Biomedical Research and Regulation (BR&R)

Welcome Welcome to the Biomedical Research and Regulation (BR&R) Work Group Wiki Site. Leadership Co-Chair: Boris Brodsky; +1 301-796-5179, brodsky@fda.hhs.gov Co-Chair: Edward Helton; +1 301-480-4290, heltone2@mail.nih.gov Co-Chair: John Kiser; +1 847-937-3725, john.kiser@abbvie.com Co-Chair: Vada Perkins; +1 2028102610, vada@idglobally.com Project Facilitator: Mead Walker Publishing Facilitator: Myron Finseth Vocab Facilitator: Julie James Conference Calls and Minutes Dates: Time: Phone Number: Participant Passcode: Link to BR&R WG minutes on hl7.org Mission The BR&R workgroup areas of interest encompass clinical and translational research, both regulated and non-regulated, and the subsequent regulatory submissions and information exchanges to bring new products to market and to ensure safe use throughout the product lifecycle. BR&R creates and promotes standards to facilitate biomedical research and any subsequent regulatory evaluation of the safety, efficacy and quality of medical products that may arise from research. Charter The basic charter of the Orders and Observation work group is to continue to support the ongoing development of Version 2.x and ensuring that equivalent functionality is present in HL7 Version 3.0. 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 supersession 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 Emergency Care FHIR Health Care Devices Orders and Observations Patient Care Patient Safety Pharmacy Public Health and Emergency Response 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).