CAEndOfTrial object
End of trial declaration mandatory for
All clinical trials requiring authorisation by CA
Responsible for End of trial declaration
Sponsor
Regular Termination - Declaration timespan (max nr days)
90
Early/premature Termination - Declaration timespan (max nr days)
15
Reasons for early termination shall be clearly stated
Yes
National legal framework in place
Yes
Applicable national legal framework/ Reference
Art 45 c) 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)
