KKS Magdeburg - Internal Cooperation

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) Tel.: 0391-67-14344 norbert.beck@med.ovgu.de
	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 Cover letter requesting consultation of the study according to MBOÄ § 15 Form Consultation Overview EK → Beratungsformular Study protocol incl. contact details Informed consent incl. data protection Any questionnaires or other documents relevant to your studies
Unit for Research (REFO) and Third-Party Funding Management
	Dipl.-Kff. Melanie Thurow Tel.: 0391-67-25130 melanie.thuro@med.ovgu.de The acquisition of public third-party funds, Research availability areas and other research resources, Contractual arrangements for research collaborations and material/data transfer, Announcements of junior researcher awards and scholarships, The registration of patents and utility models in cooperation with the TUGZ. Administration and control of research-related third-party funds incl. preparation of numerical proofs Processing of contracts in the context of contract research Calculation of costs of contract research Preparation of statistics and reports
Institute of Biometry and Medical Informatics (IBMI) → Consultation Request Form
	Director: Prof. Dr. rer. nat. Dr. med. Johannes Bernarding (Manager) Tel.: 0391-67-13535, -15537 johannes.bernarding@med.ovgu.de Deputy Director: Dr. rer. nat. Markus Plaumann Tel.: 0391-67-13508, -17859 markus.plaumann@med.ovgu.de Creation e-CRF: Dipl.-Ing. Sebastian Baecke Tel.: 0391-67-13546 sebastian.baecke@med.ovgu.de Statistic Consultaton / Biometry: Dipl.-Math. Anke Lux Tel.: 0391-67-13530 anke.lux@med.ovgu.de
Stabsstelle Recht
	Attorney Ute Klanten (Manager/Data Protection Officer) Tel.: 0391-67-15753 ute.klanten@med.ovgu.de Data Protection Management: Susan Rönnebeck Tel.: 0391-67-15192 susan.roennebeck@med.ovgu.de For Insurance: Christina Knappe christina.knappe@med.ovgu Tel.: 0391-67-15082
Central Pharmacy (ZAP)
	Dr. rer. nat. Stefanie Zibolka (Manager) Tel.: 0391-67-15941 stefanie.zibolka@med.ovgu.de Dr. rer. nat. Denise Kramer Tel.: 0391-67-13543 denise.kramer@med.ovgu.de
Institute for Clinical Chemistry and Pathobiochemistry IKCP) → Formblatt
	OÄ Dr. med. Katrin Borucki (Deputy Director) Tel.: 0391-67-13928 katrin.borucki@med.ovgu.de Mandy Schulze Tel.: 0391-67-13901 mandy.schulze@med.ovgu.de
Radiation Protection Unit
	M.Sc. Nicole Fröhlich (Radiation Safety Officer) Tel.: 0391-67-25177 nicole.froehlich@med.ovgu.de
Board of Management Area 2 - Information Security (V2)
	Dr.-Ing. Jana Fruth (Manager) Information Security Officer (ISB) Tel.: 0391-67-25142 jana.fruth@med.ovgu.de Dipl.-Ing. André Helm (Deputy Information Security Officer) Tel.: 0391-67-25162 andrè.helm@med.ovgu.de
Business Unit IT and Medicine Technic
	Dr. Robert Waschipky (Manager) Tel.: 0391-67-15710 robert.waschipky@med.ovgu.de
Medicine Technic Department(G6.1)
	M.Sc. Sabine Deux Tel.: 0391-67-15700 sabine.deux@med.ovgu.de
Purchasing Business Unit(G3)
	Dipl.-Ing. Christian Zander (Manager) Tel.: 0391-67-15152 christian.zander@med.ovgu.de
Central German Competence Network Rare Diseases
	Prof. Dr. med. Klaus Mohnike Tel.: 0391-67-24016 klaus.mohnike@med.ovgu.de Dr. med. Katja Palm Tel.: 0391-67-24000 katja.palm@med.ovgu.de Susann Empting Tel.: 0391-67-24031 susann.empting@med.ovgu.de 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.

MEDIZINISCHE FAKULTÄT

UNIVERSITÄTSKLINIKUM MAGDEBURG A. ö. R.

COORDINATION CENTER FOR CLINICAL STUDIES

Internal Cooperation