CoBi has its local headquarters in Dresden, where both the Clinical Trials Unit research department of DKMS and the sample manager are located.
The work to establish CoBi began in the 3rd quarter of 2015 with the coordinative planning for the scientific and technical design of the Biobank. CoBi has been approved by the Ethics Committee at the Technical University of Dresden, which marked the start of the further involvement of the cooperation partners.
Management of CoBi
The administrative and coordinative management will be taken over by the Clinical Trials Unit (CTU) of the DKMS based in Dresden. Among other things, the unit is responsible for providing technical support for the database and managing the resources within the Biobank. For research groups making requests, the CTU is responsible for the coordination and release of samples and/or data from CoBi. Direct access to the samples and electronic data records is, however, excluded for the DKMS.
As equal cooperative partners of the DKMS, the transplant centres are responsible for the inclusion of patients and related donors. Apart from the input and administration of personal data, the transplant centres are responsible for the collection and the dispatch of samples to the CoBi sample manager. They are obliged to transmit the data records and samples to CoBi in encrypted form only.
The Collection Centres are also integrated within the CoBi as cooperation partners of the DKMS. They are responsible for the inclusion of interested unrelated donors and, in this context, for the collection and dispatch of the samples to CoBi. Collection Centres are also responsible for ensuring that the data records and samples of Donors are only transmitted in coded form to CoBi.
The Scientific Committee monitors the use of samples and/or data from CoBi. Its tasks include the medical and scientific review and evaluation of DKMS research projects that are to be carried out with the resources of the biobank.
The Scientific Advisory Board consists of the members of the Transplant Centres and the DKMS and is supported by two expert groups in the fields of immunogenetics and statistics.
Trusted Third Party and Sample Administrator
Another cooperation partner of CoBi is the Trusted Third Party of the University Medicine in Greifswald. The Trusted Third Party is responsible for the administration of the personal identifying data and is responsible for the creation of a unique pseudonym for each participant of the Biobank. In this way, protection of the data of each participant can be ensured.
The processing and long-term storage of the samples is the responsibility of the contractually bound sample manager. The DKMS Life Science Lab GmbH was selected as the sample administrator based on its experience in handling sensitive data and samples and a mature quality assurance concept. All tasks are coordinated and approved by the CoBi team.
A list of all essential cooperation partners can be found here.