Skip to end of metadata
Go to start of metadata

Chair:  Hugh

Scribe:   Smita


See consolidated list

Agenda Topics

Agenda Item

Meeting Minutes from Discussion

Decision Link(if not child)

Approve minutes from April 21st

Approved by general consent


Draft agenda
  • Reviewed the draft agenda
  • Virtual WGM will run like a F2F meeting – same  Quarter time slots and on Easter Time (ET)
  • No update for BRIDG model

Device Related Issues - Andy Iverson

FHIR-26869 - Getting issue details... STATUS

Future consideration

FHIR-26866 - Getting issue details... STATUS   FHIR-26867 - Getting issue details... STATUS   FHIR-26868 - Getting issue details... STATUS

  • 26869 — Parked for now until we discuss it with the Consent resource owners.
  • Action Item – Hugh to add Jira tracker item for Consent resource
  • Action item - Andy to update ticket

Regulated Product Jira Issues - Rik Smithies

FHIR-26543 - Getting issue details... STATUS

FHIR-26570 - Getting issue details... STATUS

FHIR-26670 - Getting issue details... STATUS

FHIR-26669 - Getting issue details... STATUS

  • 26543 - Rik Proposed the motion, Catherine Seconded – Approved - 19,0,0
  • Remaining items postponed

Regulatory related JIRA tickets - Peter Bomberg

FHIR-26859 - Expand the allowed values in the Procedure.subject list

FHIR-26860 - Add RegulatedAuthorization to the CodeableReference list in Procedure.reason.Reference.

FHIR-26861 - Usage question relating to basedOn and partOf

FHIR-26862 - statusDate is missing 







Adverse Event Resource

Clinical Adverse event profile event profile

  • Review examples
  • Robinette presented the CIMBTR Adverse Event process
  • This is the CIMBTR use case to consider during development of the AE Profile for research

  • Rhonda F from CDISC provided information on the new CDISC to FHIR mapping effort
  • Will leverage all the mappings that have been completed on other projects
  • Initial focus will be on seven SDTM domains - Adverse Events (AE), AE Medication, Concomitant Medications (CM), Demographics (DM), Vital Signs (VS), Medical History (MH), Procedure (PR)
  • Plan to ballot the initial mappings in Sep 2020 HL7 ballot and simultaneously thru CDISC
  • Will be submitting PSS to BRR&R soon – Consider using the new PSS-lite. 
  • Action Item – Rhonda to send email to Hugh to learn more about PSS-lite

Next agenda topics

Will also discuss the agenda for the virtual WGM

Action items