For broad coordinated access to patient-related lung research data for scientific purposes, study data is stored centrally in the DZL Data Warehouse (DZL DWH) and is kept confidential (pseudonymous). The basis for this is always a corresponding patient consent, which can be revoked at any time. With the DZL Broad Consent, patient data can be acquired based on a DZL wide harmonized legal and organizational standard.
The Rules of Procedure for Sample and Data Processing (GOPDV) in the DZL regulates the handling of clinical and patient-derived research data within the DZL. DZL members, their cooperation partners and external researchers can use the data contained according to a regulated procedure. The ownership of the data remains with the local data-collecting agencies and biobanks as well as (image) databases.
The use of (image) data and biomaterials from the DZL DWH must be requested upon written application. Basic requirements for the approval of an application are a defined scientific project sketch and the valid vote of the local ethics committee. The steering committee decides on the approval and procedure in a multi-stage process (see GOPDV § 3 (3) and Appendix 1). The DZL Ethics Panel provides ethical advice on the use of (image) data and samples.
Queries about existence and number of records in the DZL DWH can be made using interactive filters in the open source software "i2b2" which has been developed at the US universities Harvard and MIT. The software can be reached via https://data.dzl.de/webclient/. All PIs of the DZL already have an i2b2 access. Temporary access can be given upon request to the Central Data Management. All hardware and software components as well as data are operated within Germany. The following video provides a brief introduction to the utilization of the i2b2 query tool.
Combining the data from different lung centers requires a common ontology that contains the essential information such as phenotypes, measured data and sample data in structured form. This includes various annotations such as clear definitions and references to corresponding elements of other classifications such as LOINC or SNOMED-CT. DZL Data Management develops these with the help of the expertise of all sites. The Metadata Management is implemented in the Collaborative Metadata Repository (CoMetaR) as platform for creating, editing, and visualizing a common ontology. The conceptual structure, including annotations, specialized in pulmonary diseases can be viewed and searched at any time at https://data.dzl.de/cometar/web/. In addition, a function is planned that allows a targeted discussion of individual sections of the ontology. Trained personnel, such as medical documentaries, can also participate in the editing process. If you are interested, please contact the DZL Central Data Management.
In order to ensure functionality and security, the software used is subject to regular updates. Access to the data warehouse is reserved for (associate) employees of the DZL. If you would like access data for yourself or one of your employees, please let us know by e-mail.