Study Center
Study Center
The Study Center of the German Heart Institute Berlin supports scientists and scientifically active physicians in administrative and organizational tasks and coordinates the research projects. This creates the necessary freedom for the researchers to concentrate fully on their scientific tasks.
The medical director of the study center is Sabine Hübler. Her team includes several study coordinators, a librarian, a statistician and student assistants.
In the run-up to the study, the team's tasks include checking the legal classification of the project, assisting with the preparation of application documents for submission to official bodies, and preparing grant applications, right through to drafting or monitoring contracts, including budget preparation and monitoring.
To ensure that the study runs smoothly and in accordance with the study protocol, the study center organizes information events during the course of a study, coordinates examinations of patients and documents the required data in accordance with the protocol. After completion of the study, statistical analysis and publication of the data obtained is required, predominantly in English.
DZHK Study Center
The German Center for Cardiovascular Research (DZHK) is a publicly funded institution that aims to make new research results available to all patients as quickly as possible. It also aims to improve therapies as well as diagnostics and prevention of cardiovascular diseases. To this end, the institution promotes clinical studies.
As one of the DZHK clinics at the Berlin site and as a certified "DZHK Study Center", the German Heart Institute Berlin initiates clinical studies itself (https://www.dhzb.de/de/abteilungen/herz_thorax_und_gefaesschirurgie/forschung/dzhk/), which are financed by the DZHK, and also participates in various other studies of the DZHK.
External and internal quality assurance
All hospitals licensed according to § 108 SGB V are required by law to document their treatment in various service areas (e.g. cardiac catheter interventions, valve or bypass operations) and to make the results available to an external inspection body. This so-called "external inpatient quality assurance" enables nationwide comparability between hospitals.
The staff of the study center, in close cooperation with the information technology department, ensure complete and correct data collection as well as timely delivery of the data. In addition, the German Heart Institute Berlin also participates in other quality assurance measures on a voluntary basis. For this purpose, data are delivered to various external registries, e.g. the German Aortic Valve Registry and the European Registry for Patients with Mechanical Circulatory Support (EUROMACS).
In addition, the study center maintains in-house databases on various topics (e.g., transplantation, artificial heart implantation, valve replacement, aortic surgery). Data that routinely occur before, during, and after surgery are systematically collected. In addition to collecting data for internal quality assurance, these data are also available for research upon request. This data is passed on in compliance with all data protection regulations.