Steve Canham1, Christian Ohmann2. 1. European Clinical Research Infrastructure Network (ECRIN), Kings Avenue, Redhill, RH16QH, UK. 2. European Clinical Research Infrastructure Network (ECRIN), Kaiserswerther Strasse 70, 40477, Düsseldorf, Germany. christian.ohmann@med.uni-duesseldorf.de.
Abstract
BACKGROUND: A large number of stakeholders have accepted the need for greater transparency in clinical research and, in the context of various initiatives and systems, have developed a diverse and expanding number of repositories for storing the data and documents created by clinical studies (collectively known as data objects). To make the best use of such resources, we assert that it is also necessary for stakeholders to agree and deploy a simple, consistent metadata scheme. METHODS: The relevant data objects and their likely storage are described, and the requirements for metadata to support data sharing in clinical research are identified. Issues concerning persistent identifiers, for both studies and data objects, are explored. RESULTS: A scheme is proposed that is based on the DataCite standard, with extensions to cover the needs of clinical researchers, specifically to provide (a) study identification data, including links to clinical trial registries; (b) data object characteristics and identifiers; and (c) data covering location, ownership and access to the data object. The components of the metadata scheme are described. CONCLUSIONS: The metadata schema is proposed as a natural extension of a widely agreed standard to fill a gap not tackled by other standards related to clinical research (e.g., Clinical Data Interchange Standards Consortium, Biomedical Research Integrated Domain Group). The proposal could be integrated with, but is not dependent on, other moves to better structure data in clinical research.
BACKGROUND: A large number of stakeholders have accepted the need for greater transparency in clinical research and, in the context of various initiatives and systems, have developed a diverse and expanding number of repositories for storing the data and documents created by clinical studies (collectively known as data objects). To make the best use of such resources, we assert that it is also necessary for stakeholders to agree and deploy a simple, consistent metadata scheme. METHODS: The relevant data objects and their likely storage are described, and the requirements for metadata to support data sharing in clinical research are identified. Issues concerning persistent identifiers, for both studies and data objects, are explored. RESULTS: A scheme is proposed that is based on the DataCite standard, with extensions to cover the needs of clinical researchers, specifically to provide (a) study identification data, including links to clinical trial registries; (b) data object characteristics and identifiers; and (c) data covering location, ownership and access to the data object. The components of the metadata scheme are described. CONCLUSIONS: The metadata schema is proposed as a natural extension of a widely agreed standard to fill a gap not tackled by other standards related to clinical research (e.g., Clinical Data Interchange Standards Consortium, Biomedical Research Integrated Domain Group). The proposal could be integrated with, but is not dependent on, other moves to better structure data in clinical research.
Entities:
Keywords:
Data repositories; Data sharing; ECRIN; European Clinical Research Infrastructure Network; Identifiers; Metadata; Standards; Transparency
Authors: Stefania Boccia; Kenneth J Rothman; Nikola Panic; Maria Elena Flacco; Annalisa Rosso; Roberta Pastorino; Lamberto Manzoli; Carlo La Vecchia; Paolo Villari; Paolo Boffetta; Walter Ricciardi; John P A Ioannidis Journal: J Clin Epidemiol Date: 2015-09-18 Impact factor: 6.437
Authors: Darren B Taichman; Joyce Backus; Christopher Baethge; Howard Bauchner; Peter W de Leeuw; Jeffrey M Drazen; John Fletcher; Frank A Frizelle; Trish Groves; Abraham Haileamlak; Astrid James; Christine Laine; Larry Peiperl; Anja Pinborg; Peush Sahni; Sinan Wu Journal: JAMA Date: 2016-02-02 Impact factor: 56.272
Authors: Paul Glasziou; Douglas G Altman; Patrick Bossuyt; Isabelle Boutron; Mike Clarke; Steven Julious; Susan Michie; David Moher; Elizabeth Wager Journal: Lancet Date: 2014-01-08 Impact factor: 79.321
Authors: Christian Ohmann; Rita Banzi; Steve Canham; Serena Battaglia; Mihaela Matei; Christopher Ariyo; Lauren Becnel; Barbara Bierer; Sarion Bowers; Luca Clivio; Monica Dias; Christiane Druml; Hélène Faure; Martin Fenner; Jose Galvez; Davina Ghersi; Christian Gluud; Trish Groves; Paul Houston; Ghassan Karam; Dipak Kalra; Rachel L Knowles; Karmela Krleža-Jerić; Christine Kubiak; Wolfgang Kuchinke; Rebecca Kush; Ari Lukkarinen; Pedro Silverio Marques; Andrew Newbigging; Jennifer O'Callaghan; Philippe Ravaud; Irene Schlünder; Daniel Shanahan; Helmut Sitter; Dylan Spalding; Catrin Tudur-Smith; Peter van Reusel; Evert-Ben van Veen; Gerben Rienk Visser; Julia Wilson; Jacques Demotes-Mainard Journal: BMJ Open Date: 2017-12-14 Impact factor: 2.692