Concept for a Basic ISO 14721 Archive Information Package for Clinical Studies

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.