Digital Clinical Study Process

Abstract

This master thesis researches on clinical trial environment, clinical research informatics and an integrated data exchange by aiming to detect opportunities and challenges in those three fields. Thus, after a systematic literature review in order to research the state of the art in clinical research including the research phases, processes and challenges and opportunities, the clinical research informatics (CRI) is focused itself. Herein, the digitalization in clinical research is the motivator within resulting challenges and opportunities in CRI itself, what was researched next. Furthermore, qualitative research resources could be found and used within this specific, evolving field of CRI, where the COVID19 pandemic was elaborated lastly. Next detailing level was the data exchange within the CRI, where first the meaning of data was evolved. After researching on the elements for data quality and data-centric view, a CRI systems overview is given from the current clinical research environment. The size of this landscape is enormous, what makes the usage of frameworks and standards essential for interoperability. After stating the research gap and building the own framework, a qualitative summery is given followed by the research design and used interview methodology. The presentation of the data analysis method within the corresponding codes, the research results are presented followed by a conclusion and outlook for the future work.