CTO: For IITs. At DKFZ. We stand for quality, networking and transparency
Mission:
Our mission is to enable excellent Investigator Initiated Trials (IITs) that create a direct benefit for people through innovative research and practice-oriented solutions. We rely on clear and transparent communication, the establishment of efficient structures and comprehensive support services. With a strong focus on quality and competence, we apply controlled processes to ensure that regulatory requirements are consistently met. Our advice and support are always geared towards current standards and the needs of science and administration. At DKFZ, we ensure the success and integrity of the entire study through responsible sponsor oversight and create trust in every phase of the research process. We also support the optimization of the trials in the NCT IIT portfolio.
Tasks:
The Clinical Trials working group supports the organization and coordination of clinical trials at both the DKFZ and the NCT and ensures their regulatory and organizational feasibility.
At the DKFZ, we offer comprehensive advice for study projects, particularly with regard to regulatory, organizational and financial aspects. In addition, we coordinate the DKFZ sponsor process and work closely with the study team and DKFZ administration to ensure the efficient administrative implementation of trials. In the area of Sponsor Oversight, we monitor the compliant implementation of clinical trials under the formal sponsorship of DKFZ and support the principal investigators by providing regular support throughout the course of the study. We coordinate communication between all parties involved and the study team in order to resolve challenges quickly together. In addition, we provide overarching structures and processes for clinical research such as data collection systems and a centralized archiving solution to ensure that study data is managed efficiently. Furthermore, we act as a central interface to authorities and external partners.
At the NCT, the department supports the feasibility of NCT Investigator Initiated Trials (IITs) by providing recommendations on regulatory, organizational and timing aspects. We coordinate the NCT Trial Monitoring Board (TMB), which assesses the medical feasibility of the trials and supports the trial teams with cross-site medical expertise. In addition, we offer comprehensive budget consultation to optimize the planning of study budgets and integrate them into detailed milestone planning. Another central area of responsibility at the NCT is monitoring the efficient implementation of IITs. We interface the Clinical Trial Centers (CTCs) and ensure the harmonization of quality requirements as well as continuous communication between all parties involved. In close cooperation with the experts at the various sites, we develop central solutions for harmonized processes and digital tools in order to continuously increase the efficiency and quality of study processes at the NCT.
In summary, the department makes a decisive contribution to the success of clinical trials at both the DKFZ and the NCT by providing advice, coordination, monitoring and the provision of infrastructure and processes.