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  1. Article ; Online: ECRIN – CESSDA strategies for cross metadata mappings in selected areas between life sciences and social sciences and humanities [version 1; peer review

    Christian Ohmann / Steve Canham / Katja Moilanen / Mari Kleemola / Maria Panagiotopoulou

    Open Research Europe, Vol

    1 approved, 2 approved with reservations]

    2023  Volume 3

    Abstract: Background: The recent COVID-19 pandemic dramatically underlined the multi-faceted nature of health research, requiring input from basic biological sciences, pharmaceutical technologies, clinical research), social sciences and public health and social ... ...

    Abstract Background: The recent COVID-19 pandemic dramatically underlined the multi-faceted nature of health research, requiring input from basic biological sciences, pharmaceutical technologies, clinical research), social sciences and public health and social engineering. Systems that could work across different disciplines would therefore seem to be a useful idea to explore. In this study we investigated whether metadata schemas and vocabularies used for discovering scientific studies and resources in the social sciences and humanities and in clinical research are similar enough to allow information from different source disciplines to be easily retrieved and presented together. Methods: As a first step a literature search was performed, exemplarily identifying studies and resources, in which data from social sciences and the humanities have been usefully employed or integrated with that from clinical research and clinical trials. In a second step a comparison of metadata schemas and related resource catalogues in ECRIN (European Clinical Research Infrastructure Network) and CESSDA (Consortium of European Social Science Data Archives) was performed. The focus was on discovery metadata, here defined as the metadata elements used to identify and locate scientific resources. Results: A close view at the metadata schemas of CESSDA and ECRIN and the basic discovery metadata as well as a crosswalk between ECRIN and CESSDA metadata schemas have shown that there is considerable resemblance between them. Conclusions: The resemblance could serve as a promising starting point to implement a common search mechanism for ECRIN and CESSDA metadata. In the paper four different options for how to proceed with implementation issues are presented.
    Keywords social sciences and humanities ; clinical research ; clinical trials ; metadata ; crosswalk ; cross-domains ; eng ; Science ; Q ; Social Sciences ; H
    Subject code 300
    Language English
    Publishing date 2023-10-01T00:00:00Z
    Publisher F1000 Research Ltd
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article ; Online: ECRIN – CESSDA strategies for cross metadata mappings in selected areas between life sciences and social sciences and humanities [version 2; peer review

    Christian Ohmann / Steve Canham / Katja Moilanen / Mari Kleemola / Maria Panagiotopoulou

    Open Research Europe, Vol

    1 approved, 2 approved with reservations]

    2023  Volume 3

    Abstract: Background The recent COVID-19 (Corona Virus Disease 2019) pandemic dramatically underlined the multi-faceted nature of health research, requiring input from basic biological sciences, pharmaceutical technologies, clinical research), social sciences and ... ...

    Abstract Background The recent COVID-19 (Corona Virus Disease 2019) pandemic dramatically underlined the multi-faceted nature of health research, requiring input from basic biological sciences, pharmaceutical technologies, clinical research), social sciences and public health and social engineering. Systems that could work across different disciplines would therefore seem to be a useful idea to explore. In this study we investigated whether metadata schemas and vocabularies used for discovering scientific studies and resources in the social sciences and in clinical research are similar enough to allow information from different source disciplines to be easily retrieved and presented together. Methods As a first step a literature search was performed, exemplarily identifying studies and resources, in which data from social sciences have been usefully employed or integrated with that from clinical research and clinical trials. In a second step a comparison of metadata schemas and related resource catalogues in ECRIN (European Clinical Research Infrastructure Network) and CESSDA (Consortium of European Social Science Data Archives) was performed. The focus was on discovery metadata, here defined as the metadata elements used to identify and locate scientific resources. Results A close view at the metadata schemas of CESSDA and ECRIN and the basic discovery metadata as well as a crosswalk between ECRIN and CESSDA metadata schemas have shown that there is considerable resemblance between them. Conclusions The resemblance could serve as a promising starting point to implement a common search mechanism for ECRIN and CESSDA metadata. In the paper four different options for how to proceed with implementation issues are presented.
    Keywords social sciences and humanities ; clinical research ; clinical trials ; metadata ; crosswalk ; cross-domains ; eng ; Science ; Q ; Social Sciences ; H
    Subject code 300
    Language English
    Publishing date 2023-12-01T00:00:00Z
    Publisher F1000 Research Ltd
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article ; Online: Assessment of a demonstrator repository for individual clinical trial data built upon DSpace [version 1; peer review

