Integrated Data Management for Clinical Studies: Automatic Transformation of Data Models with Semantic Annotations for Principal Investigators, Data Managers and Statisticians
Design, execution and analysis of clinical studies involves several stakeholders with different professional backgrounds. Typically, principle investigators are familiar with standard office tools, data managers apply electronic data capture (EDC) systems and statisticians work with statistics softw...
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| Published in | PloS one Vol. 9; no. 2; p. e90492 |
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| Main Authors | , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Public Library of Science
28.02.2014
Public Library of Science (PLoS) |
| Subjects | |
| Online Access | Get full text |
| ISSN | 1932-6203 1932-6203 |
| DOI | 10.1371/journal.pone.0090492 |
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| Abstract | Design, execution and analysis of clinical studies involves several stakeholders with different professional backgrounds. Typically, principle investigators are familiar with standard office tools, data managers apply electronic data capture (EDC) systems and statisticians work with statistics software. Case report forms (CRFs) specify the data model of study subjects, evolve over time and consist of hundreds to thousands of data items per study. To avoid erroneous manual transformation work, a converting tool for different representations of study data models was designed. It can convert between office format, EDC and statistics format. In addition, it supports semantic annotations, which enable precise definitions for data items. A reference implementation is available as open source package ODMconverter at http://cran.r-project.org. |
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| AbstractList | Design, execution and analysis of clinical studies involves several stakeholders with different professional backgrounds. Typically, principle investigators are familiar with standard office tools, data managers apply electronic data capture (EDC) systems and statisticians work with statistics software. Case report forms (CRFs) specify the data model of study subjects, evolve over time and consist of hundreds to thousands of data items per study. To avoid erroneous manual transformation work, a converting tool for different representations of study data models was designed. It can convert between office format, EDC and statistics format. In addition, it supports semantic annotations, which enable precise definitions for data items. A reference implementation is available as open source package ODMconverter at http://cran.r-project.org. Design, execution and analysis of clinical studies involves several stakeholders with different professional backgrounds. Typically, principle investigators are familiar with standard office tools, data managers apply electronic data capture (EDC) systems and statisticians work with statistics software. Case report forms (CRFs) specify the data model of study subjects, evolve over time and consist of hundreds to thousands of data items per study. To avoid erroneous manual transformation work, a converting tool for different representations of study data models was designed. It can convert between office format, EDC and statistics format. In addition, it supports semantic annotations, which enable precise definitions for data items. A reference implementation is available as open source package ODMconverter at Design, execution and analysis of clinical studies involves several stakeholders with different professional backgrounds. Typically, principle investigators are familiar with standard office tools, data managers apply electronic data capture (EDC) systems and statisticians work with statistics software. Case report forms (CRFs) specify the data model of study subjects, evolve over time and consist of hundreds to thousands of data items per study. To avoid erroneous manual transformation work, a converting tool for different representations of study data models was designed. It can convert between office format, EDC and statistics format. In addition, it supports semantic annotations, which enable precise definitions for data items. A reference implementation is available as open source package ODMconverter at http://cran.r-project.org.Design, execution and analysis of clinical studies involves several stakeholders with different professional backgrounds. Typically, principle investigators are familiar with standard office tools, data managers apply electronic data capture (EDC) systems and statisticians work with statistics software. Case report forms (CRFs) specify the data model of study subjects, evolve over time and consist of hundreds to thousands of data items per study. To avoid erroneous manual transformation work, a converting tool for different representations of study data models was designed. It can convert between office format, EDC and statistics format. In addition, it supports semantic annotations, which enable precise definitions for data items. A reference implementation is available as open source package ODMconverter at http://cran.r-project.org. |
| Audience | Academic |
| Author | Dugas-Breit, Susanne Dugas, Martin |
| AuthorAffiliation | 2 Klinik und Poliklinik für Dermatologie und Allergologie, Ludwig-Maximilians-Universitaet, Munich, Germany The Cochrane Collaboration, Germany 1 Institute of Medical Informatics, University of Münster, Münster, Germany |
| AuthorAffiliation_xml | – name: 1 Institute of Medical Informatics, University of Münster, Münster, Germany – name: 2 Klinik und Poliklinik für Dermatologie und Allergologie, Ludwig-Maximilians-Universitaet, Munich, Germany – name: The Cochrane Collaboration, Germany |
| Author_xml | – sequence: 1 givenname: Martin surname: Dugas fullname: Dugas, Martin – sequence: 2 givenname: Susanne surname: Dugas-Breit fullname: Dugas-Breit, Susanne |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/24587378$$D View this record in MEDLINE/PubMed |
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| CitedBy_id | crossref_primary_10_1016_j_jbi_2015_06_023 crossref_primary_10_1093_database_bav121 crossref_primary_10_1186_s12874_016_0164_9 crossref_primary_10_1016_j_jbi_2016_02_016 crossref_primary_10_1016_j_jbi_2016_10_010 crossref_primary_10_1016_j_jbi_2017_05_003 |
| Cites_doi | 10.1371/journal.pone.0067883 10.4338/ACI-2012-03-RA-0011 10.1016/j.ejca.2006.09.016 |
| ContentType | Journal Article |
| Copyright | COPYRIGHT 2014 Public Library of Science 2014 Dugas, Dugas-Breit. This is an open-access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. 2014 Dugas, Dugas-Breit 2014 Dugas, Dugas-Breit |
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| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 Competing Interests: The authors have declared that no competing interests exist. Conceived and designed the experiments: MD SD. Performed the experiments: MD. Analyzed the data: MD. Contributed reagents/materials/analysis tools: MD. Wrote the paper: MD SD. |
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| SubjectTerms | Annotations Automation Biology Biomedical Research - methods Biomedical Research - statistics & numerical data Cancer Clinical trials Codes Computer Science Data analysis Data capture Data management Data models Design Format Freeware Humans Informatics Information Storage and Retrieval - methods Internet Interoperability Jargon Medical Informatics Computing - statistics & numerical data Medical Records Systems, Computerized - statistics & numerical data Medical research Medicine Metadata Methods Reproducibility of Results Research Personnel Semantics Software Statistical analysis Studies Terminology Transformation Values |
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| Title | Integrated Data Management for Clinical Studies: Automatic Transformation of Data Models with Semantic Annotations for Principal Investigators, Data Managers and Statisticians |
| URI | https://www.ncbi.nlm.nih.gov/pubmed/24587378 https://www.proquest.com/docview/1503272435 https://www.proquest.com/docview/1504162582 https://pubmed.ncbi.nlm.nih.gov/PMC3938746 https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0090492&type=printable https://doaj.org/article/276f5cee11c54403b559b7895f95a552 http://dx.doi.org/10.1371/journal.pone.0090492 |
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