gms | German Medical Science

Background: The protection of sensitive data against unauthorized access is especially important in healthcare and medical research. Not only medical data but also identifying administrative data in medical research projects must be managed and protected. While Clinical Data Management Systems (CDMS) are well established in clinical trial data management, digitalization of study participant management is still underway. A Study Participant Management System (SPMS) was developed by the Department of Medical Informatics at the University Medical Center Göttingen as web application to manage administrative data in single-site clinical trials [1]. To expand the SPMS for the use in multi-site studies, however, stronger and specific regulations for participant data access are required to meet data protection requirements. Therefore, a comprehensive concept to control data access in multi-site clinical trials is currently developed. In this context, access control mechanisms were examined as a fundamental component for secure information sharing in the SPMS application.

Methods: Existing state-of-the-art access control models and architectures were investigated to meet access control requirements for a multi-site SPMS in general and for possible technical solutions. Only technical solutions were considered that fit into the software stack of the SPMS, which was implemented as a web application with the use of Java Enterprise Edition (Java EE) technology. Based on different usage scenarios specific for actors and locations, an authorization concept was developed. In particular, the functions and workflows required to process data were described. Furthermore, specific user roles were identified, and their access rights to different study participants and data items were determined.

Results: An access control architecture capable of providing data access control for a multi-center SPMS has been defined using a combination of Role-Based Access Control (RBAC) [2], [3] and Attribute-Based Access Control (ABAC) [4] models. To establish the architecture, tasks and necessary access permissions of each user role (e.g., principal investigator, clinical trial assistant) were described by collecting respective use cases for study participant data management. The authorization concept was implemented with the Spring Security framework [5], which provides comprehensive security services for Java EE-based software applications. Spring Expression Language (SpEL) [6] expressions allowed to implement fine-grained access controls. The implementation of the authorization concept was tested with JUnit [7] integration test cases to reduce the risk of software errors.

Conclusion: Strict regulations must be implemented to ensure that only authorized users can access sensitive data in multi-site studies. Data access requirements depend on software architecture, data model, and business requirements and cannot be easily simplified. In each case, the complexity should be kept as low as possible in order to minimize efforts. With a well-adjusted fine-grained access control, it is more likely to prevent breaches and improve data protection of participant management in multi-site studies.

The authors declare that they have no competing interests.

The authors declare that an ethics committee vote is not required.