Clinical Research Platform (CRP)
The DZHK Research Platform consists of IT infrastructures, processes, support services, and regulations that provide the framework for all DZHK clinical studies. All DZHK studies are required to use this platform and to make their data available for secondary use (DZHK Heart Bank). The platform enables the standardized collection of clinical data, imaging data, and biosamples, and facilitates their subsequent use for research questions beyond the primary study objectives.
In this way, a valuable repository of cardiovascular data and samples is created, which is accessible to researchers worldwide
The Clinical Research Platform at a Glance
- Standardised Data Collection
Data and biosamples are collected standardised according to Standard Operating Procedures (SOP) by all participating study centres.
- Ethics Concept
A uniform ethics concept in the DZHK regulates what may be done with the data and samples, how patients are informed and what possibilities they have to withdraw their consent.
- Pseudonymisation
The personal identifying data is stored by our Trusted Third Party office in Greifswald under a pseudonym so that no conclusions can be drawn about individuals.
- Central Data Storage
Clinical data are stored centrally in a data base in Göttingen.
- Centralized Biobank
The biosamples from our trials are stored at the Biobank Greifswald. Data are stored in Greifswald, too.
- Image Data Management System
Image data from cardiac examinations are stored centrally and with automatic quality checks in the TrialComplete data management system.
- Data and Sample Collection
The standardised aquisition of data from all DZHK studies results in a collection that is available to scientists worldwide for future research.
- Transfer Office
The transfer office brings together clinical data as well as biosamples and image data and makes them available to scientists.
- Use and Access Policy
The policy governs the transfer of data to interested scientists. It is the responsibility of the Use & Access Committee.
- Data Protection
A harmonized data protection concept according to the highest standards ensures the security of all data.
DZHK basis dataset
The DZHK basis dataset constitutes the common, standardized foundation of all clinical DZHK studies. It is collected in an identical format (in accordance with SOPs) for every enrolled participant, regardless of the specific study protocol. Its objective is to provide a comparable, high-quality, and harmonized data basis that enables cross-study and cross-site research, cohort comparisons, and the linkage with imaging data as well as biospecimens. The DZHK basis dataset, which is mandatory for DZHK studies, includes demographic information, medical history, diagnoses, clinical parameters, and laboratory values. For each study, the DZHK basis dataset can be supplemented with study-specific items or modules.
Included items
Demographics & examination time points
- Date of examination
- Enrollment date
- Date of birth
- Age at enrollment
- Sex
- Ethnic background (e.g., Caucasian)
Family and personal risk factors
- Family history of myocardial infarction or stroke
- Diabetes mellitus
- Arterial hypertension
- Dyslipidaemia
- Smoking status
- Current need for dialysis
Cardiovascualr disease
- Coronary heart disease
- Condition following myocardial infarction
- Cardiomyopathy
- Heart failure
- Atrial fibrillation
- Medically diagnosed heart valve disease
- Congenital heart defect
Interventions & implantats
- Interventional coronary revascularisation
- Coronary bypass surgery
- Heart valve surgery
- Implanted pacemaker or defibrillator
Other diseases
- PAOD
- Stroke/TIA
- Chronic lung disease
- Depression
- Cancer/tumour
- Neurological diseases*
- Mental illnesses*