    Birol Tilki / Thomas Schulenberg / Steve Canham / Rita Banzi / Wolfgang Kuchinke / Christian Ohmann

    F1000Research, Vol

    2 approved]

    2020  Volume 9

    Abstract: Background: Given the increasing number and heterogeneity of data repositories, an improvement and harmonisation of practice within repositories for clinical trial data is urgently needed. The objective of the study was to develop and evaluate a ... ...

    Abstract Background: Given the increasing number and heterogeneity of data repositories, an improvement and harmonisation of practice within repositories for clinical trial data is urgently needed. The objective of the study was to develop and evaluate a demonstrator repository, using a widely used repository system (DSpace), and then explore its suitability for providing access to individual participant data (IPD) from clinical research. Methods: After a study of the available options, DSpace (version 6.3) was selected as the software for developing a demonstrator implementation of a repository for clinical trial data. In total, 19 quality criteria were defined, using previous work assessing clinical data repositories as a guide, and the demonstrator implementation was then assessed with respect to those criteria. Results: Generally, the performance of the DSpace demonstrator repository in supporting sensitive personal data such as that from clinical trials was strong, with 14 requirements demonstrated (74%), including the necessary support for metadata and identifiers. Two requirements could not be demonstrated (inability to incorporate de-identification tools in the submission workflow, lack of a self-attestation system) and three requirements were only partially demonstrated (ability to provide links to de-identification tools and requirements, incorporation of a data transfer agreement in system workflow, and capability to offer managed access through application on a case by case basis). Conclusions: Technically, the system was able to support most of the pre-defined requirements, though there are areas where support could be improved. Of course, in a productive repository, appropriate policies and procedures would be needed to direct the use of the available technical features. A technical evaluation should therefore be seen as indicating a system’s potential, rather than being a definite assessment of its suitability. DSpace clearly has considerable potential in this context and appears a suitable base for further exploration of the issues around storing sensitive data.
    Keywords Medicine ; R ; Science ; Q
    Subject code 020
    Language English
    Publishing date 2020-04-01T00:00:00Z
    Publisher F1000 Research Ltd
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: Assessment of a demonstrator repository for individual clinical trial data built upon DSpace [version 2; peer review

    Birol Tilki / Thomas Schulenberg / Steve Canham / Rita Banzi / Wolfgang Kuchinke / Christian Ohmann

    F1000Research, Vol

    2 approved]

    2020  Volume 9

    Abstract: Background: Given the increasing number and heterogeneity of data repositories, an improvement and harmonisation of practice within repositories for clinical trial data is urgently needed. The objective of the study was to develop and evaluate a ... ...

    Abstract Background: Given the increasing number and heterogeneity of data repositories, an improvement and harmonisation of practice within repositories for clinical trial data is urgently needed. The objective of the study was to develop and evaluate a demonstrator repository, using a widely used repository system (DSpace), and then explore its suitability for providing access to individual participant data (IPD) from clinical research. Methods: After a study of the available options, DSpace (version 6.3) was selected as the software for developing a demonstrator implementation of a repository for clinical trial data. In total, 19 quality criteria were defined, using previous work assessing clinical data repositories as a guide, and the demonstrator implementation was then assessed with respect to those criteria. Results: Generally, the performance of the DSpace demonstrator repository in supporting sensitive personal data such as that from clinical trials was strong, with 14 requirements demonstrated (74%), including the necessary support for metadata and identifiers. Two requirements could not be demonstrated (the ability to include de-identification tools and the availabiltiy of a self-attestation system) and three requirements were only partially demonstrated (ability to provide links to de-identification tools and requirements, incorporation of a data transfer agreement in system workflow, and capability to offer managed access through application on a case by case basis). Conclusions: Technically, the system was able to support most of the pre-defined requirements, though there are areas where support could be improved. Of course, in a productive repository, appropriate policies and procedures would be needed to direct the use of the available technical features. A technical evaluation should therefore be seen as indicating a system’s potential, rather than being a definite assessment of its suitability. DSpace clearly has considerable potential in this context and appears a suitable base for further exploration ...
    Keywords Medicine ; R ; Science ; Q
    Subject code 020
    Language English
    Publishing date 2020-06-01T00:00:00Z
    Publisher F1000 Research Ltd
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

