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.

BBMRI ERIC Graz Austria

Biocomplexity Institute Indiana University Bloomington Indiana USA

Biological Resource Center of Institut Pasteur Paris France

Biosystems and Biomaterials Division NIST Gaithersburg Maryland USA

Canadian Primary Care Sentinel Surveillance Network Department of Family Medicine Queen's University Kingston Ontario Canada

Centre for Gene Regulation and Expression and Division of Computational Biology School of Life Sciences University of Dundee Dundee UK

CRS4 Center for Advanced Studies Research and Development in Sardinia Pula Italy

Department of Biomedicine University of Basel Basel Switzerland

Department of Computer Science University of Manchester Manchester UK

Department of Social Statistics School of Social Sciences University of Manchester Manchester UK

EMBL's European Bioinformatics Institute Cambridge UK

Flanders Marine Institute EMBRC Belgium Ostend Belgium

German BioImaging Gesellschaft für Mikroskopie und Bildanalyse e 5 Konstanz Germany

Heidelberg Institute for Theoretical Studies Heidelberg Germany

Independent consultant

Informatics Institute University of Amsterdam Amsterdam The Netherlands

INSERM Institut National de la Sante et de la Recherche Medicale Paris France

Institute of Computer Science and Faculty of Informatics Masaryk University Brno Czechia

Interdisciplinary Bank of Biomaterials and Data Würzburg Würzburg Germany

ITTM S A Esch sur Alzette Luxembourg

Japan bio Measurement and Analysis Consortium Tokyo Japan

King's College London London UK

Medical University Graz Graz Austria

National Institute of Standards and Technology Gaithersburg Maryland USA

Ontario Institute for Cancer Research Toronto Ontario Canada

Plentzia Marine Station University of the Basque Country EMBRC Spain Bilbao Spain

Program in Molecular Medicine University of Massachusetts Chan Medical School Worcester Massachusetts USA

SCI STI MM École Politechnique Fédérale de Lausanne Lausanne Switzerland

Standards Council of Canada Ottawa Ontario Canada

University of Klagenfurt Klagenfurt Austria

University of Southampton Southampton UK

US Department of Agriculture Washington District of Columbia USA

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