Quelle: Eigene Darstellung; Freepik
On June 14, 2023, data stewards, RDM responsible persons and RDM interested persons of RWTH Aachen University met again for the regular open meeting of the RDM network online via Zoom. This time, an exciting lecture on “RDM in clinical studies” awaited the participants.
Science Speed Dating to Get To Know Each Other
To get to know each other, exchange ideas and network, the usual science speed dating session was held. This time, the participants exchanged views in two five-minute breakout sessions on the questions of whether personal data is worked with, how sensitive and confidential the respective data is, and what special protective measures are taken.
Lecture: Data Management in Medical Studies
An introduction to RDM in clinical trials was given by Jan Wienströer and Josua Welter from the data management team of the Institute for Medical Informatics (IMI) at the University Hospital of RWTH Aachen (UKA). They reported from their cooperation with the Center for Translational & Clinical Research (CTC-A) to support data management in clinical trials. In addition to performing professional data management as active participation in projects, the team also supports researchers through consulting, self-service offerings, and software development.
The key challenge when working in the clinical field is to ensure the rights, safety and well-being of patients. Therefore, research as well as data management in general are subject to strict regulatory requirements here (e.g. German Medicines Act, DSGVO, Good Clinical Practice) combined with a high documentation effort. The data management team achieves this through regulated quality management, quality standards and, in particular, small-steps, binding work instructions in the form of standard operating procedures (SOPs).
From planning, setup and operation to completion, clinical studies are supervised and accompanied by the team. Data management plans also play an important role in RDM in clinical studies. They are considered the central document in which all RDM activities are recorded. For this purpose, the team has defined a comprehensive template for the clinical area, which is adapted in coordination with the study management and filled in together with the researchers.
The data management team is well positioned to meet the highest quality standards in drug trials. However, it is challenging that the SOPs have to be continuously adapted and improved. Also, the studies to be managed are very different, and the very high quality management requirements from drug studies cannot be transferred 1:1 to smaller studies in other contexts. This would be beyond the scope of effort and funding. Thus, a sense of proportion must be used to reduce the maximum package according to the applicable framework, resulting in a data management plan that supports research, ensures data quality, and meets all regulatory requirements.
The RDM team sincerely thanks you for the exciting lecture and exchange and looks forward to seeing you again.
The Next Open Meeting of the RDM Network – Save the Date
Lunch together
Date: August 16, 2023
Time: 12 noon
Location: To be announced
Learn More
If you also want to become a part of the RDM network at RWTH, then subscribe to the mailing list “DataStewards@RWTH”.
If you have any questions about the RDM network or RDM in general, just write a message to the IT-ServiceDesk. The RDM Team looks forward to hearing from you.
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Responsible for the content of this article are Lina-Louise Kaulbach and Ute Trautwein-Bruns.
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