Glossary

Abstract Data Typessearch for term

HL7 Standard: Generally refers to the HL7 Datatype R2 specification, which is related to the ISO 21090 standard.

ADaMsearch for term

CDISC Project: Analysis Data Model.

AEsearch for term

Adverse event.

AIMsearch for term

Annotation and Image Markup - an NCI Imaging Project.

Associationsearch for term

A relationship between classes within a UML model.

Attributesearch for term

A characteristic or property of a class within a UML model.

BoDsearch for term

BRIDG Board of Directors.

BR&Rsearch for term

Biomedical Research and Regulation – A new HL7 work group formed by the merger of the HL7 BRIDG an RCRIM work groups.

BRIDGsearch for term

Biomedical Research Integrated Domain Group.

C3PRsearch for term

caBIG Central Clinical Participant Registry - An open source NCI Application for registering participants on a clinical trial.

caAERSsearch for term

caBIG Adverse Event Reporting System - An NCI open source application solution for reporting adverse events. Learn more.

caBIGsearch for term

cancer Biomedical Informatics Grid - A National Cancer Institute (NCI) initiative to create a virtual network of interconnected data, individuals, and organizations that work together to redefine how cancer research is conducted.  Learn more about caBIG.

caXchangesearch for term

cancer Exchange - A caBIG® Integration Hub (formerly called caXchange) provides integration among caBIG® Clinical Trials Suite applications that need to exchange information, messages and invoke remote services. Learn more about the Integration Hub.

CDASHsearch for term

Clinical Data Acquisition Standards Harmonization - A CDISC standard that describes the basic recommended (minimal) data collection fields for 18 domains, including common header fields, and demographic, adverse events, and other safety domains that are common to all therapeutic areas and phases of clinical research. Learn more about CDASH.

CDISCsearch for term

Clinical Data Interchange Standards Consortium - CDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. Learn more about the CDISC organization.

CMETsearch for term

Common Model Element Type -  A  CMET can be envisioned as a HL7 message type fragment that is reusable by other message types in HL7.  CMETs are typically developed for concepts that are common across many domains of healthcare, for example, use of person in a role of patient.

Complex Data Typessearch for term

A datatype specification that contains component parts, see Abstract datatypes, ISO 21090 and HL7 Datatypes R2.

CSIsearch for term

Computable Semantic Interoperability - The ability of computer systems to communicate information and have that information properly interpreted by the receiving system in the same sense as intended by the transmitting system.

CTODSsearch for term

Clinical Trials Object Data System - CTODS has been developed within the cancer Biomedical Informatics Grid (caBIG®) program to enable the exchange of de-identified clinical trials data across multiple systems while supporting syntactic and semantic interoperability.

CTOMsearch for term

Clinical Trials Object Model. (The new name for this is CTODS.)

CTR&Rsearch for term

Clinical Trials Registration and Results - A HL7 project that is focused on the development and maintenance of an HL7 V3 message in support of the global data exchange requirements brought about by the increasing number of national, regional, global and organizational clinical trial registries and trial results databases.

DAMsearch for term

Domain Analysis Model - A DAM is an abstract representation of a subject area of interest, complete enough to allow instantiation of all necessary concrete classes needed to develop child design artifacts.

DICOMsearch for term

Digital Imaging and Communications in Medicine – Digital Imaging and Communications in Medicine (DICOM) is a standard for handling, storing, printing, and transmitting information in medical imaging.

DMIMsearch for term

Domain Message Information Model - An HL7 term, DMIMs are Domain models representing a committee's (or group of committee's) understanding of the "data" and relationships that are relevant within the area of clinical or administrative knowledge represented by that domain expressed in HL7 modeling terms.

Dynamic Semanticssearch for term

Dynamic Semantics - The various processes, activity flows and interactions of a domain analysis model. Dynamic components include storyboards, activity diagrams, state diagrams, and sequence diagrams.

EAsearch for term

Enterprise Architect - A UML modeling tool from Sparx Systems.  The BRIDG Project uses the Enterprise Architect tool to develop and maintain the BRIDG model.

FDAsearch for term

Food and Drug Administration - A United States federal agency under the Department of Health and Human Services (HHS).  FDA is also one of the four stakeholders of the BRIDG project.

FHIMSsearch for term

Federal Health Information Model and Standards - The FHIMS program is intended to coordinate the efforts of the partner agencies with the development of Electronic Medical Records, information and terminology standards, including the coordination of agency efforts at relevant Standards Development Organizations (SDOs). 

Harmonizationsearch for term

Bringing semantics from project models into BRIDG.

HL7search for term

Health Level 7 - A not-for-profit, ANSI-accredited standards developing organization dedicated to providing a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information that supports clinical practice and the management, delivery and evaluation of health services.

ISOsearch for term

International Standards Organization (ISO).

ISO 21090search for term

International Standards Organization (ISO) 21090 - An ISO standard for data types.  Provides a set of datatype definitions for representing and exchanging basic concepts that are commonly encountered in healthcare.

Lab Viewersearch for term

Lab Viewer is a web-based application that allows users to view laboratory data stored in the Lab-based database. Lab Viewer is one of the core applications of the NCI caBIG® Clinical Trials Suite. Lab Viewer can send and receive clinical data (via the caBIG® Integration Hub) from existing laboratory information management systems (LIMS), patient registries, adverse event systems, electronic patient calendars, electronic case report forms, and other clinical data collection systems.

