Receipt of received safety report from Danish Medicines Agency and Health Research Ethics #4d, Approval of 1. amendment Danish Dataprotection Agency (danish) #4c (print document(s) and place in your Site Master File)
The Danish Medicine Agency (in Danish, the top three documents are new) #4.a, Videnskabsetisk komité (in Danish, the top two documents are new) #4.c. (print document(s) and place in your Site Master File)
Date: 2018.08.30 at 12.00 am
Approval of amendments from ethic committee has mistakenly been misplaced as amendments for the protocol – There are no amendments for the protocol #1.b., and the amendments – The committees on health research ethics and Den videnskabsetiske komité (in Danish) are moved to their right environment # 4.c. – apologize for the inconvenience.
AID-ICU trial documents are now accessible at the homepage. Access to “Documents for National investigator” will still require a password to get access (you may e-mail to contact@cric.nu to get password) (print document(s) and place in your Site Master File)