Scientific Infrastructure for Clinical Studies

The more uniform the data from clinical studies, the more valuable they will be for ongoing and future research projects. The DZHK therefore needs common regulations, standards and implementation guidelines as well as a central IT infrastructure for its multicentre studies. This is the only way to ensure that all data and biomaterials are collected, processed and archived in the same way. In the first two years of its existence, the DZHK undertook a lengthy process of harmonisation and standardisation to create such structures. This means that data from different DZHK studies can be pooled and evaluated again and again with different scientific objectives.

Over the years to come, a unique nationwide ‘treasure trove’ of cardiovascular data will be produced that will allow future generations of researchers to search for causes and potential treatments for cardiovascular diseases using methods which are as yet unknown to us.

Uniform Collection of Clinical Data

Because data collected within the scope of DZHK studies are intended for use across multiple studies, the DZHK’s clinical researchers first had to agree on a uniform basic data set. This comprises some 40 elements of general information such as age, sex, weight etc. The researchers also agreed on additional data modules for certain diagnostic information, for instance, those obtained during ECG readings or echocardiographic examinations. The modules specify exactly which data should be collected during the respective examination. When preparing their respective studies, clinical researchers can use this modular data system to create a so-called case report form (CRF). A CRF can also be supplemented by additional study-specific queries.

The more uniform the data, the greater their value for research purposes. For comprehensive statistical evaluations of data from different studies it is therefore crucial that the data be generated and recorded under the exact same conditions. For this purpose, the DZHK has developed uniform working guidelines referred to as standard operating procedures (SOPs). These are detailed guidelines, for instance on how blood should be taken or how exactly a 6-minute walk test should take place, because such procedures tend to differ slightly from clinic to clinic or from study to study. This harmonisation and standardisation process was and still is a major challenge for DZHK researchers, because in addition to the demands of their own study, they must also bear in mind the demands of other studies and future studies. At present the DZHK has seven SOPs for clinical studies and two for biobanks (see below). 

Use and Access Policy

The real research work begins when the data from the clinic, biobank and imaging studies are pooled and statistically evaluated in relation to the specific research question being investigated. Who will have access to the data, who has ownership of the data and how scientific publications will be produced is regulated in a comprehensive Use and Access Policy agreed by all DZHK partners.

Ethics Concept

Before participating in a clinical study, patients are first required to give their consent. In the DZHK, a standard ethics concept regulates how the data and biological samples can be used, how patients will be informed and what options they have to withdraw their consent.

IT Infrastructure 

Data is collected within the scope of DZHK clinical studies in the participating clinics (decentralised data collection), and stored and archived centrally. For ongoing DZHK studies these data include general patient information as well as data on treatment and diagnosis. In future, data on biological materials and imaging data are also to be collected and stored in this manner.

Central Data Management (ZDM)

The ZDM consists of two elements: an Independent Trusted Third Party (TTP) located at the University of Greifswald and a Data Handling at the Institute for Medical Informatics of the University Medical Centre Göttingen.

All clinical data acquired during a study are transmitted for data storage via a special web-based data input software package (SecuTrial), with which every DZHK clinic is equipped, to the Institute for Medical Informatics in Göttingen where the data are saved and archived. Using the same software, all personally identifiable data are transmitted to the trust agency in Greifswald. There, the data is pseudonymised and only this information will be passed on in future. The pseudonymised data requires data protection because this is the only way to ensure that patients’ personal data cannot be linked to their health data. The trust agency is also responsible for the administration of patients’ declarations of consent.

Biobank and Management of Biomaterial Specimens

 

Biomaterial specimens form the basis for the systematic search for biomarkers of disease. Biobanking operations are therefore an important element of the DZHK research strategy. In all its clinical studies, the DZHK collects not only data on diagnosis and treatment, but also biomaterial such as blood, urine and tissue samples. In the DZHK, biosamples are decentrally stored, which means that each partner site has its own biomaterial storage facility. In order to be able to compare biomaterials from the different partner sites, the procedures for collecting, processing and storing biosamples need to be as uniform as possible. As with the clinical data, this is regulated by SOPs.

Biomaterial specimens are managed via an electronic Laboratory Information Management System (LIMS). In addition, metadata on the biosamples, such as times at which samples were taken, subsequent processing in the laboratory, transport and storage conditions, results of analyses as well as issuance and utilisation information are also recorded using the LIMS. All DZHK partners will be able to access the LIMS system through a web browser; the trust agency will provide the pseudonyms. The trust agency sends the data to the appropriate central server where the data on the biomaterial samples are stored. Where this server will be located has yet to be decided.

Imaging Data and Imaging Data Management

Imaging data provide detailed information on the characteristics of cardiovascular diseases and are therefore an important component of DZHK clinical studies. Imaging techniques have the ability to visualise typical morphological and functional changes, which may also serve as biomarkers. The DZHK has therefore decided to develop a uniform Imaging Data Management System (IDMS). In this case, too, the DZHK intends to establish a system of decentralised image data capture and centralised data storage.

Transfer Office 

When addressing scientific questions, it is particularly interesting to correlate clinical data, biomaterial data and imaging data and to evaluate them jointly. The Transfer Office is where the various data come together and where data are issued according to the criteria defined by the researchers. The Transfer Office IT systems are also located in Göttingen.

 

Speaker of the clinical-scientific infrastructure:
Prof. Dr. med. Matthias Nauck


Contact:
Dr. Julia Hoffmann,
Coordinator Scientific Infrastructure, DZHK Main office
phone: +49 30 3465 529-17, julia.hoffmann(at)dzhk.de

Study Preparation/ Conduct: More information and assistance is provided here.