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Metadata-driven software for clinical trials

Charles Crichton, Jim Davies, Jeremy Gibbons, Steve Harris, Andrew Tsui, James Brenton
2009 2009 ICSE Workshop on Software Engineering in Health Care  
The metamodel is instantiated with metadata elements drawn from a repository, to create a model of a particular clinical trial.  ...  The CancerGrid approach to clinical trials information systems is based on a metamodel developed from the CON-SORT statement of best practice in reporting randomised controlled trials.  ...  quent reuse and integration; this metadata is preserved and propagated throughout the life of the data it describes.  ... 
doi:10.1109/sehc.2009.5069600 dblp:conf/icse/CrichtonDGHTB09 fatcat:eherdolvsjf5dcifequwicpj4m

The CancerGrid experience: Metadata-based model-driven engineering for clinical trials

Jim Davies, Jeremy Gibbons, Steve Harris, Charles Crichton
2014 Science of Computer Programming  
. • Software support for cancer clinical trials, and similar data collection exercises. • Metadata support, to enable subsequent meta-analysis. • Model-driven generation of software artefacts to run trial  ...  In other words, clinical trials management is crying out for a model-driven approach.  ...  The CONSORT trials metamodel and the forms-based approach to model-driven engineering are described in a couple of conference papers [24, 18] .  ... 
doi:10.1016/j.scico.2013.02.010 fatcat:xkbamlmonffspc5wxgf7zbg6vi

Form Follows Function: Model-Driven Engineering for Clinical Trials

Jeremy Gibbons
2011 Electronic Proceedings in Theoretical Computer Science  
In particular, in the CancerGrid project, we have been developing model-driven techniques for the generation of software tools to support clinical trials.  ...  We argue that, for certain constrained domains, elaborate model transformation technologies-implemented from scratch in generalpurpose programming languages-are unnecessary for model-driven engineering  ...  In other words, clinical trials management is crying out for a model-driven engineering (MDE) approach.  ... 
doi:10.4204/eptcs.66.0.1 fatcat:26sr2qkqnzgmbjwaamtg5la4mq

Design and multicentric Implementation of a generic Software Architecture for Patient Recruitment Systems re-using existing HIS tools and Routine Patient Data

B. Trinczek, F. Köpcke, T. Leusch, R. W. Majeed, B. Schreiweis, J. Wenk, B. Bergh, C. Ohmann, R. Röhrig, H. U. Prokosch, M. Dugas
2014 Applied Clinical Informatics  
Clinical Relevance Statement With an increasing number of clinical trials conducted at hospitals and higher workload for clinical staff, there is a demand for software-based Patient Recruitment Systems  ...  In its most simple implementation option, the Trial Administration Module might be implemented by using a paper-or form-driven documentation and inserting necessary trial metadata into the other modules  ...  Appendix 1 List of questions used for site analysis • Does the site have a software to administrate trials? • For each implementation options: -Is it possible to add, update and delete trials?  ... 
doi:10.4338/aci-2013-07-ra-0047 pmid:24734138 pmcid:PMC3974260 fatcat:y6kdbijflndq5nzi6cnpue5i2q

Model-driven architecture for cancer research

Radu Calinescu, Steve Harris, Jeremy Gibbons, Jim Davies, Igor Toujilov, Sylvia B. Nagl
2007 Fifth IEEE International Conference on Software Engineering and Formal Methods (SEFM 2007)  
across clinical trial boundaries.  ...  cancer clinical trial research, an area particularly affected by these problems.  ...  The authors are grateful to Charlie Crichton, Peter Maccallum, Andrew Tsui and the other members of the CancerGrid team for many insightful discussions during the work on the model-driven development framework  ... 
doi:10.1109/sefm.2007.26 dblp:conf/sefm/CalinescuHGDTN07 fatcat:dut4a5z6wfcbtiqd6os27ecfv4

Research electronic data capture (REDCap)—A metadata-driven methodology and workflow process for providing translational research informatics support

