Clinical Investigations - A German View
CA Notification Requirements:
- Notification required for all clinical investigations
- 60 day waiting period obligatory if EC option has not been obtained however, if EC option obtained notify and start
- Notification electronic via www.dimdi.de website requires registration
- No fees
- Standard notificatiopn form on website, only available in German
- Language: German
- Competent Authorities set up under each German Authority list can be found at www.bfarm.de. Notify CA where co-ordinating clinical investigator is for multi centre sites
Ethics Committee Information
- Submit to Ethics Committee at each hospital
- Documentation to submit includes, CIP & summary, consent docs in German, CE certificate for CE marked products, CRFs, IFU, insurance policy
- Cost varies between committees
- Private ECs registered under German law can perform review, list of registered ECs can be found at www.bfarm.de
- Many institutions also require review by their own committees in addition to a private EC review
Comments/Practical Experience
- Device labelling in German
- Insurance required to be taken out by company conducting business in Germany minimum €500,000 per subject
- Hospital may charge for the CI
Further information will be available within the 'Medvance Country Specifications' booklet which will be available shortly via the Medvance website. Further information will be announced in a future newsletter.
