GMS Medizin – Bibliothek – Information (Dec 2023)
Castellum – eine datenschutzkonforme Webanwendung für das Management von Proband:innen der wissenschaftlichen Forschung
Abstract
Strict requirements apply to the administration of participants in regulated clinical trials. Depending on the study, medicines acts, the Medical Device Law Implementation Act as well as the guidelines and standards of good clinical practice must be complied with or implemented. Even outside the clinical research area, there are clear requirements regarding the administration of participants and the processing of their personal data, particularly in the human sciences, at the latest since the European Data Protection Regulation came into force in 2018. In order to meet these requirements, the Castellum software has been developed at the Max Planck Institute for Human Development since 2016 and has been used successfully since May 2020. Castellum is a turnkey open-source web application for the data protection-compliant management of participants and their data.The use of Castellum has so far been particularly successful for institutions conducting research in the humanities that carry out several studies in parallel, that want to proactively recruit participants from an internal pool of interested persons after they have given their consent (recruitment consent), and that generate data when dealing with these participants.The rules that apply to the clinical research area have not been a priority in the development of Castellum to date. The reason is that Castellum has not yet been used in the clinical research area and thus there was no need to adapt the system to the rules. However, medical research institutions have expressed interest in Castellum in the recent past. On the one hand, this may be due to the fact that no comparable open-source project exists. On the other hand, Castellum was explicitly designed to be flexible and expandable enough to be adaptable to the workflows and processes of other research institutions. Since Castellum is subject to the AGPL licence, the software may be used free of charge without restrictions.The main focus during development was on compliance with the General Data Protection Regulation and other aspects of general IT security. For this reason, we believe it is possible that Castellum is also suitable for contexts that work with highly sensitive data, such as medical research institutions. This opens up a new space for discussion: How can Castellum be used in the clinical regulated field? Which conditions of regulated research studies does Castellum currently fulfil and which not yet? What does Castellum need in order to implement the guidelines on good clinical practice? Which adaptations and extensions are necessary for Castellum to comply with the regulations, rules and laws of regulated studies?We are very interested in introducing Castellum in the clinical research field. From our point of view, it is important to examine within a cooperative process for which purposes Castellum is already qualified in the clinical research area and which adaptations still need to be implemented. We are striving to jointly identify suitable measures to validate Castellum, especially for regulated clinical research studies.This article first presents what Castellum is currently able to offer. It then focuses on a possible expansion of the software in the clinical research area.
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