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

**Steering Committee Meeting**

**March 23, 2005**

**Agenda**

**I. Objectives for today's meeting (15 min) (Mary Jo or Ken)**

-   Discuss a project to create a common electronic infrastructure to
    support the sharing of clinical research data for faster, more
    efficient development of new drugs

-   Agree to Steering Committee Mission and Objectives.

-   Establish working groups and how the working groups and the steering
    committee will work together over the next few months.

*Introductions and a brief description of the purpose of today's
meeting. There will be :*

1.  *A brief review of CRIX*

2.  *Discuss and finalize the mission of the steering committee*

3.  *On-site work activities: Designate work groups; Each working group
    will develop a preliminary 1 year work plan and begin identifying
    the questions to be answered to move CRIX forward.*

    **II. CRIX overview (45 min) (Sue)**

*Brief overview of CRIX.*

1.  *CRIX is the new name for Mission Phoenix. (Use Sue's CRIX
    presentation as a basis for discussion- send this out to
    participants prior to the meeting---ALONG WITH FAQ)*

2.  *CRIX is a collaboration among government, industry and academia to
    implement a standards based regulatory data and document
    e-submission infrastructure.*

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

4.  *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.*

5.  *Present the global and incremental vision of CRIX*

    a.  *Show diagram of incremental, potentially parallel activities
        leading up to production components.*

    b.  *The first step is a 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.
        An important element of the pilot is the use of the "SAFE"
        standard for eSignatures. The primary objectives of the pilot
        are to prove the feasibility and value of the CRIX concept and
        to set the gold standard for 1572 information. Subsequent pilot
        projects will address other specific processes. NOTE: It is
        important to emphasize the process/approach to implementation
        since this is VERY different from Sebix which was more the "big
        bang" theory. Also, the leveraging of existing capabilities,
        etc.*

    c.  *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.*

        *Leveraging Existing Work*

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1.  *Status of the Investigator Repository (FDA Form 1572) pilot*

2.  *CRIX will leverage existing organizations, technology and knowledge
    whenever possible. Examples include security models and data
    standards.*

3.  *Template eCRFs already in existence in the caDSR, caCORE/caBIG
    infrastructure architecture, possibly CTWS SOPs under development by
    C3D users, SAE solution from COH, Structured Protocol Model from
    UPMC, HL7 messaging and clinical trial infrastructure from NCI,
    others, CDISC Domain Analysis Model, etc.*

4.  *Introduce the CTWS efforts and the ideas for a CDE/CRF driven
    information system for collection of core information.*

**(Statement from Ken if he was not present at the start -- 10 min)**

**III. The mission and objectives of the Steering Committee (30 min)**

*{discuss and gain consensus for the statement of mission and
objectives}*

*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*

**IV. Work Group Charge (15 min)**

**Planning Work Group (Mary Jo facilitates)**

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

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

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

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

c.  *Create a review committee for review and approval recommendations
    for submitted proposals*

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

    **Business Model Work Group (Sue facilitates)**

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1.  *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.*

2.  *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 (Peter facilitates)**

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

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

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

    **- Break -- (15 min)**

    **V. Parallel Activities (30 min)**

*Each work group will get started on the following activities and then
report back to the group as a whole.*

1.  *High level work plan. Part of the work plan is to decide how the
    group will meet and continue to work together.*

2.  *Develop preliminary list of questions to be addressed to make CRIX
    successful - TIME PERMITTING*

> *For example:*

-   *What are the potential self sustaining funding models for CRIX?*

-   *What policies, procedures and safeguards need to be in place to
    ensure that the CRIX solution meets industry, academic and
    government needs and requirements?*

-   *How should CRIX be positioned to serve adopters that have a range
    of legacy systems?*

    **VI. Wrap up (30 min)**

    *Work groups report progress and the next steps are documented*

    *Document agreements and action items from the meeting*

*Set next SC meeting date.*

**VII. Post meeting Firebird demonstration (30 min) - Optional**

*Read ahead information:*

-   *SC DECK (includes Sue's CRIX presentation)*

-   *CRIX Q&A -- includes SC and work group mission and objectives*

-   *CRIX Steering Committee Guidance*

-   *Firebird Q&A*

    ***The meeting will be successful if:***

1.  ***The group leaves with an understanding of CRIX***

2.  ***There is consensus around the mission and objectives of CRIX***

3.  ***There is consensus around the mission and objectives of the
    Steering Committee***

4.  ***The Steering Committee work groups are formed and staffed.***

5.  ***There is a rough work plan for the first year.***

6.  ***Each work group has its next meeting scheduled and has identified
    how the group will work together between SC meetings***