Management of clinical trials working group
Ensuring the quality of science-driven trials
The working group for the management of clinical trials was set up in 2004 in order to develop joint solutions within the TMF community to the new and complex requirements placed on science-driven clinical trials as a result of the 12th amendment to the German Pharmaceutical Products Act (AMG) and to intensify the exchange between research networks on this issue.
The working group was able to initiate numerous projects, some of which have already been successfully concluded. For example, Standard Operating Procedures (SOPs) and checklists are available and training for communicators on carrying out Investigator Initiated Trials (IITs) in accordance with the 12th amendment to the AMG has not only taken place in several German cities but has also been very well received.
(Letzte Aktualisierung: 23.04.2012)
Spokesperson
Dr. Xina Grählert
Coordinating Centre for Clinical Trials Dresden
Medical Faculty C. G. Carus
Techical University Universität Dresden
Phone: +49 3 51 4 58 51 61
E-Mail
Vice Spokesperson
Carmen Schade-Brittinger
EDNET
Phone: +49 64 21 / 2 86 64 58
E-Mail
Contact person in the TMF Office
Dr. Ulrich Gauger
Phone: +49 30 31 01 19 83
E-Mail