ISO 23494: Biotechnology – Provenance Information Model for Biological Specimen and Data R. Wittner & P. Holub & H. Müller BBMRI-ERIC, AUT J. Geiger IBDW, DE C. Goble & S. Soiland-Reyes University of Manchester, UK L. Pirredu & F. Frexia & C. Mascia & G. Zanetti CRS4, IT E. Fairweather KCL, UK H. Nakae JMAC, JPN C. Strambio & D. Grunwald University of Massachusetts, US J. Swedlow & J. Moore University of Dundee, UK Abstract Exchange of research data and samples in biomedical re- search has become a common phenomenon demanding for their effective quality assessment. At the same time, several reports address reproducibility of research, where history of biological samples (acquisition, processing, transportation, storage, and retrieval) and data history (data generation and processing) deﬁnes their ﬁtness for purpose, and hence their quality. The project aims at developing a comprehensive W3C PROV based provenance information standard intended for the biomedical research domain. The standard is being devel- oped by the working group 5 ("data processing and integra- tion") of the ISO (International Standardisation Organisation) technical committee 276 "biotechnology". The outcome of the project will be published in parts as international stan- dards or technical speciﬁcations. The poster informs about the goals of the standardisation activity, presents the proposed structure of the standards, brieﬂy describes its current state and outlines its future development and open issues. 1 Introduction Research in life sciences has undergone signiﬁcant changes during recent years, evolving away from individual projects conﬁned to small research groups to transnational consortia covering a wide range of techniques and expertise. At the same time several reports addressing the quality of research papers in life sciences uncovered an alarming number of ill- founded claims. The reasons for the deﬁciencies are diverse, with insufﬁcient quality and documentation of the biological material used being the major issue [1,4,5]. Hence there is ur- gent need for standardized and comprehensive documentation of the whole workﬂow from the collection, generation, pro- cessing and analysis of the biological material to data analysis and integration. The PROV [6] family of documents serves as a current standard for provenance information used to describe the history of an object. On the other hand, as discussed in the results from EHR4CR and TRANSFoRm projects [2,3], its implementation for the biotechnology domain and the ﬁeld of biomedical research in particular is still a pending issue. To address this, the International Standardisation Organisation (ISO) initiated the development of a Provenance Information Model for Biological Specimen and Data standard deﬁning the requirements for interoperable, machine-actionable doc- umentation intended to describe the complete process chain from the source of biological material through its processing, analysis, and all steps of data generation and data processing to ﬁnal data analysis. The standard is intended for implementers and suppliers of HW/SW tools used in biomedical research (e.g. lab automa- tion devices or analytical devices used for research purposes) and also for organisations adopting generated provenance (e.g. to require or use standardised tools). 2 Goals of the Standard and Its Structure The main goals of the standard are to (a) enable effective assessment of quality and ﬁtness for purpose of the objects provided, such as biological material and data; (b) support reproducible research by exacting the capture of all relevant information; (c) track error propagation within scientiﬁc re- sults; (d) track the source of biological material in order to prevent fabrication of data and enabling notiﬁcation of sub- jects in case of relevant incidental ﬁndings; (e) propagate withdrawal of or changes to an informed consent along the process chain. The proposed structure of the standard reﬂects the inten- tion