BRIDG: a domain information model for translational and clinical protocol-driven research.
BACKGROUND
It is critical to integrate and analyze data from biological, translational, and clinical studies with data from health systems; however, electronic artifacts are stored in thousands of disparate systems that are often unable to readily exchange data.


OBJECTIVE
To facilitate meaningful data exchange, a model that presents a common understanding of biomedical research concepts and their relationships with health care semantics is required. The Biomedical Research Integrated Domain Group (BRIDG) domain information model fulfills this need. Software systems created from BRIDG have shared meaning "baked in," enabling interoperability among disparate systems. For nearly 10 years, the Clinical Data Standards Interchange Consortium, the National Cancer Institute, the US Food and Drug Administration, and Health Level 7 International have been key stakeholders in developing BRIDG.


METHODS
BRIDG is an open-source Unified Modeling Language-class model developed through use cases and harmonization with other models.


RESULTS
With its 4+ releases, BRIDG includes clinical and now translational research concepts in its Common, Protocol Representation, Study Conduct, Adverse Events, Regulatory, Statistical Analysis, Experiment, Biospecimen, and Molecular Biology subdomains.


CONCLUSIONS
The model is a Clinical Data Standards Interchange Consortium, Health Level 7 International, and International Standards Organization standard that has been utilized in national and international standards-based software development projects. It will continue to mature and evolve in the areas of clinical imaging, pathology, ontology, and vocabulary support. BRIDG 4.1.1 and prior releases are freely available at https://bridgmodel.nci.nih.gov .
Clinical Data Interchange Standards Consortium, Austin, TX, USA.|Dan L. Duncan Cancer Center, Baylor College of Medicine, Houston, TX, USA.
Lauren B
LB
Becnel
Samvit Solutions LLC, Reston, VA, USA.
Smita
S
Hastak
Samvit Solutions LLC, Reston, VA, USA.
Wendy
W
Ver Hoef
National Marrow Donor Program, Minneapolis, MN, USA.
Robert P
RP
Milius
Food and Drug Administration Office of Strategic Programs, Silver Spring, MD, USA.
MaryAnn
M
Slack
Clinical Data Interchange Standards Consortium, Austin, TX, USA.
Diane
D
Wold
Computer Network Architects Inc. and ISO/TC 215 Health Informatics, Rockville, MD, USA.
Michael L
ML
Glickman
Food and Drug Administration Office of Strategic Programs, Silver Spring, MD, USA.
Boris
B
Brodsky
HL7 (Health Level 7 International), Ann Arbor, MI, USA.
Charles
C
Jaffe
Clinical Data Interchange Standards Consortium, Austin, TX, USA.
Rebecca
R
Kush
National Cancer Institute, Rockville, MD, USA.
Edward
E
Helton
D035843:Biomedical Research; D000073892:Health Information Interoperability / Q000592:standards*; D000075403:Semantic Web / Q000592:standards; D012984:Software; D009626:Terminology as Topic
clinical trials; data modeling; data sharing; pharmacogenetics; translational medical research