The BRIDG Project: A Technical Report

Fridsma, Douglas B.; Evans, Julie; Hastak, Smita; Mead, Charles N.

doi:10.1197/jamia.m2556

Cited by 95 publications

(67 citation statements)

References 9 publications

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“…The dominant discussion forums for moving toward clinical research data standards that support applied uses are the Clinical Data Standards Interchange Consortium (CDISC) and the Regulated Clinical Research (RCRIM) Technical Committee of Health Level Seven (HL7). Compelling use-cases for shared clinical and research data drove the development of the BRIDG domain analysis model as a shared model to harmonize both sets of standards [17]. New and forthcoming pilot projects sponsored by HL7 and CDISC that demonstrate the use of common data elements and the BRIDG for specific therapeutic areas (e.g., cardiovascular, tuberculosis, and diabetes) should be monitored and explored as a source of standardized questions for rare disease registries [3,7,45].…”

Section: Data Standardsmentioning

confidence: 99%

Patient Registries: Utility, Validity and Inference

Richesson

Vehik

2010

Advances in Experimental Medicine and Biology

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Patient registries are essential tools for public health surveillance and research inquiry, and are a particularly important resource for understanding rare diseases. Registries provide consistent data for defined populations and can support the study of the distribution and determinants of various diseases. One advantage of registries is the ability to observe caseload and population characteristics over time, which might facilitate the evaluation of disease incidence, disease etiology, planning, operation and evaluation of services, evaluation of treatment patterns, and diagnostic classification. Any registry program must collect high quality data to be useful for its stated purpose. Registries can be developed for many different needs, and caution should be taken in interpreting registry data, which has inherent biases. We describe the methodological issues, limitations, and ideal features of registries to support various rare disease purposes. The future impact of registries on our understanding and interventions for rare diseases will depend upon technological and political solutions for global cooperation to achieve consistent data (via standards) and regulations for various registry applications.

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Section: Data Standardsmentioning

confidence: 99%

Patient Registries: Utility, Validity and Inference

Richesson

Vehik

2010

Advances in Experimental Medicine and Biology

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“…As noted previously in this chapter, numerous studies have identifi ed the dissemination or exchange of information between various research and operational settings as one of the most pressing issues contributing to such long research, development and implementation lifecycles [ 14 ]. A wide variety of BMI tools and methods have been developed that are intended to overcome these barriers, such as web-based communication and collaboration tools, knowledge representation standards and platforms, public data and literature registries/databases and associated query and reporting tools, and evidence-based practice tools such as guideline delivery systems and clinical decision support systems [ 4 , 7 , 16 , 28 ].…”

Section: Dissemination and Exchange Of Knowledge Generated Via Researmentioning

confidence: 98%

Driving Clinical and Translational Research Using Biomedical Informatics

Payne

Embí

2014

Health Informatics

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By the End of This Chapter, Readers Should Be Able to• Describe study types and designs commonly encountered in the clinical and translational research domain; • Understand the information needs of stakeholders involved in clinical and translational research, and how those needs can be satisfi ed using Biomedical Informatics theories and methods; • Understand how to critically evaluate study designs and information needs in order to optimize the adoption/adaptation of Biomedical Informatics tools or technologies; and • Synthesize the challenges and opportunities in the Biomedical Informatics domain as they pertain to clinical or translational research, and that may serve to inform new lines of basic and applied research and innovation.

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“…Also the joint effort carried out by BRIDG (Biomedical research Integrated Domain Group) [6] and caBig (cancer Biomedical Informatics Grid) [7], considers the domain of clinical trial on pharmaceutical products, focusing on the harmonization between HL7 messaging model and CIDSC data model.…”

Section: Standardization Initiativesmentioning

confidence: 99%

The HL7 RIM in the Design and Implementation of an Information System for Clinical Investigations on Medical Devices

Luzi

Contenti

Pecoraro

2010

IFIP Advances in Information and Communication Technology

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Abstract. The paper describes MEDIS (Medical Device Information System), a system developed to support the whole lifecycle of a Clinical Investigation (CI) for Medical Devices, providing details on the approach used in its development. MEDIS is a software system that collects and manages data and documents, exchanged between an applicant and the Italian National Competent Authority during all the phases of the business process, from the CI notification up to the submission of the final results. The development of the MEDIS Domain Analysis Model (DAM) following the HL7 v.3 methodology as well as the approach followed in the system implementation are discussed in relation to the business domain peculiarities.

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The BRIDG Project: A Technical Report

Cited by 95 publications

References 9 publications

Patient Registries: Utility, Validity and Inference

Patient Registries: Utility, Validity and Inference

Driving Clinical and Translational Research Using Biomedical Informatics

The HL7 RIM in the Design and Implementation of an Information System for Clinical Investigations on Medical Devices

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