    Full text online

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    Inter-library loan at ZB MED

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  5. Article ; Online: Classification of processes involved in sharing individual participant data from clinical trials [version 2; referees

    Christian Ohmann / Steve Canham / Rita Banzi / Wolfgang Kuchinke / Serena Battaglia

    F1000Research, Vol

    1 approved, 2 approved with reservations]

    2018  Volume 7

    Abstract: Background: In recent years, a cultural change in the handling of research data has resulted in the promotion of a culture of openness and an increased sharing of data. In the area of clinical trials, sharing of individual participant data involves a ... ...

    Abstract Background: In recent years, a cultural change in the handling of research data has resulted in the promotion of a culture of openness and an increased sharing of data. In the area of clinical trials, sharing of individual participant data involves a complex set of processes and the interaction of many actors and actions. Individual services and tools to support data sharing are becoming available, but what is missing is a detailed, structured and comprehensive list of processes and subprocesses involved and the tools and services needed. Methods: Principles and recommendations from a published consensus document on data sharing were analysed in detail by a small expert group. Processes and subprocesses involved in data sharing were identified and linked to actors and possible supporting services and tools. Definitions adapted from the business process model and notation (BPMN) were applied in the analysis. Results: A detailed and comprehensive tabulation of individual processes and subprocesses involved in data sharing, structured according to 9 main processes, is provided. Possible tools and services to support these processes are identified and grouped according to the major type of support. Conclusions: The identification of the individual processes and subprocesses and supporting tools and services, is a first step towards development of a generic framework or architecture for the sharing of data from clinical trials. Such a framework is needed to provide an overview of how the various actors, research processes and services could interact to form a sustainable system for data sharing.
    Keywords Medicine ; R ; Science ; Q
    Subject code 005
    Language English
    Publishing date 2018-04-01T00:00:00Z
    Publisher F1000 Research Ltd
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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    Inter-library loan at ZB MED

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  6. Article ; Online: Classification of processes involved in sharing individual participant data from clinical trials [version 1; referees

    Christian Ohmann / Steve Canham / Rita Banzi / Wolfgang Kuchinke / Serena Battaglia

    F1000Research, Vol

    1 approved, 2 approved with reservations]

    2018  Volume 7

    Abstract: Background: In recent years, a cultural change in the handling of data from research has resulted in the strong promotion of a culture of openness and increased sharing of data. In the area of clinical trials, sharing of individual participant data ... ...

    Abstract Background: In recent years, a cultural change in the handling of data from research has resulted in the strong promotion of a culture of openness and increased sharing of data. In the area of clinical trials, sharing of individual participant data involves a complex set of processes and the interaction of many actors and actions. Individual services/tools to support data sharing are available, but what is missing is a detailed, structured and comprehensive list of processes/subprocesses involved and tools/services needed. Methods: Principles and recommendations from a published data sharing consensus document are analysed in detail by a small expert group. Processes/subprocesses involved in data sharing are identified and linked to actors and possible services/tools. Definitions are adapted from the business process model and notation (BPMN) and applied in the analysis. Results: A detailed and comprehensive list of individual processes/subprocesses involved in data sharing, structured according to 9 main processes, is provided. Possible tools/services to support these processes/subprocesses are identified and grouped according to major type of support. Conclusions: The list of individual processes/subprocesses and tools/services identified is a first step towards development of a generic framework or architecture for sharing of data from clinical trials. Such a framework is strongly needed to give an overview of how various actors, research processes and services could form an interoperable system for data sharing.
    Keywords Medicine ; R ; Science ; Q
    Subject code 005
    Language English
    Publishing date 2018-02-01T00:00:00Z
    Publisher F1000 Research Ltd
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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    Inter-library loan at ZB MED

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  7. Article ; Online: Evaluation of repositories for sharing individual-participant data from clinical studies

    Rita Banzi / Steve Canham / Wolfgang Kuchinke / Karmela Krleza-Jeric / Jacques Demotes-Mainard / Christian Ohmann

    Trials, Vol 20, Iss 1, Pp 1-

    2019  Volume 10

    Abstract: Abstract Background Data repositories have the potential to play an important role in the effective and safe sharing of individual-participant data (IPD) from clinical studies. We analysed the current landscape of data repositories to create a detailed ... ...

