Toward a common standard for data and specimen provenance in life sciences

Abstract

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.

Keywords: International Organization for Standardization; biotechnology; provenance information; standardization.

FIGURE 1

An overview of the provenance chain. A sample obtained from a donor (or other sources) is created and an initial set of provenance information (PI) is generated. As that sample moves through time and space, is processed and/or analyzed, additional provenance data are appended to the provenance chain for each new item. The chain can be extended as a complete unit of later stages of provenance or use unique identifiers to refer to early stages of provenance data. The figure cited from.