Paul A. Harris, Robert Taylor, Robert Thielke, Jonathon Payne, Nathaniel Gonzalez, Jose G. Conde
2009 Journal of Biomedical Informatics  
We present: (1) a brief description of the REDCap metadata-driven software toolset; (2) detail concerning the capture and use of study-related metadata from scientific research teams; (3) measures of impact  ...  Research electronic data capture (REDCap) is a novel workflow methodology and software solution designed for rapid development and deployment of electronic data capture tools to support clinical and translational  ...  Acknowledgments We gratefully acknowledge: Jerry Zhao (Vanderbilt University) for assistance with Vanderbilt computing resources; Maricruz Silva-Ramos (University of Miami) for assistance with data export  ... 
doi:10.1016/j.jbi.2008.08.010 pmid:18929686 pmcid:PMC2700030 fatcat:udvvrkik2jcvlmvd2b4wu2r2ya

BRIDG-based Trial Metadata Repository - Need for Standardized Machine Interpretable Trial Descriptions
english

Jasper van Leeuwen, Anca I. D. Bucur, Brecht Claerhout, Kristof de Schepper, David Pérez-Rey, Raúl Alonso-Calvo
2014 Proceedings of the International Conference on Health Informatics  
Repository for a patient screening application for clinical trials.  ...  with a focus on interoperability and machine interpretability to enable more efficient support for clinical research and faster knowledge transfer into care, We further exemplify the use of the Trial Metadata  ...  The development of the trial metadata repository is based on a model driven approach.  ... 
doi:10.5220/0004910304530458 dblp:conf/biostec/LeeuwenBCSPA14 fatcat:pgqzgcrvszbijhoctfbor2siai

ODM Clinical Data Generator: Syntactically Correct Clinical Data Based on Metadata Definition [chapter]

Tobias J. Brix, Ludger Becker, Timm Harbich, Johannes Oehm, Maximilian Fechner, Martin Dugas, Michael Storck
2021 Studies in Health Technology and Informatics  
The Operational Data Model (ODM) is a data standard for interchanging clinical trial data.  ...  Thus, in combination with the portal of medical data models, a large number of ODM files including metadata definition and clinical data can be provided for testing of any ODM supporting system.  ...  The software was able to generate clinical data for the ODM metadata files with different numbers of items and subject counts. All files are available from MDM Portal.  ... 
doi:10.3233/shti210048 pmid:34042873 fatcat:c7xhsxbxxbentpjvicz27d52h4

S2O – A software tool for integrating research data from general purpose statistic software into electronic data capture systems

Philipp Bruland, Martin Dugas
2017 BMC Medical Informatics and Decision Making  
Advantages of EDC systems are support for multi-user and multicenter clinical trials as well as auditable data.  ...  Therefore, such systems are not able to comply with regulatory requirements for electronic data capture in clinical trials.  ...  for the conduct of clinical trials.  ... 
doi:10.1186/s12911-016-0402-4 pmid:28061771 pmcid:PMC5219713 fatcat:osxjxta65neaxpsb7n6pugshnm

Comparison and transformation between CDISC ODM and EN13606 EHR standards in connecting EHR data with clinical trial research data

Archana Tapuria, Philipp Bruland, Brendan Delaney, Dipak Kalra, Vasa Curcin
2018 Digital Health  
EN13606 can accommodate clinical information in a more structured manner with more constraints, whereas CDISC ODM is more suitable and specific for clinical trials and studies.  ...  Data Model (CDISC ODM) used for clinical research.  ...  Acknowledgements: We thanks the Institute of Medical Informatics, University of Mu¨nster, Germany, for allowing us to use the Medical Data Models portal.  ... 
doi:10.1177/2055207618777676 pmid:29942639 pmcid:PMC6016569 fatcat:2w4uha3lwnhv3fbm52r4tknfyq

