study register
A study register provides an up-to-date and user-orientated overview of trials. The freely available information in the national and international study registers supports transparency in medical research.
The prerequisite for a UKSH-wide clear presentation of all studies and the associated recruitment is the registration of as many studies as possible in one portal. SKFIT has been instrumental in supporting the Medical Data Integration Centre (MeDIC) in creating a study register for all study activities within the UKSH.
The UKSH study register is mandatory for all clinical studies at the UKSH and is currently managed by the MeDIC. The information on studies is continuously supplemented via the primary registers. By assigning the studies to the study centres, it is possible to trace the content back to the websites of the individual clinics or study centres. The visibility of research at the UKSH and the UzL is increased and patients and other interested parties can view current studies.
study management
Cooperation with study centres has shown that managing the general processes of a study is so complex that local ‘IT workarounds’ reach their limits. A generic procedure was developed using CentraXX software, which can be used to support different processes at different centres very effectively. CentraXX can therefore be used to map all the information required to manage studies.
Study documentation using a CTMS (Clinical Trial Management System)
SKFIT offers its customers a complete clinical study management system for clinical studies that are not subject to the AMG and MPG, which supports the study manager and the study team in the planning, preparation, implementation and provision of data for the evaluation of clinical studies. The main task is the structured recording and storage of data, which forms the basis for study data storage, reporting and analysis. In addition, plausibility checks, data backup, access controls, randomisation and other functionalities are provided. The solutions are suitable for both mono-centre and multi-centre studies within Germany.
