CLASSIC Log for new documents and/or new versions updated:
Print version – please notice the “download” feature is situated underneath the pdf.
Date 05.01.2023 at 11.28 Updated Trial Completion
Date 27.08.21 at 10.56 Updated co-enrolment list.
Date 19.08.21 at 10.56 Updated co-enrolment list.
Date 16.07.21 at 10.27 Updated newsletter
Date 15.07.21 at 10.59 Updated co-enrolment list.
Date 14.06.21 at 10.59 Updated co-enrolment list.
Date 25.01.21 at 16.25 uploaded EudraCT and EurdraCT xml
Date 13.01.21 at 16.45 pm added ethics committee approved amendment and updated co-enrolment list
Date 27.11.20 at 07.25 Added newsletters
Date 29.06.20 at 11.27
Added approved amendments from Ethics Committe to site master file #4c
Date 01.05.2020 at 10.06 am
Added eCRF Consent form to site master file #2
Date 06.12.2019 at 10.00 am
Updated EudraCT (pdf) and XML versions (for national investigators)
Date 28.11.2019 at 11.52 am
Date 22.11.2019 at 10.37pm
Date 11.11.2019 at 12.46pm
Date 25.09.2019 at 10.24am
Date 29.08.2019 at 18:47 pm
Protocol version 2.3 updated in Site Master File #1 (Print and place in your Site Master File)
Medicines agency approval and Ethics committee approval updated in Site Master File #4 (Print and place in your Site Master File)
Adverse event reporting form updated in Site Master File #14 (Print and place in your Site Master File)
Date 2019.07.23 at 9.58pm
Primary data source (English) updated in Site Master File #12 (Print and place in your Site Master File)
Co-enrolment list updated in Site Master File #8
Contact details updated in Site Master File # 13 (Print and place in your Site Master File)
Date 2019.06.06 at 3.24pm
Date 2019.06.06 at 9.45am
Date 2019.31.05.2019 at 11.50am
Annual Safety Report #4 f) added to Site Master File (Print and place in your Site Master File).
Date 2019.05.23 at 10.49 pm
Date 2019.05.07 at 14.35 pm
Updated EudraCT (including xml file for international sites) (print and place in your Site Master File #4b), eCRF baselineform (print and place in your Site Master File #2), and CLASSIC newsletter May 2019 (print and place in your Site Master File #13f)
Date 2019.03.26 at 09.00am
Updated kildedataliste (Danish) (print and place in your Site Master File #12)
Date 2019.03.25 at 10.45 am
Date 2019.03.01 at 13.02 pm
Newsletters posted (print and place in your Site Master File #13f)
Date 2019.02.18 at 12.54 pm
Date 2019.02.15 at 13.24 am
Updated EudraCT (print and place in your Site Master File #4b) and EudraCT xml (for national investigators). Updated Dayform in the eCRF (print and place in your Site Master File #2)
Date 2019.02.07 at 11.22 am
Date 2019.01.24 at 10.30 am
Leaflet for clinicians/nurses (English) #9b v) added to Site Master File (Print and place in your Site Master File at international sites)
Date 2019.01.10 at 10.00am
Date 2019.01.08 at 09.40 am
Date 2019.01.04 at 11.50 am
Approved protocol v.2.2 #1 added to Site Master File (Print and place in your Site Master File)
Danish trial information for relatives and patients v 1.3 #7 added to Site Master File (Print and place in your Site Master File)
Danish consent forms for relatives and patients v. 1.1 #7 added to Site Master File (Print and place in your Site Master File)
Danish curriculum vitae template v.1.1 #3 added to Site Master File (Print and place in your Site Master File)
eCRF dayform and withdrawal form updated #2 added to Site Master File (Print and place in your Site Master File)
Danish delegation log updated v 1.3 #3 added to Site Master File (Print and place in your Site Master File)
Consent ‘samtykke drejebog‘ added to Site Master File (Print and place in your Site Master File)
Date: 2018.12.18 at 10.30 am
Curriculum vitae (Danish) v.1.1 #3 added to Site Master File (Print and place in your Site Master File)
Date: 2018.12.13 at 10.30 am
Date: 2018.12.11 at 10.50 am
Date: 2018.12.04 at 11.06 am
