Timeboxing: AR - as required ITA - if time allows
Meeting Minutes from Discussion
Decision Link(if not child)
Call to order, Agenda and Approve minutes from June 30th
Approved by general consent
|5 min||sIRB NIB - IG Proposal|
After the NIB was submitted, the proposal was approved by FMG.
|5 min||CDISC 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.
Adverse Events - Jean Duteau
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||May be a better fit for FHIR Infrastructure.|
|AR||Jira issues (Peter Bomberg)|
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.
Next agenda topics
Expecting no meeting July 14th, formal cancellation forthcoming