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 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)