Support mechanisms for non-commercial clinical trials | Level | |||||||
National | EU Level (Multinational) | Global | ||||||
Dedicated webpage | Nicht-kommerzielle Klinische Prüfungen - Paul-Ehrlich-Institut (pei.de) | X | X | |||||
Training courses | Dialogue BfArM - Training courses and events | X | ||||||
Scientific advice |
| X | X | |||||
Helpdesk, regulatory, CTIS and ethics support | CTIS: Contact via email for general questions on submissions of clinical trial applications: ctpei [dot] de (ct[at]pei[dot]de) or CTRbfram [dot] de (CTR[at]bfram[dot]de) Regulatory and ethics requirements: Dedicated legislation - Clinical Trial Assessment Procedure Ordinance (KPBV) and regular meetings. | X | X | |||||
Other services by National Competent Authority |
| |||||||
Services by ethics committee | ||||||||
Public GCP support | ||||||||
Public research office | Funding is within the remit of the German Ministry of Education and Research. Funding by the Federal Ministry of Health and DLR Projektträger. | |||||||
National funding and other financial support | See above. | |||||||
Funding coordination and navigation of research infrastructure | See above. | |||||||
Support identifying research networks | ||||||||
Other support mechanisms |