Foundations of a metadata repository for databases of registers and trials.
Identifieur interne : 000646 ( Ncbi/Checkpoint ); précédent : 000645; suivant : 000647Foundations of a metadata repository for databases of registers and trials.
Auteurs : Jürgen Stausberg [Allemagne] ; Matthias Löbe ; Philippe Verplancke ; Johannes Drepper ; Heinrich Herre ; Markus LöfflerSource :
- Studies in health technology and informatics [ 0926-9630 ] ; 2009.
Descripteurs français
- KwdFr :
- MESH :
- organisation et administration : Bases de données comme sujet.
- Enregistrements, Essais cliniques comme sujet.
English descriptors
- KwdEn :
- MESH :
- organization & administration : Databases as Topic.
- Clinical Trials as Topic, Registries.
Abstract
The planning of case report forms (CRFs) in clinical trials or databases in registers is mostly an informal process starting from scratch involving domain experts, biometricians, and documentation specialists. The Telematikplattform für Medizinische Forschungsnetze, an umbrella organization for medical research in Germany, aims at supporting and improving this process with a metadata repository, covering the variables and value lists used in databases of registers and trials. The use cases for the metadata repository range from a specification of case report forms to the harmonization of variable collections, variables, and value lists through a formal review. The warehouse used for the storage of the metadata should at least fulfill the definition of part 3 "Registry metamodel and basic attributes" of ISO/IEC 11179 Information technology - Metadata registries. An implementation of the metadata repository should offer an import and export of metadata in the Operational Data Model standard of the Clinical Data Interchange Standards Consortium. It will facilitate the creation of CRFs and data models, improve the quality of CRFs and data models, support the harmonization of variables and value lists, and support the mapping of metadata and data.
PubMed: 19745342
Affiliations:
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pubmed:19745342Le document en format XML
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first="Matthias" last="Löbe">Matthias Löbe</name></author><author><name sortKey="Verplancke, Philippe" sort="Verplancke, Philippe" uniqKey="Verplancke P" first="Philippe" last="Verplancke">Philippe Verplancke</name></author><author><name sortKey="Drepper, Johannes" sort="Drepper, Johannes" uniqKey="Drepper J" first="Johannes" last="Drepper">Johannes Drepper</name></author><author><name sortKey="Herre, Heinrich" sort="Herre, Heinrich" uniqKey="Herre H" first="Heinrich" last="Herre">Heinrich Herre</name></author><author><name sortKey="Loffler, Markus" sort="Loffler, Markus" uniqKey="Loffler M" first="Markus" last="Löffler">Markus Löffler</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2009">2009</date><idno type="RBID">pubmed:19745342</idno><idno type="pmid">19745342</idno><idno type="wicri:Area/PubMed/Corpus">000359</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000359</idno><idno 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Faculty, Ludwig-Maximilians-Universität München, D-81377 München</wicri:regionArea><placeName><region type="land" nuts="1">Bavière</region><region type="district" nuts="2">District de Haute-Bavière</region><settlement type="city">Munich</settlement></placeName><orgName type="university">Université Louis-et-Maximilien de Munich</orgName></affiliation></author><author><name sortKey="Lobe, Matthias" sort="Lobe, Matthias" uniqKey="Lobe M" first="Matthias" last="Löbe">Matthias Löbe</name></author><author><name sortKey="Verplancke, Philippe" sort="Verplancke, Philippe" uniqKey="Verplancke P" first="Philippe" last="Verplancke">Philippe Verplancke</name></author><author><name sortKey="Drepper, Johannes" sort="Drepper, Johannes" uniqKey="Drepper J" first="Johannes" last="Drepper">Johannes Drepper</name></author><author><name sortKey="Herre, Heinrich" sort="Herre, Heinrich" uniqKey="Herre H" first="Heinrich" last="Herre">Heinrich Herre</name></author><author><name sortKey="Loffler, Markus" sort="Loffler, Markus" uniqKey="Loffler M" first="Markus" last="Löffler">Markus Löffler</name></author></analytic><series><title level="j">Studies in health technology and informatics</title><idno type="ISSN">0926-9630</idno><imprint><date when="2009" type="published">2009</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Clinical Trials as Topic</term><term>Databases as Topic (organization & administration)</term><term>Registries</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Bases de données comme sujet (organisation et administration)</term><term>Enregistrements</term><term>Essais cliniques comme sujet</term></keywords><keywords scheme="MESH" qualifier="organisation et administration" xml:lang="fr"><term>Bases de données comme sujet</term></keywords><keywords scheme="MESH" qualifier="organization & administration" xml:lang="en"><term>Databases as Topic</term></keywords><keywords 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The Telematikplattform für Medizinische Forschungsnetze, an umbrella organization for medical research in Germany, aims at supporting and improving this process with a metadata repository, covering the variables and value lists used in databases of registers and trials. The use cases for the metadata repository range from a specification of case report forms to the harmonization of variable collections, variables, and value lists through a formal review. The warehouse used for the storage of the metadata should at least fulfill the definition of part 3 "Registry metamodel and basic attributes" of ISO/IEC 11179 Information technology - Metadata registries. An implementation of the metadata repository should offer an import and export of metadata in the Operational Data Model standard of the Clinical Data Interchange Standards Consortium. It will facilitate the creation of CRFs and data models, improve the quality of CRFs and data models, support the harmonization of variables and value lists, and support the mapping of metadata and data.</div></front></TEI><affiliations><list><country><li>Allemagne</li></country><region><li>Bavière</li><li>District de Haute-Bavière</li></region><settlement><li>Munich</li></settlement><orgName><li>Université Louis-et-Maximilien de Munich</li></orgName></list><tree><noCountry><name sortKey="Drepper, Johannes" sort="Drepper, Johannes" uniqKey="Drepper J" first="Johannes" last="Drepper">Johannes Drepper</name><name sortKey="Herre, Heinrich" sort="Herre, Heinrich" uniqKey="Herre H" first="Heinrich" last="Herre">Heinrich Herre</name><name sortKey="Lobe, Matthias" sort="Lobe, Matthias" uniqKey="Lobe M" first="Matthias" last="Löbe">Matthias Löbe</name><name sortKey="Loffler, Markus" sort="Loffler, Markus" uniqKey="Loffler M" first="Markus" last="Löffler">Markus Löffler</name><name sortKey="Verplancke, Philippe" sort="Verplancke, Philippe" uniqKey="Verplancke P" first="Philippe" last="Verplancke">Philippe Verplancke</name></noCountry><country name="Allemagne"><region name="Bavière"><name sortKey="Stausberg, Jurgen" sort="Stausberg, Jurgen" uniqKey="Stausberg J" first="Jürgen" last="Stausberg">Jürgen Stausberg</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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