    Abstract Abstract Background Data repositories have the potential to play an important role in the effective and safe sharing of individual-participant data (IPD) from clinical studies. We analysed the current landscape of data repositories to create a detailed description of available repositories and assess their suitability for hosting data from clinical studies, from the perspective of the clinical researcher. Methods We assessed repositories that enable storage, sharing, discoverability, re-use of the IPD and associated documents from clinical studies using a pre-defined set of 34 items and publicly available information from April to June 2018. For this purpose, we developed an indicator set to capture the maturity of the repositories’ procedures and their suitability for the hosting of IPD. The indicators cover guidelines for data upload and data de-identification, data quality controls, contracts for upload and storage, flexibility of access, application of identifiers, availability of metadata, and long-term preservation. Results We analysed 25 repositories, from an initial set of 55 identified as possibly relevant. Half of the included repositories were generic, i.e. not limited to a specific disease or clinical area and 13 were launched in the last 8 years. The sample was extremely heterogeneous and included repositories developed by research funders, infrastructures, universities, and editors. All but three repositories do not apply a fee for uploading, storage or access to data. None of the repositories completely demonstrated all the items included in the indicator set, but three repositories (Dryad, Drum, EASY) met – fully or partially – all items. Flexibility of data-access modalities appears to be limited, being lacking in half of the repositories. Conclusions Our evaluation, though often hampered by the lack of sufficient information, can help researchers to find a suitable repository for their datasets. Some repositories are more mature because of their support for clinical dataset preparation, ...
    Keywords Clinical studies ; Data sharing ; Data repositories ; Individual-participant data ; Metadata ; Medicine (General) ; R5-920
    Subject code 302
    Language English
    Publishing date 2019-03-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  8. Article ; Online: An iterative and interdisciplinary categorisation process towards FAIRer digital resources for sensitive life-sciences data

    Romain David / Christian Ohmann / Jan-Willem Boiten / Mónica Cano Abadía / Florence Bietrix / Steve Canham / Maria Luisa Chiusano / Walter Dastrù / Arnaud Laroquette / Dario Longo / Michaela Th. Mayrhofer / Maria Panagiotopoulou / Audrey S. Richard / Sergey Goryanin / Pablo Emilio Verde

    Scientific Reports, Vol 12, Iss 1, Pp 1-

    2022  Volume 11

    Abstract: Abstract For life science infrastructures, sensitive data generate an additional layer of complexity. Cross-domain categorisation and discovery of digital resources related to sensitive data presents major interoperability challenges. To support this ... ...

    Abstract Abstract For life science infrastructures, sensitive data generate an additional layer of complexity. Cross-domain categorisation and discovery of digital resources related to sensitive data presents major interoperability challenges. To support this FAIRification process, a toolbox demonstrator aiming at support for discovery of digital objects related to sensitive data (e.g., regulations, guidelines, best practice, tools) has been developed. The toolbox is based upon a categorisation system developed and harmonised across a cluster of 6 life science research infrastructures. Three different versions were built, tested by subsequent pilot studies, finally leading to a system with 7 main categories (sensitive data type, resource type, research field, data type, stage in data sharing life cycle, geographical scope, specific topics). 109 resources attached with the tags in pilot study 3 were used as the initial content for the toolbox demonstrator, a software tool allowing searching of digital objects linked to sensitive data with filtering based upon the categorisation system. Important next steps are a broad evaluation of the usability and user-friendliness of the toolbox, extension to more resources, broader adoption by different life-science communities, and a long-term vision for maintenance and sustainability.
    Keywords Medicine ; R ; Science ; Q
    Language English
    Publishing date 2022-12-01T00:00:00Z
    Publisher Nature Portfolio
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

    Full text online

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