Providing education to support researchers to comply with regulatory requirements

To achieve a sensitization for regulatory requirements following educational talks and seminars were arranged and intranet pages were created:

Seminars

- "From Bench to Bedside – the regulatory point of view of in-vitro-diagnostic": 30.10.2007, J. Stockhardt, consulting & more, Bensheim
- "Regulatory requirements of conducting clinical studies" (dkfz Informationsveranstaltung “Patienentenstudien und Körpermaterialstudien – Information zur Durchführung und Rechtslage“), 19. May 2006, C. von Kalle, K. Potthoff, A. Eisenmenger
- "IITs – regulatory requirements and suggestions of practical implementation" (dkfz Informationsveranstaltung "Klinisch wissenschaftliche Studien – Rechtliche Vorgaben und praktische Umsetzung"), 01. June 2005, P. Huber, A. Eisenmenger, T. Strowitzki, S. Luntz, R. Herzog.

Education

- "The DKFZ Study Register and conducting studies with human body material" ("Registrierung klinischer Studien und Durchführung von Körpermaterialstudien amDKFZ"), 18.04.2007, S. Müller.
- "The DKFZ Study Register" ("Registrierung klinischer Studien am DKFZ"), 30.03.2007, S. Müller
- "Act of medical devices-3rd amendment" (3. MPG Änderung – Entwurf), 06.03.2007, S. Müller
- "In-vitro-Diagnostica", 2007, S. Müller
- "GCP-Inspections, necessary infrastructure for DKFZ", 2007, S. Müller
- "Principal investigator Course" in cooperation with the Coordinating Centre for Clinical Trials in Heidelberg, the Project group Clinical Activities hosted a clinical investigation course for clinical researchers. During 2 days, participants were systematically instructed by 10 lecturers on clinical trials (planning, treatment by protocol, data management, biometrics, ethics, and law), 13./14.05.2006
- "Good Clinical Practice"”, 4.11.2005, A. Eisenmenger

Implementation of an intranet website

- to inform on registration of clinical studies and clinical activities at the DKFZ
- to provide access to the internal electronic study register
- to inform on tasks and members of the Committee of Clinical Activities at DKFZ
- to inform on the tasks of the project group Clinical Activities
- to give an overview on seminars held
- to provide links to websites containing relevant regulatory documents
- to give access to the SOPs of the Research Program “Imaging and Radiooncology” for all employees of the Research Program