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

**Business Model Committee Meeting**

Meeting Notes

May 25, 2005

Attendees:

  ------------------------- ---------------------------------------------
  Sue Dubman                NCI/NCICB

  Erin Iturriaga            NCI/DCP

  Wendy Patterson           NCI

  Mary Jo Deering           NCI/NCICB

  Mike Montello             NCI/CTEP

  Donna Marinucci           Coalition of Cooperative Cancer Groups

  Deborah Collyar           Patient Advocates in Research

  Joyce Niland              City of Hope Cancer Center

  Sharon Elcombe            May Clinic

  Pat Skarulis              Memorial Sloan Kettering

  Rachael Karle             BIO/Genzyme

  Betsy Fallen              Merck

  Thomas Scarnecchia        Biotechnology Industry Organization

  Charles Jaffee            American Medical Informatics Association

  Chalk Dawson              Booz Allen Hamilton

  Kamal Narang              CTIS
  ------------------------- ---------------------------------------------

Meeting Notes:

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

-   Firebird/SAFE Pilot - Get feedback on the benefits of Firebird/SAFE
    to the academic research community.

-   Stakeholder Analysis - Work through the stakeholder template
    developed after the last meeting. Identify who the stakeholders are
    for CRIX from a provider and consumers perspective.

-   Vendor Support Analysis - Identify a list of sources (e.g. non
    profits, contractors, pharma, etc) to provide CRIX support services,
    and the advantages and disadvantages associated with each source.

-   Paying for Services - Discuss the general reasons why one would not
    be willing to pay for these services, and identify attractors and
    detractors for each user group.

-   Pricing Model Analysis - Work to identify a list of pricing models,
    starting with those identified during the last meeting. Identify the
    advantages and disadvantages of each pricing model.

    **2. Discussion of Definition of Terms**

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-   Provider - a person or organization that supplies data or
    information to the CRIX environment that may be consumed, used, or
    incorporated into another organization\'s activities

-   Consumer - a person or organization who would access, use, or
    incorporate information into their activities

    **3. Firebird/SAFE Pilot**

    Kamal Narang & Sharon Elcomb provided an overview of the lessons
    learned from the Firebird Pilot. See attached briefing. Other
    lessons learned or observations noted below:

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-   The cost of deploying the required hardware for the SAFE
    authentication appears to be an obstacle since the maintenance of
    the 1572 is an annual activity. However, is this technology could be
    used to sign CRFs, it could make it cost effective. For now a
    central kiosk model is being used to provide the PI access to
    Firebird.

-   The big savings is at the 1572 coordinator level, especially if the
    FDA would accept a model that would allow the coordinator to certify
    that the personally witnessed the wet signature on the 1572.

    **4. Stakeholder Analysis**

    The group identified a possible lit of stakeholders, their role in
    CRIX, the anticipated benefits to the stakeholder, the incentives to
    use CRIX, and the disincentives to using CRIX. See attached analysis
    template for the outcome of this discussion.

**4. Vendor Support** -- This topic was deferred to the next meeting.

**5. Paying for Services** -- This topic was deferred to the next
meeting.

**6. Pricing Model Analysis** -- This topic was deferred to the next
meeting.

**7. Action Items**

-   Betsy Fallen -- Follow up with Bill Rosen to get a copy of any
    analysis of the costs involved with the paper process for
    investigator registration.

-   Kamal Narang -- forward a copy of the Firebird Lessons learned
    briefing to the group

**8. Wrap-up**

The meeting concluded without a discussion of possible next meeting
dates. There will me a face to face meeting of the entire CRIX Steering
Committee on June 30, 2005 in the PhRMA offices is Washington, DC.