LOINCsearch for term

Logical Observation Identifiers Names and Codes - A universal code system for identifying laboratory and clinical observations.

Mapping Spreadsheetsearch for term

A BRIDG project artifact. An Excel spreadsheet that documents how items (classes and attributes) from a project model map to classes and attributes in the BRIDG model. This spreadsheet is part of the BRIDG Harmonization package.

MedDRAsearch for term

Medical Dictionary for Regulatory Activities - A medical terminology used to classify adverse event information associated with the use of biopharmaceuticals and other medical products (e.g., medical devices and vaccines).

MIFsearch for term

Model Interchange Format -  A set of XML formats used to support the storage and exchange of HL7 version 3 artifacts as part of the HL7 Development Framework

NBIAsearch for term

National Biomedical Imaging Archive - A searchable, national repository integrating in vivo cancer images with clinical and genomic data. NBIA provides the cancer research community, industry, and academia with public access to DICOM images, image markup, annotations, and rich meta data.

NCIsearch for term

National Cancer Institute - NCI is part of the United States National Institutes of Health (NIH), which is one of 11 agencies that compose the Department of Health and Human Services (HHS). NCI is also one of the four stakeholders of the BRIDG model.

OWLsearch for term

Web Ontology Language - OWL is a language for processing web information.

POCsearch for term

Point of Contact -  In BRIDG project, when a team brings their project for harmonization, the BRIDG Semantic Coordination Committe (SCC) assigns a person from the SCC as a POC for the project team to help the team get started on building the harmonization mapping sheets.

PSCsearch for term

Patient Study Calendar - The Patient Study Calendar (PSC) is an open source, standards-compliant software application intended for use by organizations that manage patients on clinical trials. PSC is a web-based application providing the ability to create and edit study calendar templates, generate and view prospective calendars of patient activities, track activities as they occur, and manage patient calendars as they change during a study. 

RCRIMsearch for term

Regulated Clinical Research Information Management - A HL7 technical committee that supports the HL7 mission to create and promote HL7 standards by developing standards to improve or enhance information management during preclinical research, clinical research and regulatory evaluation of the safety, efficacy and quality of therapeutic products and procedures worldwide.

RIMsearch for term

Reference Information Model - The Reference Information Model (RIM) is the cornerstone of the HL7 Version 3 development process. An object model created as part of the Version 3 methodology, the RIM is a large, pictorial representation of the HL7 clinical data (domains) and identifies the life cycle that a message or groups of related messages will carry. It is a shared model between all domains and, as such, is the model from which all domains create their messages. The RIM is an ANSI approved standard

RIM-based Modelsearch for term

A representation of the BRIDG model based on the HL7 RIM.

RMIMsearch for term

Refined Message Information Model - An information structure that represents the requirements for a set of messages. A   constrained subset of the Reference Information Model (RIM) which MAY contain additional classes that are cloned from RIM classes. 

RPSsearch for term

Regulated Product Submission - An HL7 message that supports the submission of all regulated products to the US Food and Drug Administration (FDA).

SCCsearch for term

Semantic Coordination Committee - A BRIDG project team that is responsible for modeling and maintaining the BRIDG model.

SDTMsearch for term

Study Data Tabulation Model - A CDISC standard that defines a standard structure for human clinical trial (study) data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Adminsitration (FDA). 

SEERsearch for term

Surveillance, Epidemiology, and End Results – The SEER Program of the National Cancer Institute (NCI) is an authoritative source of information on cancer incidence and survival in the United States.  To learn more about SEER program, visit https://seer.cancer.gov/

SHAREsearch for term

Shared Health And Clinical Research Electronic Library - CDISC SHARE is a global, accessible, electronic library, which through advanced technology, enables precise and standardized data element definitions that can be used within applications and across studies to improve biomedical research and its link with healthcare.

SMEsearch for term

Subject matter expert.

SNOMED - CTsearch for term

Systematic Nomenclature of Medicine - Clinical Terms - is a comprehensive clinical terminology, originally created by the College of American Pathologists (CAP) and, as of April 2007, owned, maintained, and distributed by the International Health Terminology Standards Development Organisation (IHTSDO), a not-for-profit association in Denmark. The CAP continues to support SNOMED CT operations under contract to the IHTSDO and provides SNOMED-related products and services as a licensee of the terminology.

TDMsearch for term

Trial Design Model - A CDISC standard that allows organizations to provide rigorous, machine-readable, interchangeable descriptions of the designs of their clinical studies.  Also referred to as Study Trial Design.

UCUMsearch for term

Unified Code for Units of Measure - A code system intended to include all units of measures being contemporarily used in international science, engineering, and business. The purpose is to facilitate unambiguous electronic communication of quantities together with their units.

UMLsearch for term

Unified Modeling Language - UML® helps you specify, visualize, and document models of software systems, including their structure and design, in a way that meets all of these requirements. UML can also be used for business modeling and modeling of other non-software systems too. 

XMIsearch for term

XML Metadata Interchange - It is an Object Management Group (OMG) standard for exchanging metadata information via Extensible Markup Language (XML).  It can be used for any metadata whose metamodel can be expressed in Meta-Object Facility (MOF).  The most common use of XMI is as an interchange format for UML models, although it can also be used for serialization of models of other languages (metamodels).

XMLsearch for term

Extensible Markup Language -  It is a simple, very flexible text format derived from SGML (ISO 8879). Originally designed to meet the challenges of large-scale electronic publishing, XML is also playing an increasingly important role in the exchange of a wide variety of data on the Web and elsewhere.