Internal Cooperation
Due to European directives as well as national laws and resulting national guidelines, the KKS Magdeburg as the quality assurance unit of the sponsor is obliged to monitor the conduct of non-commercial clinical trials (IITs) at all times.
Therefore, KKS Magdeburg works closely with the following institutions:
| Lead Ethics Committee of the University of Magdeburg |
|
|
Dr. Norbert Beck (Managing Director) |
|
|
Clinical trials with medicinal products according to EU Regulation 536/2014 (CTR) and AMG The documents are no longer sent separately to the Ethics Committee. The complete submission process is carried out electronically via the EMA's Clinical Trial Information System (CTIS) by the sponsor of the clinical trial. The responsible ethics committee is assigned via a defined business allocation plan of all participating ethics committees in Germany. Clinical trials with medical devices according to EU Regulation 745/2017 (MDR) and MPDG The documents are no longer sent separately to the Ethics Committee. The complete submission process is carried out electronically by the sponsor of the clinical trial via the German Medical Devices Information and Database System (DMIDS) of the BfArM. Currently, the ethics committee of the principal investigator is still responsible for this.. Other Clinical Studies 1 x paper version, 1 x digital on USB, email or via DocShare
|
|
| Unit for Research (REFO) and Third-Party Funding Management |
|
|
Dipl.-Kff. Melanie Thurow
|
|
| Institute of Biometry and Medical Informatics (IBMI) → Consultation Request Form |
|
|
Director: Deputy Director: Creation e-CRF: Statistic Consultaton / Biometry: |
|
| Stabsstelle Recht | |
|
Attorney Ute Klanten (Manager/Data Protection Officer) Data Protection Management: For Insurance: Tel.: 0391-67-15082 |
|
| Central Pharmacy (ZAP) | |
|
Dr. rer. nat. Stefanie Zibolka (Manager) Dr. rer. nat. Denise Kramer |
|
| Institute for Clinical Chemistry and Pathobiochemistry IKCP) → Formblatt | |
|
OÄ Dr. med. Katrin Borucki (Deputy Director) Mandy Schulze |
|
|
M.Sc. Nicole Fröhlich (Radiation Safety Officer) |
|
|
Dr.-Ing. Jana Fruth (Manager) Information Security Officer (ISB) Dipl.-Ing. André Helm (Deputy Information Security Officer) Tel.: 0391-67-25162 |
|
| Business Unit IT and Medicine Technic | |
|
Dr. Robert Waschipky (Manager) |
|
| Medicine Technic Department(G6.1) | |
|
M.Sc. Sabine Deux |
|
| Purchasing Business Unit(G3) | |
|
Dipl.-Ing. Christian Zander (Manager) |
|
| Central German Competence Network Rare Diseases |
|
|
Prof. Dr. med. Klaus Mohnike Dr. med. Katja Palm Susann Empting The Central German Competence Network for Rare Diseases (MKSE) is a central institution of the Medical Faculty of Otto von Guericke University and as such directly assigned to the Dean. The management has been assigned to Prof. Dr. Klaus Mohnike. |
|
