work with them- what is the
> mechanism for this. Perhaps having Peter in the work group will
> provide that link.
>
> FDA\'s non-involvement is likely to be political. Going forward can
> they be involved in any larger way? Any FDA questions that we have, we
> can find ways to get them to the FDA.
>
> How do we figure out what information is supposed to be semantically
> interoperable? Perhaps we can reverse-process engineer existing
> firebird- who are the stakeholders, what are the processes, and then
> go and find the standards that can be used for those standards. An
> excel spreadsheet with all the CDEs in firebird

**7. Wrap-up.** The meeting concluded with a discussion of possible next
meeting dates and an agreement that each of the work groups will meet
independently and be prepared to discuss their progress at the next
Steering Committee meeting.

The date of the next Steering Committee meeting was not set,.It is
intended that there be quarterly meetings A call for calendars will be
sent out.

The meeting was followed by a demonstration of Firebird