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Accelerating Clinical Trials in the EU
Support mechanisms for non-commercial clinical trials Level
NationalEU Level (Multinational)Global
Dedicated webpage

Nicht-kommerzielle Klinische Prüfungen - Paul-Ehrlich-Institut (pei.de)

BfArM - FAQ - FAQ CTIS

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Training coursesDialogue BfArM - Training courses and events X 
Scientific advice  XX
Helpdesk, regulatory, CTIS and ethics support

CTIS: Contact via email for general questions on submissions of clinical trial applications: ctatpei [dot] de (ct[at]pei[dot]de) or CTRatbfram [dot] de (CTR[at]bfram[dot]de)

Regulatory and ethics requirements: Dedicated legislation - Clinical Trial Assessment Procedure Ordinance (KPBV) and regular meetings.

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Other services by National Competent Authority
  • Pre-scientific advice;
  • Fee reduction possible;
  • Kick off meetings (scientific advice) e.g. support protocol writing and methodological design.
   
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 supportSee above.   
Funding coordination and navigation of research infrastructureSee above.   
Support identifying research networks    
Other support mechanisms