Requirements for Biobank Information Management Systems - Considerations in the evaluation and selection of a hospital based BIMS for human research

Abstract

In the light of the reproducibility crisis in biomedical research, international initiatives and guidelines, and increasingly also regulations and laws, emphasize the need for exhaustive, reliable and interoperable documentation as well as for secure data management with full audit trail in research. This applies in particular to the management of samples in biobanks, since missing or incorrect information about the sample characteristics can call into question the validity of analysis results. The high number of pre-analytical factors requiring documentation as well as the management of the samples themselves can only be implemented with the use of validated software solutions, not only from a practical point of view in case of growing sample collections. In the case of hospital-based biobanks, an important prerequisite for efficient documentation with reduction of manual data entry steps is a deep integration into the system landscape of the hospital with its numerous source systems with regard to sample and patient information. For the successful selection and implementation of a suitable biobank information management system, the development of detailed user requirements and use cases is crucial. This work provides sample use cases and generic user requirements for the whole sample life cycle in a hospital-based biobank, based on the concept of a sample management software for human research at a Swiss university hospital. Based on 5 different biobanks concerning liquid, tissue and bacteriological samples, illustrated process descriptions with regard to the data flow were created and generic sample user requirements were formulated, taking into account national and international recommendations and stipulations. These can be a valuable starting point for the preparation of user requirements in other biobanks

Datum der Bewilligung	2020
Originalsprache	Englisch
Gradverleihende Hochschule	Medizinische Universität Graz
Betreuer/-in	Karine Sargsyan (Betreuer*in)