+------------------+---------------------------------------------------+
| Date, Time &     | *August 31, 2005* from 9:00 AM to 3:00 PM PCT     |
| Location:        |                                                   |
|                  | UCSF, Rock Hall Auditorium, 1550 4th Street, Room |
|                  | 102                                               |
+------------------+---------------------------------------------------+

Attendees:

+-----------------------------------+-----------------------------------+
| Sue Dubman (NCICB)                | Anne Ryan (DCP)                   |
|                                   |                                   |
| Brenda Duggan (NCICB)             | Frank Newby (CDISC)               |
|                                   |                                   |
| Christo Andonyadis (NCICB),       | Donna Marinucci (ECOG)            |
|                                   |                                   |
| Mary Jo Deering Ph. D (NCICB)     | Rachel Carle (Biotechnology       |
|                                   | Industry Organization, BIO)       |
| Julie Evans (CDISC)               |                                   |
|                                   | Pat Skarulis (Memorial Sloan      |
| Kamal Narang (CTIS)               | Kettering)                        |
|                                   |                                   |
| Kim Johnson (Duke)                | Jo Anne Zujewski (CTEP)           |
|                                   |                                   |
| Norman Goldbarb (First Clinical   | Diana McKenzie (Amgen)            |
| Research)                         |                                   |
|                                   | Joyce Niland (COH)                |
| Edmond Versroete (BIO)            |                                   |
|                                   | Betsy Fallen (Merk)               |
| Deborah Collyar (Patient          |                                   |
| Advocate)                         | Guy Tallent (SIG/ SAFE)           |
|                                   |                                   |
| George Redmond (CTEP)             | Mitch Hadley (SIG)                |
|                                   |                                   |
| Sharon Elcombe (Mayo Clinic)      | R. Mark Adams (Booz Allen)        |
|                                   |                                   |
| Beverly Meadows (DCP)             | Patrice Clark (Booz Allen)        |
|                                   |                                   |
| Dianne Paul (Patient Advocate)    | Kevin Vigilante (Booz Allen)      |
|                                   |                                   |
| Chuck Jaffe (SAIC)                | Chalk Dawson (Booz Allen)         |
|                                   |                                   |
| Troy Budd (CTEP)                  | Meg Gronvall (Booz Allen)         |
|                                   |                                   |
| Gary Secrest, (J&J/SAFE)          |                                   |
+-----------------------------------+-----------------------------------+

Meeting Materials Distributed:

+-----------------------------------------------------------------------+
| -   CRIX Face-to-Face Briefing (August 31^st^)                        |
|                                                                       |
| -   *CRIX Update Briefing (August 30^th^)*                            |
|                                                                       |
| -   *CRIX Steering Committee Agenda (August 30, 2005)*                |
+-----------------------------------------------------------------------+

The CRIX Face-to-Face briefing has been updated to reflect summary
discussion on the workshops and next steps. The updated document is
attached as part of these meeting minutes.

