ECAmendment object

Any substantial amendments to the study protocol
(that are likely to affect the safety of participant or change the interpretation of the scientific documents)

Sponsor

35
From date of receipt of valid application

Yes

Art 45 a) OMS 904/2006 – Normelor referitoare la implementarea regulilor de bună practică în desfăşurarea studiilor clinice efectuate cu medicamente de uz uman
(Order 904/25 Jul 2006 on approval of rules relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use)