LFU:online

including EUDRACT registration, Clinical Trial Application (CTA) and maintenance (i.e. Substantial Amendments) Ethics Committees Operations, CRO, Site Handling, Oversight and Good Investigator Practice

·         Clinical Trial Application: documents (study protocol, informed consent form, CRFs, Investigator’s Brochure, processes (CTIS), cooperation ECs & CA

·         Study start-up: necessary (additional regulatory & organizational) steps

·         Life-cycle Management of clinical trials: amendments, notifications, reports

·         Clinical conduct: patient recruitment (incl. consent process), documentation

·         Monitoring

          ·         Pharmacovigilance in clinical trials

Seminar mit Anwendung des Erlernten auf spezifische Fragestellungen durch die Studierenden.

Modules 1 and 2