The DZHK Clinical Study Units are made up of one to three rooms provided by the hospitals. The DZHK has equipped these rooms with standardised devices for cardiovascular diagnostics. For the DZHK’s own biomaterial sample collection, standardised equipment for the ascertainment and storage of samples has also been acquired.
Whether all devices are present and operated in accordance with DZHK regulations was reviewed in the internal audit. A further focus was the verification of correct data entry in the central DZHK data management systems. The DZHK conducts large multi-centre studies, which require standardised procedures in patient recruitment and sample material collection across all clinical DZHK sites.
“The DZHK has invested a lot of time and money in setting up these research units. Now, we also want to know whether they are operating to our satisfaction”, says DZHK Managing Director Joachim Krebser. According to him, setting up rooms that are operated following guidelines of an external organisation in 17 different hospitals was not an easy task and required considerable coordination and time.
Beside the sheer technical features, the DZHK Clinical Study Units are significant in another way. “With these units, we are literally giving clinical cardiovascular research more room”, says Prof. Frank Edelmann of Berlin Charité, Campus Virchow. The cardiologist oversees several DZHK studies there and knows from personal experience that clinical research is just a sideline in many hospitals. “In the DZHK Clinical Study Units, our study staff can concentrate fully on the studies. Patient care has no business here.”
According to Edelmann, this increases the quality of data and the motivation of the staff. The outcome is high-quality clinical research in the DZHK – for the benefit of cardiovascular patients.