1. RCRIM Working Group Meeting Wednesday Q1 17 September 2008 1

2. Wednesday Q1 Agenda Protocol Representation V1 Standard (Lisa) PRG and Clinical Trial Registry and Results discussion (Kris) BRIDG Update and Issues (Julie, Charlie) 2

3. BRIDG Update BRIDG 2.0 released June 2008 BRIDG BoD Call for Nominations User Group Meeting – January 2009 Building, Maintaining, and Evolving a Model of Shared Semantics -- The BRIDG Project: Lessons Learned and Next Steps 3

4. 4 What’s In Release 2.0? ProjectStakeholder Study Data Tabulation Model (SDTM)CDISC Regulated Product Submission (RPS)FDA/HL7 RCRIM Patient Study Calendar (PSC)NCI Trial Design Model (TDM)CDISC caXchange/LabHubNCI/HL7 RCRIM TC/CDISC Clinical Trial Object Model (CTOM)NCI Adverse EventsCDISC, NCI, FDA, Federal AE Task Force Cancer Central Clinical Patient Registry (C3PR) NCI Person / Organization (Player / Scoper)NCI

5. BRIDG Board of Directors 5 Appointed Members Charlie MeadNCI Armando OlivaFDA Dave Iberson-HurstCDISC Chuck JaffeHL7 At Large MembersTerm (Yrs) Christopher Chute2 Becky Kush3 John Speakman2 Christo Andonyadis1

6. 6 BRIDG THC NameAffiliation Charlie MeadNCI / Booz Allen Hamilton Steve SandbergNCI / Mayo Smita HastakNCI / Scenpro Wendy Ver HoefNCI / Scenpro Becky AngelesNCI / Scenpro Julie EvansCDISC Saurin MehtaCDISC / Novartis Jay LevineFDA

7. 7 What’s Coming After Release 2.0? ProjectHarmonization DateStakeholder Clinical Trial RegistryJune 2008CDISC / HL7 Protocol Abstraction – goes with CTRJune 2008NCI Protocol RepresentationCDISC / HL7 Structured Product LabelFDA CardiologyDuke Clinical Research TuberculosisDuke Clinical Research Statistical Analysis, including SAPLate 2008 / early 2009CDISC RPS Release 2End of 2008?FDA CDISC HL7 Message Project GapsLate 2008 / Early 2009?FDA PharmacogenomicsFDA/CDISC/HL7 Eligibility Criteria (EMR perspective)W3C Clinical Observation Interoperability