gms | German Medical Science

Research projects that are based on clinical data require an application and approval process before access is granted [1]. In most institutions, information regarding individual process steps are communicated via e-mail or paper-based. Additionally, the processes for application approval of several institutions are not harmonized. A static process, which maps the steps of every medical center, cannot be implemented in one platform. Within MIRACUM (Medical Informatics in Research and Medicine) as a part of the Medical Informatics Initiative [2], [3], a customizable platform called ProSkive for submitting and managing applications is to be designed as an open source solution to fit this purpose.

The initial step of this process is the submission of a project proposal for data usage to request the datasets needed. This application is sent to several medical centers, which usually belong to hospitals. There, the application processing includes several steps. Once the application is submitted, it is checked for formal and content-related correctness before it is forwarded to a committee for evaluation. This may be for example a Use and Access Committee. In case of approval by all committees, further formal and legal steps are necessary before providing clinical data.

Due to the heterogeneous process structure at the individual centers, particular emphasis should be placed on individually customizable processes. The main objective of this publication is to evaluate whether an adaptable process can be developed and implemented in form of a customizable platform. A concept of an adaptable process and results of the implementation of a first prototype are presented.

The initial application approval process in the field of biobanks was adapted through the exchange with experts and implemented within a prototype comprising a static application process [4]. The search for existing solutions to this problem yielded entirely commercial ones.

Based on the experiences of ProSkive Bio [4] and expert interviews within MIRACUM, core elements for the application forms were detected and the application approval process was included in the conceptual design of the customizable platform.

The joint exchange between the MIRACUM partners resulted in a first model of an adaptable process that is divided into several groups and ends with the release of the data or rejection of the application. Examples of these groups are e.g. applicants, administrative offices or an evaluation committee, while a user can be assigned to one or more groups. Cyclical or parallel processes should also be representable and configurable independently by the site and although a general process framework was defined. ProSkive allows for site-specific changes in these single process steps.

This first prototype covers the initial step of the designed process, which yields a first level of assistance. However, the prototype is still limited. The remaining parts of the approval process have to be managed manually.

After the rollout of the prototype, feedback from the partner sites was collected and analyzed. Based on this feedback, missing steps of the process were developed. In the future, the entire process will be implemented using a feedback-driven development.

The authors declare that they have no competing interests.

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