The term "BRIDG Project" (or sometimes simply "BRIDG") is used to refer to the content of the model, as well as the organizational governance, model management, maintenance, and the evolution processes defined and executed by various BRIDG participants. From a governance perspective, there are several groups involved in overseeing the project or managing the ongoing evolution of the BRIDG Model.
BRIDG Steering Committee
The BRIDG Steering Committee (formerly called Board of Directors (BoD)) was established to provide the five stakeholder organizations (CDISC, FDA, HL7, ISO and NCI) with a semi-formal mechanism to prioritize BRIDG activities and to direct and monitor the content, management, maintenance, support, and evolution of the BRIDG Model. This governance body also has members from organizations that represent the BRIDG user community.
The BRIDG Steering Committee consists of appointed and elected members. Each founding stakeholder appoints one member who serves at the discretion of that stakeholder. The elected members are chosen from nominees during election, with the total number of elected and appointed members being up to eleven; additional members may be included at the discretion of the Steering Committee. Operationally, harmonization priority decisions are made based on consideration of a number of factors including stakeholder balance, overall semantic content balance of the BRIDG Model, the state of the project’s “harmonizable artifacts” and an overview of the entire project execution space to make sure complimentary or possibly redundant project content is scheduled concurrently or sequentially whenever possible.
Meeting notes from the Steering Committee meetings can be found here.
Steering Committee Members
|Mary Ann Slack||FDA|
*Names presented in alphabetical order
The BRIDG Modeling Team and the HL7 Biomedical Research and Regulation Work Group (BR&R WG)
Although the BRIDG Steering Committee defines the overall prioritization and scheduling decisions as to which content will be harmonized with the BRIDG Model when, the actual process of representing the semantic content from a given project in the BRIDG Model is the responsibility of the BRIDG modeling team. Members of the modeling team have experience and expertise in clinical trial content and process, standards development, and knowledge acquisition and representation (“modeling”). They are responsible for the specific decisions regarding how a given project’s concepts are represented in the BRIDG Model as a whole.
Specifically, each project brings to the modeling team its harmonizable artifacts, e.g. UML class and other types of diagrams documenting the project’s concepts and their metadata, as well as a draft mapping spreadsheet identifying the corresponding BRIDG semantics and any gaps or proposed new semantics needed to support the project. It is expected that the artifacts provided by the project have been vetted within its context or scope and that project team members will be available to participate in the process. The project’s submission is then analyzed by the modeling team in dialogue with project team members and sometimes also the WG to arrive at a consensus and shared understanding of the chosen representation of the project team’s semantics in the BRIDG Model. This likely includes changes to the BRIDG model and hopefully changes to the project’s model as well. This process is collectively referred to as ‘harmonization.’ The BRIDG Model is then balloted once a year and the WG has the additional opportunity to vet the model. The BRIDG Modeling Team is also tasked with the core day to day evolution of the BRIDG model, including ballot reconciliation, model maintenance, infrastructure management, education and training.
BRIDG Modeling Team Members
|Smita Hastak||(Samvit Solutions /NCI [C] /HL7 BR&R WG)|
|Wendy Ver Hoef||(Samvit Solutions /NCI [C] /HL7 BR&R WG)|
|Boris Brodsky||(FDA/HL7 BR&R WG)|
Several members of the extended clinical research community have supported and participated in BRIDG modeling or other aspects over the life of the project, contributing greatly to the project's success (in alphabetical order):
Christo Andonyadis (NCI)
Becky Angeles (ScenPro, Inc.)
Landon Bain (CDISC)
Ken Buetow, Ph.D. (NCI)
Jean-Henri Duteau (Duteau Consulting/NCI [C] /HL7)
Julie Evans (CDISC, Samvit Solutions)
Doug Fridsma (Univ. of Pittsburg/ASU)
Becky Kush, Ph.D. (CDISC)
Jonathan Levine (FDA)
Lloyd McKenzie (Gevity /NCI [C] /HL7)
Charlie Mead, M.D. M.S. (Booz Allen Hamilton, Inc./NCI)
Saurin Mehta (Novartis)
Mitra Rocca (FDA)
Steve Sandberg (Mayo Clinic)
John Speakman (NCI)
Diane Wold (GSK)
Mike Woodcock (Mayo Clinic)