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Difference between revisions of "2018-02-27 BR&R Conf Call"

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===1. Minutes Approval===
 
===1. Minutes Approval===
 
* Meeting minutes, February 13, 2018 (MF)
 
* Meeting minutes, February 13, 2018 (MF)
  Motion: Jose Galvez
+
Motion: Jose Galvez
  Second: Julie Evans
+
Second: Julie Evans
  
 
* May HL7 Ballot:
 
* May HL7 Ballot:
  The FDA withdrew the SPL R9 and CPM R5 standards (supports PQ/CMC requirements)  
+
The FDA withdrew the SPL R9 and CPM R5 standards (supports PQ/CMC requirements)  
 
from the May ballot. There might be an opportunity to ballot SPL R9 and CPM R5 in  
 
from the May ballot. There might be an opportunity to ballot SPL R9 and CPM R5 in  
 
Sept 2018 or later.
 
Sept 2018 or later.

Revision as of 22:36, 27 February 2018

Attendees

  • Ed Helton (Co-Chair) xxx (Scribe)
  • Boris Brodsky (Co-Chair
  • Myron Finseth (Co-chair, Scribe)
  • Nagesh Basham
  • Julia Chen
  • Julie Evans
  • Bill Friggle
  • Jose Galvez
  • Smita Hastak
  • Catherine Hosage Norman
  • Ginny Hussong
  • Wendy Ver Hoef
  • Shifu Zhao
  • Norman Gregory
  • Robinette Renner
  • Ulrike Wagner
  • Jim Rogers
  • Gary Saner

Agenda Items and notes

1. Minutes Approval

  • Meeting minutes, February 13, 2018 (MF)

Motion: Jose Galvez Second: Julie Evans

  • May HL7 Ballot:

The FDA withdrew the SPL R9 and CPM R5 standards (supports PQ/CMC requirements) from the May ballot. There might be an opportunity to ballot SPL R9 and CPM R5 in Sept 2018 or later.

2. Action items handling

  •  ???

3. PSS Review and Approval

3.1 BRIDG PSS

  • BRIDG will be balloted on the May 2018 ballot. Planning to further develop the FDA Common Data Model.

3.2 SPL r9 (PQ/CMC) PSS

  • The SPL R9 and CPM R5 standard were removed from the May ballot cycle. These two standards could be submitted for the September ballot.

3.3 Patient Outcomes Reporting

4. FHIR

4.1 FHIR Tracker Items

  • Look at outstanding items

4.2 IDMP Related Models

  •  ???

4.3 Lab model in collaboration with TransCelerate

5. Action Item List

  • Nothing at this time

6. AOB

  •  ???