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Chair: Hugh Glover

Scribe:  Myron Finseth

Attendees

Present

(y/n)

Name

Affiliation


Panagotis TelonisEMA
xBoris BrodskyFDA
xSmita HastakSamvit Solutions
xRik SmithiesNProgram
xBron KislerNIH
xVaishnavi Rao

Scott GordonFDA
xBill Friggleself

Ron FitzmartinFDA

Wendy Ver HoefSamvit Solutions

Robinette RennerNMDP
xMead Walkerself
xDragonself
xJulie EvansSamvit Solutions
xNorman GregoryFDA
xJane PollackNMDP
xCatherine Hosage NormanModule 3 Solution

Andy IversonMedtronic

Amy NordoPfizer

Robin TaylorNIH
xAbdullah RafiqiASAC inc
xGayathri JayawardenaASAC inc
xBecky AnglesNCI

Christi DennyLilly

John StammEpic

Katheen ConnorVA
xRichard BallewNIH

Craig Anderson

Mike FlaniganCarradora
xGary SanerReed Technology

Minutes Approved as Presented 

This is to approve minutes via general consent. "You have received the minutes. Are there any corrections to the minutes? (pause) Hearing none, if there are no objections, the minutes are approved as printed."


Agenda Topics

Agenda Outline

Agenda Item

Meeting Minutes from Discussion

Decision Link(if not child)

Management

Minutes Approval



Projects

PQ/CMC PSS

Rik, Smita:

  • We have about a year before IDMP has a sense of urgency.
  • Might ballot IDMP in January. Need to get the resources at a higher maturity level. Now at Level one.
  • Let Rik know, when your group finishes modeling resources.
  • Rik went through the IDMP proposal to the FMG.
  • Group voted to approve the proposal:
  • Catherine proposed to approve; Smita second to approve; no one against; no comments.


sIRB




1426 Women’s Health Technology Coordinated Registry Network (CRN)

No updates (Dragon)



1425 CDISC Lab Semantics in FIR




1424 Common Data Model Harmonization (CDMH) - FHIR Implementation Guide




1416 Exploration of FHIR resources to support of IDMP 11238/19844 Substances Standard and Technical Specification




BRIDG Model Update




eSource



FHIR

Tracker items




Continuing review of ResearchStudy and ResearchSubject to move to higher maturity level.



Other Items




Management Next agenda

Supporting Documents

Outline Reference

Supporting Document




Action items

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