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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 23rd

Approved by general consent

10 min

FHIR to CDASH/SDTM. PSS Rhonda Facile

Further review

Went over the CDISC FHIR mapping timeline, by CDASH domain.

Proposed to have 10-min reviewed at the BR&R meetings upon completion of each stage.

Will update to reflect the general mapping process and timeline in terms of ballot preparation in the PSS.

CDISC will submit the completed CDISC-HL7 shared IP agreement.

5 minsIRB NIB

No further comments provided.

Marti motioned to approve, Catherine second, 13-0-0, approved.


ResearchSubject Issue:

 Consent resource for ResearchSubject

aka ResearchSubject is not an entity!

ResearchSubject is about representation of the individual in a study - not the info about the individual, which is captured in the Patient (or RelatedPerson) resource, including patient's consent. (E.g. the individual could participate in multiple studies, i.e. having multiple ResearchSubject instances for a single person.) Similar to the participation concept in V3.

However, not all subjects are patients (could be samples, or devices), but those shouldn't be using the ResearchSubject resource (although they would be identified in the ResearchStudy resource). Some subjects (e.g. animal herds in veterinary medicine) would be using the Group resource, which in turn would reference the individual participants.

The definition of Patient, potentially not alignment with its meaning in the research context, should be clarified in the documentation, starting with expanding the definition of the Patient resource IG. Peter will submit tickets to address the above.

From the educational perspective, it may help to have a separate module for research, providing an introduction of how the related concepts are used in research context. May include a conceptual model of clinical research, including pointers to the respective FHIR resources. 

Identifiers for anonymized patients should be consistent with the instructions in the security section. Different instances may contain different amount of information about the patient. Will rely on implementation-specific guide for the instruction of what needs to be anonymized, based on the protocol. 

ResearchSubject has a bi-directional link to Consent, since there is many-to-many relationship between subjects and studies, but it may be better to point the link from Consent to the ResearchStudy rather than back to ResearchSubject.    

ITAJira issues (Peter Bomberg)

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