Information about requirement of submission of Clinical Study Reports

Current information for sponsors, contact persons, CRO, about the requirement to submit the Clinical Study Report to State Institute for Drug Control (hereinafter „Institute“).  

Following the ïnformation given on seminar (May 2013) for sponsors, contact persons or CROs we inform you about the requirement to submit the Clinical Study Report to Institute in electronic version (CD or DVD ROM or via secured e-mail (Eudralink).

 

Clinical Trial Unit
dated July 18, 2013