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

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===3. PSS Review and Approval===
 
===3. PSS Review and Approval===
  
====3.1 BRIDG PSS====
+
====3.1 Patient Reported Outcomes PSS====
* BRIDG will be balloted on the May 2018 ballot. Planning to further develop the FDA Common Data Model.
+
* Dragon motioned to approve the PSS. Jose second the motion. BRIDG will be balloted on the May 2018 ballot. Planning to further develop the FDA Common Data Model. Bill Friggle asked if someone from BR&R could follow the Patient-reported outcomes project and report to the WG progress or helpful notes. Ed agreed that would be a good idea. Bill will be the person following this project.
  
 
====3.2 SPL r9 (PQ/CMC) PSS====
 
====3.2 SPL r9 (PQ/CMC) PSS====

Revision as of 22:58, 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

2. 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.

  • BRIDG will be on the May ballot and will include the Common Data Model.

2. Action items handling

  •  ???

3. PSS Review and Approval

3.1 Patient Reported Outcomes PSS

  • Dragon motioned to approve the PSS. Jose second the motion. BRIDG will be balloted on the May 2018 ballot. Planning to further develop the FDA Common Data Model. Bill Friggle asked if someone from BR&R could follow the Patient-reported outcomes project and report to the WG progress or helpful notes. Ed agreed that would be a good idea. Bill will be the person following this project.

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

  •  ???