Centrum für Chronische Immundefizienz - CCI

Links

Clinical Trials Unit at the Medical Center - University of Freiburg
The Clinical Trials Unit at the Medical Center - University of Freiburg provides comprehensive professional services for the planning, conducting and analysis of clinical trials.
http://www.studienzentrum.uniklinik-freiburg.de

Institute of Medical Biometry and Statistics (IMBI) at the Medical Center - University of Freiburg
One area of focus at the IMBI is methodical and applied biomedical research as well as statistical consultation. The IMBI and the CCI Clinical Trials Office work closely together in these areas.
http://www.imbi.uni-freiburg.de

German Clinical Trials Register (DRKS)
The German Clinical Trials Register is an open access online register on both current and completed clinical trials conducted in Germany. You need an account to register your own trials where you can make your data accessible to others. The DRKS has been an approved Primary Register in the WHO network since October 2008.
http://www.drks.de

Clinical trials.gov (National Institutes of Health, U.S.A.)
Here clinical trials are listed independently of the category. The database can be searched for trials using different criteria, e.g. by disease or trial location. It also contains general information on clinical trials so it is useful for patients and their families as well as health care professionals.
http://clinicaltrials.gov/

Telematic platform for Medical Research Networks (TMF)
This is an umbrella organisation for medical research networks who are members of the TMF and who are funded by Health Research Programmes of the BMBF (Federal Ministry of Education and Research). Most of the information is available in German only.
http://www.tmf-ev.de/

Paul-Ehrlich Institute (PEI)
The Paul-Ehrlich Institute (PEI) is the national German institution responsible for the authorization of specific biological medicinal products such as serum, blood preparations and vaccines in Germany for their use in human and veterinary medicine. Here you will find information on the PEI itself as well as on national legislation regarding these medical products.
http://www.pei.de/

European Medicines Agency (EMA)
The EMA is responsible for the scientific evaluation of medicines developed in the EU with the aim of protecting human and animal health. It functions as a centralized agency for all EU countries to provide an optimal authorization and vigilance of medicinal products in Europe. It cooperates with international agencies. Here you will find more information on the Agency and the Committee for Medicinal Products for Human Use (CHMP) recommendations.
http://www.ema.europa.eu/

World Medical Association (WMA) - Helsinki Deklaration
Here you can find one of the most important international ethical regulations of biomedical research, the Declaration of Helsinki in English, French and Spanish.
http://www.wma.net/e/

Federal Institute for Drugs and Medical Devices (BfArM)
This is an independent federal authority within the Ministry of Health in Bonn. The BfArM is responsible for the authorization and batch analysis of medicinal products and medical devices. Here you will find information on this institution and the licensing procedures for medicinal products and medical devices. Forms for the communication of undesirable side effects of drugs are available here.
http://www.bfarm.de/

Medical Ethics Committees in Germany
Here you will find information on Ethics Committees in Germany.
http://www.ak-med-ethik-komm.de/

Ethics Committee
Website of the Ethics Committee of the Albert-Ludwigs-University, Freiburg. Includes application forms.
http://www.uniklinik-freiburg.de/ethikkommission/live/index.html

ICH-GCP Guidelines
Here you will find the current Good Clinical Practice consolidated Guidelines of the International Conference on Harmonisation (ICH-GCP)
http://ichgcp.net/de/