Open on EUR-Lex ↗

Recital 67

Recital 67

(67)An electronic system should be set up at Union level to ensure that every clinical investigation is recorded and reported in a publicly accessible database. To protect the right to the protection of personal data, recognised by Article 8 of the Charter of Fundamental Rights of the European Union (‘the Charter’), no personal data of subjects participating in a clinical investigation should be recorded in the electronic system. To ensure synergies with the area of clinical trials on medicinal products, the electronic system on clinical investigations should be interoperable with the EU database to be set up for clinical trials on medicinal products for human use.

Official text · the act as publishedFrom the act as published (consolidated texts do not carry recitals or the preamble). Open full page ↗
4 queries · page built in 6 msInventory f82bbfa3