# Presentation: 100777

## Teleconference/Web cast
Thursday, September 29, 2005

**Thursday, September 29, 2005**

**CRIX ***STEERING COMMITTEE MEETING*

## AGENDA 

**Welcome/Introductions**
**August 31****st**** Meeting Minutes Review/Approval**
**Briefing on CTWG Initiatives**
**CRIX Work Stream Overview (leads, participants, General Operating Procedures/norms)**
**CRIX Business Plan Template**
**Firebird Business Case Template **
**Plan/Schedule to develop Plans**
**Next Steps and Wrap-up**

## Update on CTWG Efforts

- 22 CTWG initiatives focused on restructuring the cancer clinical trials process
- 3-5 year effort
- Initiatives are focused around five common themes
- Coordination
- Prioritization/scientific quality
- Standardization
- Operational Efficiency
- Enterprise-wide
- NCICB has developed a proposed implementation plan for 3 initiatives to be presented  to CTWG on Oct. 3rd
- Developing NCI-wide clinical trials database
- Promoting caBIGTM interoperability
- Creating a standardized CRF

## Slide 4

## Work Stream Leads and Participants

| CRIX Governance Structure | Firebird Operations |
| --- | --- |
| Facilitators: TBD/ Guy Tallent | Leads: Edmund Verstraete / Kevin Vigilante |
| Brenda Duggan, NCICB | Christo Andonyadis, NCICB |
| George Redmond, CTEP | Sharon Elcombe, Mayo Clinic |
| Deborah Collyar, Patient Advocate | Bill Rosen, PhRMA Electronic Regulatory Submissions (ERS) |
| Mary Jo Deering Ph. D, NCICB | John Speakman, Memorial Sloan Kettering |
| Kim Johnson, Duke University | Donna Marinucci, ECOG |
| Norman Goldfarb, First Clinical Research | Beverly Meadows, DCP |
| Rachel Carle, BIO | Edmund Verstraete, BIO |
| Joyce Niland, COH | Dianne Paul, Patient Advocate |
| Diana McKenzie, Amgen/ CTWG Industry Rep | Gary Secrest, J&J/SAFE |
| Pat Skarulis, Memorial Sloan Kettering | Kamal Narang, CTIS |
| Betsy Fallen, Merck | Mike Montello, NCICB CTEP |
| Rebecca Kush, CDISC | Bill Barrick, NCI |
| John Mestler, Proctor & Gamble | Tom Scarnecchia, IMPACC |
| Troy Budd, CTEP | Frank Newby, CDISC |
| George Redmond, CTEP | Charlie Mead, Oracle |

## Proposed Steering Committee Meeting Dates – approx. every 6 weeks

| Meeting Title | Meeting Date | Duration | Type/Location |
| --- | --- | --- | --- |
| CRIX Steering Committee Meeting - Nov. 2005 | Tue 11/15/05 | 1d | Face-to-Face (DC Area) |
| CRIX Steering Committee Meeting - Dec. 2005 | Fri 12/16/05 | 2h | Telecon/Web cast |
| CRIX Steering Committee Meeting - Jan. 2006 | Mon 1/9/06 | 1d | Face-to-Face (west coast) |
| CRIX Steering Committee Meeting - Feb. 2006 | Tue 2/21/06 | 2h | Telecon/Web cast |
| CRIX Steering Committee Meeting - Mar. 2006 | Tue 3/28/06 | 1d | Face-to-Face (mid-west) |
| CRIX Steering Committee Meeting - May 2006 | Mon 5/8/06 | 1d | Telecon/Web cast |
| CRIX Steering Committee Meeting - Jun. 2006 | Mon 6/26/06 | 1d | TBD |
| CRIX Steering Committee Meeting - Aug. 2006 | Mon 8/21/06 | 1d | TBD |
| CRIX Steering Committee Meeting - Sep. 2006 | Fri 9/29/06 | 1d | TBD |

## Steering Committee Meeting Structure

_**Web cast Format (2 hours):**_
- Welcome/Introductions – 5 min
- Review/ approval of last meeting’s minutes – 5 min
- Update on related efforts/initiatives  – 15 min
- Discussion Topic 1 – 30 min
- Discussion Topic 2 – 30 min
- Discussion Topic 3 – 30 min
- Summary of Actions and Wrap up –5 min

## Steering Committee Meeting Structure

_**Face-to-Face Format (All day, 6 hours):**_
- Welcome/Introductions – 5 min
- Review/ approval of last meeting’s minutes – 5 min
- Update on related efforts/initiatives  – 30-45 min
- Discussion Topic 1 – 30 min
- Discussion Topic 2 – 30 min
- Discussion Topic 3 – 30 min
- Lunch Break – 30 minutes
- Workshops – 2 hours
- Workshop results – 1 hour
- Summary of Actions and Wrap up –5 min

## Proposed Review Process	

- Process assumes Steering Committee meetings every 6 wks
- Work Stream to present/walk-through
- Draft business plan detail sections available as take-aways for Steering Committee review
- Steering Committee comments due to delivery team within one week
- 2-3 Work Stream meetings (via telecon) to work  through  details between steering  committee meeting
- Comments incorporated and re-distributed 2 days prior to next steering committee meeting
- Target approval at Jan. 9th steering committee meeting

**Notes:**
Interactions with FDA use different security models for different types of transactions
INDs, NDAs, Safety updates are all “secure” but use different technology
High implementation cost

The industry is rife with numerous failed attempts at delivering a technology solution for improving interactions
This is not a technology problem e.g PKI

Our goal was to find and leverage an existing identity trust model to accelerate FDA’s implementation of electronic transactions

## CRIX Business Plan Template

***Please Refer to Word Document***

- Illustrative

## Firebird Business Case Template

***Please Refer to Word Document***

- Illustrative

## Plan/Schedule to Develop CRIX & Firebird Plans