classic LOG for site master file

CLASSIC Log for new documents and/or new versions updated:

Print version – please notice the “download” feature is situated underneath the pdf.

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 11.06.21 at 12.45 Updated Danish Medicine Agency (approved amendments) and Danish “forsøgspersoners rettigheder

Date 13.04.21 at 15.33 Updated EudraCT and EudraCT xml and added annual safety report 2021

Date 23.03.21 at 14.20 Updated co-enrolment list

Date 01.03.21 at 10.16 Updated EudraCT, EudraCT xml and Danish ethics committee amendments.

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 04.11.20 at 09.55
Added updated screening form and discharge form

Date 29.06.20 at 11.27
Added approved amendments from Ethics Committe to site master file #4c

Date 24.06.2020 at 12.45 pm
Added Annual Safety report and updated CLASSIC newsletters

Date 01.05.2020 at 10.06 am

Added eCRF Consent form to site master file #2

Date 20.01.2020 at 14.07 pm
Updated CLASSIC newsletter

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

New documents for 1-year follow-up available in Site Master File #17 Appendices  and updated #4c amendment from Danish Ethics Committee 

Date 22.11.2019 at 10.37pm

Updated #6a CLASSIC case-money form (Danish)

Date 11.11.2019 at 12.46pm

Updated #9c CLASSIC Initiation (power point)

Date 25.09.2019 at 10.24am

Updated #6a CLASSIC Case-money Form

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

Updated #6 CLASSIC Case-money Form

Date 2019.06.06 at 9.45am

Updated #13a Contact details – Steering Committee

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).

Data verification plan (English) added to National investigator documents.

Date 2019.05.23 at 10.49 pm

Updated Co-enrolment list

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

Updated “forsøgspersoners rettigheder”  (print and place in your Site Master File #7)

Date 2019.03.01 at 13.02 pm

Updated monitoring plan (danish) and monitoring plan (english) (print and place in your Site Master File #15d)

Newsletters posted (print and place in your Site Master File #13f)

Date 2019.02.18 at 12.54 pm

Updated version of CLASSIC classic-contact-details/ #13b

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

Updated version of CLASSIC contact details – Steering Committee

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

Letter of acknowledgement of notification, The Danish Medicines Agency (Danish) #4a added to  Site Master File (Print and place in your Site Master File)

Date 2019.01.08 at 09.40 am

Approved amendment from Danish Ethics Committee #4c added to Site Master File (Print and place in your Site Master File)

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

Primary data source (blank) #12 added to Site Master File

Date: 2018.12.11 at 10.50 am

CLASSIC pocket cards #9, CLASSIC pocket cards (Danish) #9 , (print and place in your Site Master File)

Date: 2018.12.04 at 11.06 am

 CLASSIC initiation power point #9, CLASSIC initiation power point for nurses #9 , (print and place in your Site Master File)