期刊
LEARNING HEALTH SYSTEMS
卷 -, 期 -, 页码 -出版社
WILEY
DOI: 10.1002/lrh2.10365
关键词
biotechnology; International Organization for Standardization; provenance information; standardization
Open and practical exchange, dissemination, and reuse of specimens and data have become essential for life sciences research. The quality of the data and findings rely on the quality of samples, experimental methods, and data analysis, which necessitate comprehensive and precise documentation. Current information on sample and data provenance is often sparse or incomplete, and lacks a uniform framework for interoperability. Additionally, the collection and sharing of specimens require consideration of benefit sharing and regulatory compliance. This publication presents a standardization effort to provide trustworthy documentation of data lineage and specimens, and invites experts to contribute.
Open and practical exchange, dissemination, and reuse of specimens and data have become a fundamental requirement for life sciences research. The quality of the data obtained and thus the findings and knowledge derived is thus significantly influenced by the quality of the samples, the experimental methods, and the data analysis. Therefore, a comprehensive and precise documentation of the pre-analytical conditions, the analytical procedures, and the data processing are essential to be able to assess the validity of the research results. With the increasing importance of the exchange, reuse, and sharing of data and samples, procedures are required that enable cross-organizational documentation, traceability, and non-repudiation. At present, this information on the provenance of samples and data is mostly either sparse, incomplete, or incoherent. Since there is no uniform framework, this information is usually only provided within the organization and not interoperably. At the same time, the collection and sharing of biological and environmental specimens increasingly require definition and documentation of benefit sharing and compliance to regulatory requirements rather than consideration of pure scientific needs. In this publication, we present an ongoing standardization effort to provide trustworthy machine-actionable documentation of the data lineage and specimens. We would like to invite experts from the biotechnology and biomedical fields to further contribute to the standard.
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