On a Basis Agreement
The collection of information on clinical patient data, biomaterial data and on clinical trial characteristics is the basis of the CCP.
In order to allow inclusion of already existing data collections at the partner sites, special efforts were taken to establish a governance structure that respects the contribution of scientists at the partner sites involved in the collection of patient data and biomaterials. Therefore the core element of the CCP is based on a network concept. Participating institutions were asked to keep and develop their own collections, to agree upon joint SOPs including database standards, and to install IT interfaces that allow seamless collaboration.
Rules and Regulations
The following rules and regulations were negotiated and agreed upon:
- Participating hospitals/CCCs install an IT infrastructure that allows them to contribute patient and biomaterial data for collaborative research.
- Participating institutions systematically obtain consent from their cancer patients to contribute clinical data and biomaterial for academic collaborations.
- They upload very limited clinical, biomaterial and trial data to a central registry (for a reason, see below).
- Decisions on the provision of clinical data and biomaterial for joint research remains subject to local rules and regulations. Local governance is not overruled by the DKTK.
- Provide a well characterized patient data base with diagnostic biomaterial available for biomarker-driven early clinical trials and translational projects
- Support of innovative early clinical trials
- Communication and networking between
- collaborators at sites (scientists and physicians)
- the different sites
- programs and platforms regarding clinical data, samples and clinical trials and within
- DKTK and beyond.