+--------------+-------------------------------------------------------+
| **Agenda     | **Summary of Discussion**                             |
| Topic**      |                                                       |
+==============+=======================================================+
| ***Update on | -   Sue Dubman presented a briefing (attached) to     |
| CRIX         |     update the Steering Committee on CRIX             |
| In           |     initiatives. Overall, substantial progress has    |
| itiatives*** |     been made.                                        |
|              |                                                       |
|              | -   Global investigator registry for commonly         |
|              |     used/referenced data. There are approximately     |
|              |     50,000 NCI investigators who need to be           |
|              |     credentialed. NCI is finalizing paperwork to make |
|              |     this happen.                                      |
|              |                                                       |
|              | -   The testing of SAFE as part of Firebird project   |
|              |     is going well. Need to workout some operational   |
|              |     issues with the Centers. For example, a number of |
|              |     academic researchers lock down their computers so |
|              |     no USB port to plug into which doesn't allow for  |
|              |     SAFE access, or nailing down the processes for    |
|              |     ordering new cards when the original card is      |
|              |     lost.                                             |
|              |                                                       |
|              | -   NCICB is working with FDA and IBM to develop a    |
|              |     clinical trials data warehouse pilot using the    |
|              |     JANUS model. All regulatory clinical data, animal |
|              |     toxicology data, analysis plan and protocol data  |
|              |     is included. Pilot only includes implementation   |
|              |     of existing Janus data model defined under IBM    |
|              |     CRADA w/ FDA.                                     |
|              |                                                       |
|              | -   Working on establishing a collaborative research  |
|              |     form to get away from unstructured text and into  |
|              |     structured data to allow analysis of data in a    |
|              |     common format with common meaning and ensure      |
|              |     integrity and consistency of information.This is  |
|              |     a great benefit to Pharma and other sponsors. The |
|              |     ability to look across trials to get/share        |
|              |     information potentially reduces number of people  |
|              |     who have to be on Phase 3 trial. From NCI         |
|              |     perspective we want to extend this beyond         |
|              |     regulatory data to getting spontaneous reports.   |
+--------------+-------------------------------------------------------+
| ***CRIX      | -   Kevin Vigilante presented an update on the CRIX   |
| Operational  |     Operational Framework. Two central focus areas    |
| Framework*** |     were discussed:                                   |
|              |                                                       |
|              |     -   CRIX Governance Mode                          |
|              |                                                       |
|              |     -   Firebird                                      |
|              |                                                       |
|              | -   Early emphasis is on developing a Firebird        |
|              |     business case that is self sustaining. Focusing   |
|              |     on Firebird first, maximizes the opportunities    |
|              |     for success and moving CRIX forward. Emphasis     |
|              |     needs to be placed on getting Firebird going and  |
|              |     learning from our mistakes for future CRIX        |
|              |     components.                                       |
|              |                                                       |
|              | -   Guy Tallent presented an overview of how the      |
|              |     group will organize to address CRIX strategic     |
|              |     milestones identified in the briefing.            |
|              |                                                       |
|              | -   Details on the CRIX Operational Framework is      |
|              |     contained in the updated CRIX face-to-face        |
|              |     briefing from August 31, 2005.                    |
+--------------+-------------------------------------------------------+
| ***Firebird  | -   Chalk Dawson presented a summary results for the  |
| Stakeholder  |     Firebird Stakeholder Analysis conducted by the    |
| Analysis     |     former CRIX Business Modeling Group. The analysis |
| Results***   |     focused on identifying:                           |
|              |                                                       |
|              |     -   Who benefits most from Firebird use?          |
|              |                                                       |
|              |     -   Who is most willing to pay for Firebird use?  |
|              |                                                       |
|              | -   The results showed that NCI (invest in launch &   |
|              |     incubation), Bio-Pharma (Big/Small Pharma), and   |
|              |     Regulators (e.g., FDA) are the stakeholders who   |
|              |     benefit the most **[and]{.underline}** are most   |
|              |     willing to pay for Firebird; while the patient    |
|              |     and investigators are the groups who benefit the  |
|              |     least and are least likely to pay for Firebird.   |
|              |                                                       |
|              |     **[The questions/ comments:]{.underline}**        |
|              |                                                       |
|              | -   Can we find ways for Firebird to be of more value |
|              |     to those with low or mod.. benefit?               |
|              |                                                       |
|              | -   Need to add providers/ insurance to the analysis. |
|              |                                                       |
|              | -   Need to do cost analysis ongoing cost for hosting |
|              |     etc. close to 1M. \$100 for SAFE Credential.&     |
|              |     \$50 for maintenance.                             |
|              |                                                       |
|              | -   Will States kick in? It may save states \$.       |
|              |                                                       |
|              | -   Model may shift over time based on success and    |
|              |     benefit to stakeholders. Value prop will increase |
|              |     for different stakeholders as modules are added.  |
|              |                                                       |
|              | -   Non-profit vs for profit models. How to move the  |
|              |     business model forward. The visa model or the     |
|              |     communications model?                             |
+--------------+-------------------------------------------------------+
| ***CRIX      | -   *Summary and key points from the workshop are     |
| Governance   |     included in the update August 31 CRIX             |
| Workshop***  |     face-to-Face Briefing*                            |
+--------------+-------------------------------------------------------+
| ***Firebird  | -   *Summary and key points from the workshop are     |
| Operations   |     included in the update August 31 CRIX             |
| Workshop***  |     face-to-Face Briefing*                            |
+--------------+-------------------------------------------------------+
| ***Next      | -   Develop a Project Plan that defines the           |
| Steps***     |     activities needed to accomplish the CRIX          |
|              |     milestones over the next 6 months                 |
|              |                                                       |
|              | -   Identify leads for each work stream               |
|              |                                                       |
|              |     -   Support leads                                 |
|              |                                                       |
|              |     -   Industry leads                                |
|              |                                                       |
|              | -   Identify operating norms for the work streams     |
|              |                                                       |
|              | -   Setup a listserv for the CRIX steering committee  |
|              |                                                       |
|              | -   Plan future meetings approximately every six      |
|              |     weeks                                             |
+--------------+-------------------------------------------------------+

