RCRIM Working Group Meeting Wednesday Q1 17 September 2008 1.

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Presentation transcript:

RCRIM Working Group Meeting Wednesday Q1 17 September

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

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 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

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 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 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