Domain specific modelling for clinical research

Jim Davies, Jeremy Gibbons, Adam Milward, David Milward, Seyyed Shah, Monika Solanki, James Welch
2015 Proceedings of the Workshop on Domain-Specific Modeling - DSM 2015  
This paper explains how a model-driven approach to software engineering and data management, in which software artefacts are generated automatically from data models, and models are used as metadata, can  ...  It reports upon the application of this approach in the provision of informatics support for two large-scale clinical research initiatives.  ...  We are very grateful for the contributions made by colleagues at the University of Oxford: in particular, Steve Harris and Charles Crichton.  ... 
doi:10.1145/2846696.2846701 dblp:conf/oopsla/DaviesGMMSSW15 fatcat:uudnbpirwnemxncmpxgenm42ty

Metadata-driven creation of data marts from an EAV-modeled clinical research database

Cynthia A Brandt, Richard Morse, Keri Matthews, Kexin Sun, Aniruddha M Deshpande, Rohit Gadagkar, Dorothy B Cohen, Perry L Miller, Prakash M Nadkarni
2002 International Journal of Medical Informatics  
They achieve this by using an Entity-Attribute-Value (EAV) model for clinical data.  ...  Generic clinical study data management systems can record data on an arbitrary number of parameters in an arbitrary number of clinical studies without requiring modification of the database schema.  ...  Timothy Rebbeck of the University of Pennsylvania provided valuable feedback that led to improvement of the software.  ... 
doi:10.1016/s1386-5056(02)00047-3 pmid:12414020 fatcat:ywqgi2pabbezhmjdjykaekcpeu

OnWARD: Ontology-driven web-based framework for multi-center clinical studies

Van-Anh Tran, Nathan Johnson, Susan Redline, Guo-Qiang Zhang
2011 Journal of Biomedical Informatics  
for large-scale multi-center trials.  ...  This paper presents OnWARD, an ontology-driven, secure, rapidlydeployed, web-based framework supporting data capture for large-scale multi-center clinical research.  ...  Acknowledgments This publication was made possible by the Case Western Reserve University/Cleveland Clinic CTSA (UL1 RR024989) from the National Center for Research Resources (NCRR), by the Physio-MIMI  ... 
doi:10.1016/j.jbi.2011.08.019 pmid:21924379 pmcid:PMC3251701 fatcat:zug5vnxsozf5xn25tiqhrgyvry

ProvCaRe Semantic Provenance Knowledgebase: Evaluating Scientific Reproducibility of Research Studies

Joshua Valdez, Matthew Kim, Michael Rueschman, Vimig Socrates, Susan Redline, Satya S Sahoo
2018 AMIA Annual Symposium Proceedings  
Scientific reproducibility is critical for biomedical research as it enables us to advance science by building on previous results, helps ensure the success of increasingly expensive drug trials, and allows  ...  As part of the NIH Big Data to Knowledge (BD2K)-funded data provenance project, we have developed a new informatics framework called Provenance for Clinical and Healthcare Research (ProvCaRe) to extract  ...  and clinical trials (14) .  ... 
pmid:29854241 pmcid:PMC5977728 fatcat:qsxwi5zjrfashfzdk3ovpvnhtm

Development of the Lymphoma Enterprise Architecture Database: a caBIG Silver level compliant system

Taoying Huang, Pareen J Shenoy, Rajni Sinha, Michael Graiser, Kevin W Bumpers, Christopher R Flowers
2009 Cancer Informatics  
trials, and clinical data from institutional databases.  ...  We utilized the Cancer Common Ontological Representation Environment Software Development Kit (caCORE SDK) provided by National Cancer Institute's Center for Bioinformatics to establish the LEAD platform  ...  A model driven information system using the cancer Common Ontological Representation Environment; a synthesis of software, vocabulary, and metadata models for cancer research.  ... 
pmid:19492074 pmcid:PMC2675136 fatcat:dy2th4h32nbexcp7j7m34xvcuy
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