Recital 161
General Data Protection Regulation · UE 2016/679
| (161) | For the purpose of consenting to the participation in scientific research activities in clinical trials, the relevant provisions of Regulation (EU) No 536/2014 of the European Parliament and of the Council (15) should apply. |
In Luxembourg, the law of 1 August 2018 on the CNPD and the general data protection regime together with the law of 24 July 2014 on patient rights govern biomedical research, with prior authorisation from the CNER (National Research Ethics Committee) and notification to the Ministry of Health. The IBBL (Integrated BioBank of Luxembourg) and the LIH (Luxembourg Institute of Health) are structuring actors to involve from protocol design.
Luxgap practice: we prepare CNER files with the dual CTR 536/2014 and GDPR articulation using the Luxembourg submission format, and coordinate with the CHL or LIH DPO for multicentre trials.