**[ATTACHMENT A: AGENDA]{.underline}**

**Location: UCSF, Rock Hall Auditorium, 1550 4th Street, Room 102**

**Teleconference Number: 1-866-815-8292, pass code:  706245**

Meeting Host: Sue Dubman

Attendees:

  ------------------------ -------------------- -------------------------
  Christo Andonyadis,      Mark Adams, Booz     **Dialing-in/Webcast:**
  NCICB                    Allen                

  Sue Dubman, NCICB        Patrice Clark, Booz  Frank Newby, CDISC
                           Allen                

  Troy Budd, CTEP          Chalk Dawson, Booz   Sharon Elcombe, Mayo
                           Allen                Clinic

  Deborah Collyar, Patient Kevin Vigilante,     Betsy Fallen, Merck
  Advocate                 Booz Allen           

  Mary Jo Deering Ph. D,   Guy Tallent,         Kim Johnson, Duke
  NCICB                    SIG/SAFE             University

  Brenda Duggan, NCICB                          Donna Marinucci, ECOG

  Norman Goldfarb, First                        Beverly Meadows, DCP
  Clinical Research                             

  Diana McKenzie, Amgen/                        Rachel Carle,
  CTWG Industry Rep                             Biotechnology Industry
                                                Organization (BIO)

  Kamal Narang, CTIS                            Dianne Paul, Patient
                                                Advocate

  Joyce Niland, COH                             Gary Secrest, J&J/SAFE

  George Redmond, CTEP                          

  Pat Skarulis, Memorial                        
  Sloan Kettering                               

  Edmund Verstraete,                            
  Biotechnology Industry                        
  Organization (BIO)                            

  Jo Anne Zujewski, CCR                         
  ------------------------ -------------------- -------------------------

+--------------+-------------------------------+-----------------------+
| 9:00 -- 9:15 | Welcome                       | Sue Dubman            |
+--------------+-------------------------------+-----------------------+
| 9:15 -- 9:45 | Update on CRIX Initiatives    | Sue Dubman            |
|              |                               |                       |
|              | -   Firebird                  |                       |
|              |                               |                       |
|              | -   Janus/CRIX Pilot          |                       |
+--------------+-------------------------------+-----------------------+
| 9:45 --      | CRIX Operational Framework    | Sue Dubman/ Guy       |
| 10:45        |                               | Tallent / Kevin       |
|              | Driving CRIX forward - CRIX   | Vigilante             |
|              | Key Deliverables,             |                       |
|              | Dependencies, Work streams    |                       |
|              | and Priorities                |                       |
+--------------+-------------------------------+-----------------------+
| 10:45 --     | Firebird -- Stakeholder       | Chalk Dawson          |
| 11:00        | Analysis Results              |                       |
+--------------+-------------------------------+-----------------------+
| 11:00 --     | Workshop Overview/            | Patrice Clark         |
| 11:15        | Instructions                  |                       |
+--------------+-------------------------------+-----------------------+
| 11:15 --     | **Lunch Break**               |                       |
| 12:15        |                               |                       |
+--------------+-------------------------------+-----------------------+
| 12:15 --     | Workshops                     | Facilitators:         |
| 1:45         |                               |                       |
|              | -   Workshop A: CRIX          | Guy Tallent /Mary Jo  |
|              |     Governance Structure      | Deering/ Chalk Dawson |
|              |                               |                       |
|              | -   Workshop B: Firebird      | Sue Dubman/ Kevin     |
|              |     Implementation Analysis   | Viligante/ Patrice    |
|              |                               | Clark                 |
|              |     -   Business Model -- who |                       |
|              |         will pay for Firebird |                       |
|              |         use                   |                       |
|              |                               |                       |
|              |     -   Operational Model     |                       |
|              |         Analysis -- who will  |                       |
|              |         host Firebird         |                       |
+--------------+-------------------------------+-----------------------+
| 1:45 -- 2:45 | Workshop Feedback/Summary     | Workshop Spokesman    |
+--------------+-------------------------------+-----------------------+
| 2:45 -- 3:00 | Summary of Next Steps and     | Sue Dubman            |
|              | Wrap-up                       |                       |
+--------------+-------------------------------+-----------------------+