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Studies according to AMG/CTR
Within the meaning of Article 2 (2) (2) of Regulation (EU) No 536/2014, a clinical trial is
“…a clinical study which fulfils any of the following conditions:
(a) the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice of the Member State concerned;
(b) the decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study; or
(c) diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects."
Please also comply with our remarks regarding the subject of Data Protection (GDPR).
Your contacts
Head of AMG Studies
Process Managers
AMG Studies, EKHD local EC
- Studies
- Overview DFG-Projects
- Legal matters
- Data Protection
- Quality Management
- CTIS Management
- IT and Information Security
- Fees
- Meeting dates
- About us
- Contact