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Agenda Topics

Timeboxing: AR - as required   ITA - if time allows

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Agenda Item

Meeting Minutes from Discussion

Decision Link(if not child)

10 min

Call to order, Agenda and Approve minutes from June 30th

Approved by general consent


5 minsIRB NIB - IG Proposal

After the NIB was submitted, the proposal was approved by FMG. 


5 minCDISC Lab Mapping rename

FMG has objected that "HL7 doesn’t currently have an agreement with CDISC so it isn’t appropriate to use CDISC in the name." Wasn't the original name, was proposed to disambiguate. CDISC considered the naming acceptable. 

New name proposed "Clinical research sponsor laboratory semantics in FHIR." Christi motioned to change the name, Amy second, no abstentions, no negatives, 19-0-0 approved. 


15 min

Adverse Events - Jean Duteau
FHIR Implementation Guide that provides a set of profiles for detection, validation, reporting, and ultimately recording/persisting Adverse Events associated with blood transfusions and vaccinations.

Project proposal:  

PSS-1656 - Getting issue details... STATUS  FHIR Implementation Guide for ICSR Submissions


Will change the name to limit the scope to blood transfusions and vaccinations. Scoping to the latest versions supporting FAERS (R2) and VAERS. Based on R4.

In the future, may be interested in expanding the scope to the full ICSR implementation. The present project does the full FAERS and VAERS mapping, but only tests for a subset of the codes.

BR&R confirm the interest in being the project sponsor. 

Have not taken to the Patient Care work group, to coordinate with the AE resource.

Vulcan SC has expressed interest in learning more about the project. May work on expanding the project beyond the stated use cases. 



5 min

Project proposal:

PSS-1657 - Getting issue details... STATUS  FAIRness for FHIR


May be a better fit for FHIR Infrastructure. 
ARJira issues (Peter Bomberg)

RegulatedAuthorization resource:

Need to define all contacts for each regulated authorization. 

Separate contacts are associated with submissions and licenses. 

Closing the issue with the recommendation to make a Health Canada specific extension for now. Peter made a motion, Rik second, no negatives, no abstentions, 17-0-0 approved.


ITAResearchSubject


Next agenda topics

Expecting no meeting July 14th, formal cancellation forthcoming


Action items