agendas @ 2022 Autumn
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Conference Calls and MinutesBR&R at present has 2 weekly conference calls and 1 bi-weekly call:
Note: Agenda's for each of these calls changes from time to time to support WG priorities. To join a call click on the following link: https://hl7-org.zoom.us/j/95147253604 Meeting ID: 951 4725 3604 You can download and import the calendar files to your calendar system (outlook is below but you have to add recurrence, for other formats go to the HL7 Conference call centre): Tuesday.ics Wednesday.ics Thursday.ics To get a local phone number go to: https://zoom.us/u/aeyKKVpETd If you ever need it this is the Meeting ID: 951 4725 3604 There is a Tip Sheet for Zoom here All active participants and other interested individuals are invited to join us for this call. Conference call agendas and minutes are posted here on Confluence - see the tree on the left of the page The Vulcan Accelerator also holds calls that are relevant to the BR&R Work Group. Please check the HL7 Conference Call Center for the details of these Vulcan calls.
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Work Products and Contributions to HL7 Processes
The BR&R performs the bulk of its work through projects with a clear line of sight to its scope. Examples include BRIDG (domain analysis model supporting research) and RPS (exchange message supporting medical product application submissions to regulators).
This Work Group will facilitate the development of common standards and the maintenance and enhancement of the research-focused domain analysis model for clinical research information management across a variety of organizations, including national and international government agencies and regulatory bodies, private researchers and research organizations, sponsored research, CROs and other interested entities. A shared semantic view is essential if the clinical research community, both for itself and as part of the larger Healthcare and life sciences communities, is to achieve computable semantic interoperability.
The BR&R will seek to assure that related or supportive standards produced by other HL7 groups are robust enough to accommodate their use in regulated clinical research through participation as appropriate, including ballots. The group will also monitor information interchange standards developed outside of HL7, and attempt harmonization of information content and representation of such standards with the HL7 content and representation.
The BR&R’s charge includes the maintenance of BR&R-produced standards until their useful life has been exceeded, either through discontinuance of use or through supercession by later versions of the standard. The portfolio of standards will be reviewed annually for active use, obsolescence, and potential need for change. When a standard is identified for withdrawal, the BR&R will make efforts to communicate to users or potential users of that standard well in advance of any withdrawal action.
The BR&R will develop specifications using the principles and language of the Services Aware Interoperability Framework (SAIF) Canonical Definition (CD) and the restrictions and specializations of the HL7 SAIF Implementation Guide (IG) to ensure traceability from conceptual to logical to implementable specifications.
The term “regulated” or “regulation” refers to human and animal medical products and foods regulation.
Formal Relationships with Other HL7 Groups
Clinical Genomics; Clinical Interoperability Council; Clinical Quality Information; Electronic Health Record; Health Care Devices; Orders and Observations; Patient Care; Patient Safety; Pharmacy; Public Health and Structured Documents
Formal Relationships with Groups Outside of HL7
The BR&R maintains liaison relationships with appropriate national and international standard bodies subject to the approval of the HL7 Board, including at minimum CDISC and ISO TC 215 (and by reference, CEN TC 251).
Co-Chairs
Maryam Garza
UAMS- University of Arkansas for Medical Sciences
mygarza@uams.edu
Smita Hastak
Samvit Solutions
shastak@samvit-solutions.com
Jean Duteau
Duteau Design
Jean-Henri Duteau' <jean@duteaudesign.com