Clinical Activities

The project group Clinical Activities provides support for clinical activities conducted by DKFZ investigators and provides coordination and administrative support for the Committee of Clinical Activities at DKFZ.
The Committee of Clinical Activities at DKFZ was founded 1999 to assure the transparency and regulatory compliance of all clinical trials performed by DKFZ investigators. The Committee of Clinical Activities at DKFZ maintains a multidisciplinary membership selected from the scientific, clinical and biostatistical staff at DKFZ to ensure adequate review of diverse clinical research activities.
The conduct of clinical trials is governed by national and international legislation, guidelines and standards. The European Union's so called Clinical Trials Directive 2001/20/EC was implemented in national law in Germany in August 2004, leading to the 12th amendment of the German Drug Law (Arzneimittelgesetz). The directive is intended to harmonize the clinical trials’ regulatory environment across the European Union and to improve protection of human subjects. It lays down the principles and guidelines of Good Clinical Practice (GCP). As the regulation applies to all clinical trials on medicinal products for human use, and as only non-interventional studies are excluded, academic, investigator-initiated clinical trials will also have to comply with the EU clinical trials directive implemented in the German Drug Law.

The primary aim of the project group Clinical Activities is to integrate and facilitate the management, coordination and conduct of clinical research at DKFZ and to ensure that clinical research processes meet local, state, federal policies and regulations.

The following objectives are designed to accomplish this aim:

• Implementation of a DKFZ internal electronic study register
• Advice of scientists and medical scientists
• Providing education to support researchers to comply with regulatory requirements
• Implementation of a quality management system
• Implementation of structures to observe the Law concerning medical devices (Medizinproduktegesetz / MPG ) and the Ordinance concerning the setting up, operation and application of medical devices (Verordnung über das Errichten, Betreiben und Anwenden von Medizinprodukten).

Contact

• Dr. Silke Müller