Concept for a Basic ISO 14721 Archive Information Package for Clinical Studies Matthias LÖBE a,1 , Alessandra KUNTZ b , Christian HENKE b , Frank MEINKE a , Ulrich SAX b,c and Alfred WINTER a a Institute for Medical Informatics, Statistics and Epidemiology (IMISE), University of Leipzig, Germany b Department of Medical Informatics at the University Medical Center Göttingen, Germany c Campus-Institute of Data Science (CIDAS), Göttingen, Germany ORCiD ID: Matthias Löbe 0000-0002-2344-0426, Alessandra Kuntz 0000-0002-8259- 2577, Christian Henke 0000-0002-4541-4018, Frank Meineke 0000-0002-9256-7543, Ulrich Sax 0000-0002-8188-3495 Abstract. Secondary use of medical data for research is desirable for intrinsic, ethical and financial reasons. In this context, the question becomes relevant as to how such datasets are to be made accessible to a larger target group in the long term. Typically, datasets are not extracted ad hoc from the primary systems, because they are processed qualitatively (FAIR data). Special data repositories are currently being built for this purpose. This paper examines the requirements for the reuse of clinical trial data in a data repository utilizing the Open Archiving Information System (OAIS) reference model. In particular, a concept for an Archive Information Package (AIP) is developed with the central focus on a cost-effective trade-off between the effort of creation for the data producer and the comprehensibility of the data for the data consumer. Keywords. Data sharing, Research Data Management, OAIS, ISO 14721, Clinical trials, Archiving, Data repositories, Data reuse, FAIR 1. Introduction Data sharing, the reuse of data once collected for further research purposes, has moved from an altruistic attitude of individual researchers to an obligation of many funders or scientific publishers in recent years. Data sharing makes sense for scientific, ethical, and resource reasons. Nevertheless, it is not widely practiced because, first, it involves a significant effort for the data provider that is currently not compensated, second, there is a lack of data repositories for permanent storage and legally secure access (particularly for sensitive personal health data), and third, there are no widely accepted ideas about which data structures are essential for data recipients in complex research projects. In the field of medical research, local research data centers are currently being set up in Germany that will have the technical (hardware, storage space, network 1 Corresponding Author: Matthias Löbe, Institut für Medizinische Informatik, Statistik und Epidemiologie, Universität Leipzig, Härtelstraße 16-18, 04107 Leipzig, Germany; E-mail: matthias.loebe@imise.uni-leipzig.de. Caring is Sharing – Exploiting the Value in Data for Health and Innovation M. Hägglund et al. (Eds.) © 2023 European Federation for Medical Informatics (EFMI) and IOS Press. This article is published online with Open Access by IOS Press and distributed under the terms of the Creative Commons Attribution Non-Commercial License 4.0 (CC BY-NC 4.0). doi:10.3233/SHTI230247 721