Skip to content
Log for new documents and/or new versions updated:
Print version – please notice the “download” feature is situated underneath the pdf.
Date: 2018.06.19 at 12.20 am
Annual Safety Report 2018, #Fane 4.f, (print and place in your Site Master File)
Date: 2018.02.28 at 5.45 pm
Trial completion (in Danish) #Fane 16, Table of content, and News letter , #Fane 13.f, 22’nd News letter (print and place in your Site Master File)
Date: 2018.01.24 at 4.30 pm
Anmeldelse og sikkerhedsdokument (in Danish) #Fane 4.d, (print and place in your Site Master File)
Date: 2018.01.11 at 2.50 pm
EudraCT #Fane 4.b, Sikkerhedsdokument (in Danish) #Fane 4.d, (print and place in your Site Master File)
Date: 2017.11.24 at 8.30 am
News letter , #Fane 13.f, 21’st News letter (print and place in your Site Master File)
Date: 2017.11.23 at 1.00 pm
Drug Disposal Form, #Fane 10.c (print and place in your Site Master File)
Date: 2017.10.30 at 1.00 pm
News letter , #Fane 13.f, 20’th News letter (print and place in your Site Master File)
Date: 2017.09.22 at 3.30 pm
News letter , #Fane 13.f, 19’th News letter (print and place in your Site Master File)
Date: 2017.08.24 at 3.00 pm
News letter , #Fane 13.f, 18’th News letter (print and place in your Site Master File)
Date: 2017.08.24 at 1.30 pm
Amendment to protocol Appendix 3 #Fane 1.b, amendment to Danish Medicine Agency approval (in Danish) #Fane 4.a, amendment to Ethic Committee approval (in Danish)#Fane 4.c, Table of content (print and place in your Site Master File)
Date: 2017.07.17 at 3.00 pm
News letter , #Fane 13.f, 17’th News letter (print and place in your Site Master File)
Date: 2017.06.14 at 4.50 pm
News letter , #Fane 13.f, 16’th News letter, Annual Safety Report, #Fane 4.f (print and place in your Site Master File)
Date: 2017.06.06 at 12.00 am
Drug transfer form, #Fane 10.f is updated and Drug transfer procedure is added to #10.f, and as a consequence Table of content has changed (print and place in your Site Master File)
Date: 2017.05.19 at 3.30 pm
News letter , #Fane 13.f, 15’th News letter, Drug transfer form, #Fane 10.f is added and as a consequence Table of content has changed (print and place in your Site Master File)
Date: 2017.04.11 at 11.50 am
News letter , #Fane 13.f, 14’th News letter (print and place in your Site Master File)
Date: 2017.03.20 at 3.40 pm
Date: 2017.03.10 at 4.00 pm
REMINDER: Annual Safety report , #Fane 4 (print and place in your Site Master File)
Date: 2017.03.10 at 3.00 pm
News letter , #Fane 13.f, 13’th News letter (print and place in your Site Master File)
Date: 2017.02.10 at 11.00 am
News letter , #Fane 13.f, 12’th News letter (print and place in your Site Master File)
Date: 2017.01.10 at 10.30 am
News letter , #Fane 13.f, 11’th News letter (print and place in your Site Master File)
Date: 2017.01.05 at 8.30 am
For Danish sites only:
Nyt Appendix 7 (7.2), #Fane 1.b
(print and place in your Site Master File)
Date: 2016.12.06 at 11.10 am
News letter , #Fane 13.f, tenth News letter (print and place in your Site Master File)
Date: 2016.11.09 at 3.15 pm
News letter , #Fane 13.f, ninth News letter (print and place in your Site Master File)
Date: 2016.10.10 at 11.15 am
News letter , #Fane 13.f, eight News letter (print and place in your Site Master File)
Date: 2016.09.29 at 3.15 pm
Date: 2016.09.23 at 12.45 am
Lommekort, #Fane 9.b.iv, and Folder for Læger, Plejepersonale, #Fane 9.b.v (Danish sites only), Leaflet for Clinicians, Nurses #Fane 9.b.v (print and place in Site Master File)
Date: 2016.09.14 at 1.15 pm
Appendix 7, #Fane 1.b (amendment)
Date: 2016.09.12 at 12.30 am
News letter , #Fane 13.f, eight News letter (print and place in your Site Master File)
Date: 2016.08.30 at 2.30 pm
Contact list, #Fane 15.a, Contact list for GCP-units in DK (Danish sites only, print and place in Site Master File)
Date: 2016.08.17 at 12.00 am
News letter , #Fane 13.f, seventh News letter (print and place in your Site Master File)
Date: 2016.08.09 at 10.40 am
Annual Safety Report, #Fane 4.f (new), Table of Content updated, # at top of Site Master File (print and place in your Site Master File)
Date: 2016.07.11 at 11.15 am
News letter , #Fane 13.f, sixth News letter (print and place in your Site Master File)
Date: 2016.06.20 at 3.10 pm
News letter , #Fane 13.f, fifth News letter (print and place in your Site Master File)
Date: 2016.05.10 at 2.40 pm
News letter , #Fane 13.f, fourth News letter (print and place in your Site Master File)
Date: 2016.04.15 at 1.40 pm
News letter , #Fane 13.f, third News letter (print and place in your Site Master File)
Date: 2016.03.08 at 10.45 am
Trial medication to notice board (English), website address corrected, #Fane 9.b (print and place in your Site Master File) New version
Date: 2016.03.07 at 1.45 pm
Danish Data Protection Agency , update, #Fane 4.d (in Danish only, print and place in your Site Master File) New version
Date: 2016.03.03 at 3.40 pm
News letter , #Fane 13.f, second News letter (print and place in your Site Master File)
Date: 2016.02.09 at 8.40
News letter , #Fane 13.f, first News letter (print and place in your Site Master File)
Date: 2016.01.19 at 11.30 am to 12.30 pm
Please notice, in the files below you need to replace the contact information at the end of the document with the contact information at your location (local site).
-
Information for Participant (#Fane 7.a. in Danish) has been changed from pdf- to word-format.
1. Deltager-information forsøgsværgen New version
2. Deltager-information pårørende New version
3. Deltager-information patienten New version
Date: 2016.01.07
-
-
SUP-ICU medication dispensing system in Danish (#Fane 9.b.i) New version
-
Educational materials (#Fane 9.c.iii) New version
-
Educational materials (#Fane 9.c.vii) in English New
-
Educational materials (#Fane 9.c.vii) in Danish New version
