
This article describes the experiences of the Medical University of Vienna with the Directive 2001/20/EC (CTD) regarding academic clinical research and reflects on the changes introduced by the Regulation (EU) 536/2014 (CTR).

This article describes the experiences of the Medical University of Vienna with the Directive 2001/20/EC (CTD) regarding academic clinical research and reflects on the changes introduced by the Regulation (EU) 536/2014 (CTR).

The language in Europe's Regulation (EU) 536/2014 regarding ethical review of protocols is concerning.

Published: April 1st 2017 | Updated:

Published: May 1st 2017 | Updated: