agendas @ 2022 Autumn
Conference Calls and Minutes
BR&R at present has 2 weekly conference calls and 1 bi-weekly call:
- Every Tuesday from 16:00-17:00 Eastern Time (Typical Agenda: BR&R Admin; ResearchStudy & ResearchSite resource related discussions)
- Every 2nd Wednesday from 13:00-14:00 Eastern Time (Typical Agenda: PQ/CMC Discussions)
- Every Thursday from 12:00-13:00 Eastern Time. (Typical Agenda: Structured Protocol)
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):
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.
- Vulcan Real World Data Project - Every Tuesday from 11:00-12:00 Eastern Time
- Vulcan Schedule of Activities Project - Every Wednesday from 11:00-12:00 Eastern Time
- Vulcan Adverse Events Project - Every Thursday from 11:00-12:00 Eastern Time
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).