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Competent Authorities have published detailed Guidelines on clinical trials:
- 3. Bekanntmachung zur klinischen Prüfung von Arzneimitteln am Menschen (see the unofficial English translation: 3rd Announcement on clinical trials of medicinal products for human use): deals with general conditions of a clinical trial and
- Bekanntmachung zu nicht-kommerziellen klinischen Prüfungen (Notification on non-commercial clinical trials): deals with the conditions of investigator initiated trials.
