Background Clinical trial registries increase transparency in medical research by making information and results of planned, ongoing, and completed studies publicly available. However, the registration of clinical trials remains a time-consuming manual task complicated by the fact that the same studies often need to be registered in different registries with different data entry requirements and interfaces. Objective This study investigates how Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) may be used as a standardized format for exchanging and storing clinical trial records. Methods We designed and prototypically implemented an open-source central trial registry containing records from university hospitals, which are automatically exported and updated by local study management systems. Results We provided an architecture and implementation of a multisite clinical trials registry based on HL7 FHIR as a data storage and exchange format. Conclusions The results show that FHIR resources establish a harmonized view of study information from heterogeneous sources by enabling automated data exchange between trial centers and central study registries.

Background The consent management is an essential component for supporting the implementation of consents and withdrawals and thus, the realisation of patient’s rights. In MIRACUM, one of the four consortia of the Medical Informatics Initiative (MII), ten university hospitals intend to integrate the generic Informed Consent Service® (gICS) in their Data Integration Center (DIC). To provide a tool that supports the local workflows of the MIRACUM sites, the gICS should be improved. Methods We used three standardised questionnaires with 46 questions to elicit requirements from the ten sites. Each site answered the questions from the current and the desired future perspective. This made it possible to understand the individual processes at each site and it was possible to identify features and improvements that were generally necessary. Results The results of the survey were classified according to their impact on the gICS. Feature requests of new functionalities, improvements of already implemented functionalities and conceptual support for implementing processes were identified. This is the basis for an improved gICS release to support the ten sites’ individual consent management processes. Conclusions A release plan for the feature requests and improvements was coordinated with all sites. All sites have confirmed that the implementation of these features and enhancements will support their software-based consent management processes.

Background Clinical trials are the gold standard for advancing medical knowledge and improving patient outcomes. For their success, an appropriately sized cohort is required. However, patient recruitment remains one of the most challenging aspects of clinical trials. Information technology (IT) support systems—for instance, patient recruitment systems—may help overcome existing challenges and improve recruitment rates, when customized to the user needs and environment. Objective The goal of our study is to describe the status quo of patient recruitment processes and to identify user requirements for the development of a patient recruitment system. Methods We conducted a web-based survey with 56 participants as well as semistructured interviews with 33 participants from 10 German university hospitals. Results We here report the recruitment procedures and challenges of 10 university hospitals. The recruitment process was influenced by diverse factors such as the ward, use of software, and the study inclusion criteria. Overall, clinical staff seemed more involved in patient identification, while the research staff focused on screening tasks. Ad hoc and planned screenings were common. Identifying eligible patients was still associated with significant manual efforts. The recruitment staff used Microsoft Office suite because tailored software were not available. To implement such software, data from disparate sources will need to be made available. We discussed concrete technical challenges concerning patient recruitment systems, including requirements for features, data, infrastructure, and workflow integration, and we contributed to the support of developing a successful system. Conclusions Identifying eligible patients is still associated with significant manual efforts. To fully make use of the high potential of IT in patient recruitment, many technical and process challenges have to be solved first. We contribute and discuss concrete technical challenges for patient recruitment systems, including requirements for features, data, infrastructure, and workflow integration.

BACKGROUND Clinical trial registries increase transparency in medical research by making information and results of planned, ongoing, and completed studies publicly available. However, the registration of clinical trials remains a time-consuming manual task complicated by the fact that often the same studies need to be registered in different registries with different data entry requirements and interfaces. OBJECTIVE Study registration can be improved by using a common standard across study registries to represent study information and alleviate its exchange. We investigate the use of Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) for this purpose. METHODS Design and prototypically implement an open-source central trial registry containing records from university hospitals which are automatically exported and updated by local study management systems. RESULTS We provide an architecture and implementation of a multi-site clinical trials registry based on HL7 FHIR as a data storage and exchange format. CONCLUSIONS The results show that FHIR resources establish a harmonized view of study information from heterogeneous sources by enabling automated data exchange between trial centers and central study registries.

BACKGROUND Clinical trials are the gold standard for advancing medical knowledge and improving patient outcomes. For their success, an appropriately sized cohort is required. However, patient recruitment remains one of the most challenging aspects of clinical trials. IT support -- patient recruitment systems -- may help to overcome existing challenges and improve recruitment rates, when fitted to the user needs and environment. OBJECTIVE The goal of our research is to describe the status quo of patient recruitment processes and identify user requirements for the development of a patient recruitment system. METHODS We conducted an online survey with 56 participants and semi-structured interviews with 33 participants from ten German university hospitals. RESULTS We report the recruitment procedures and challenges of ten university hospitals. The recruitment process is influenced by diverse factors, such as the ward, the use of software, and the study inclusion criteria. Overall, clinical staff seems more involved in patient identification, while research staff focuses on screening tasks. Ad-hoc as well as planned screening is common. Identifying eligible patients is still associated with significant manual efforts. Recruitment staff use Office applications since no tailored software is available. For such software, data from disparate sources will need to be made available. We contribute and discuss concrete technical challenges for patient recruitment systems, including requirements for features, data, infrastructure, and workflow integration, to support to development of a successful system. CONCLUSIONS To make use of the high potential of IT for patient recruitment, many technical and process challenges still have to be solved. Based on their recruitment workflows and experience, our participants identified requirements, which a successful patient recruitment system has to fulfill. Prospective users should be involved in the subsequent design and development steps.