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Date 03.10.2022 at 15.30 pm
Added #13d Note to file received from Sponsor
Date 04.07.2022 at 08.45 pm
Added #16 Trial completion
Date 10.05.2021 at 19.35 pm
Termination of trial to the #4a the Danish Medicine Agency and the #4c The Committees on Health Research Ethics.
Date 04.11.2020 at 14.30 pm
Updated approvals from #4a the Danish Medicine Agency
Date 11.06.2020 at 09.43 am
Added #9a,iv Guide to data entry in eCRF
Date 03.06.2020 at 14.35 pm
Added #5a Collaboration agreement between Sponsor and National Coordinator for international sites
Date 20.05.2020 at 14.20 pm
Added #13f Newsletter 3 and Newsletter 4
Date 20.05.2020 at 13.49 pm
Updated approvals from #4a the Danish Medicine Agency, #4b EudraCT and #4c The Committees on Health Research Ethics.
Date 20.05.2020 at 13.49 pm
Updated #1a approved protocol, #1b approved amendment, and #1d front page to sign by primary investigator
Date 15.05.2020 at 15.06 pm
Updated #12 Primary data source template and for Sundhedsplatformen
Date 15.05.2020 at 15.05 pm
Updated #10c Trial medication log
Date 12.05.2020 at 11.39 am
Updated #13g Correspondence to primary investigators and primary trial personnel
Date 04.05.2020 at 11.12 am
Updated #9b,i Trial medication for notice board
Date 04.05.2020 at 10.44 am
Updated #0 Table of Contents
Date 01.05.2020 at 15.40 pm
Updated #13g Correspondence to all sites
Date 30.04.2020 at 21.06 pm
Added #2 eCRF: Consent form
Date 29.04.2020 at 08.06 am
Added #2 eCRF: Screening, Baseline, Administered Trial Medication day 1-7, Dayforms 1-14, Withdrawal, Discharge and readmission, Follow-up day 28, Follow-up day 90, Follow-up 1-year
Date 24.04.2020 at 12.14 pm
Added #3b training log signed by Sponsor for primary investigators and primary trial personnel
Date 24.04.2020 at 12.14 pm
Added #10d Trial medication preparation
Date 23.04.2020 at 15.55 pm
Updated #4c Approved amendments from the Committees on Health Research Ethics
Date 23.04.2020 at 15.49 pm
Updated #4a Approvals from the Danish Medicine Agency
Date 22.04.2020 at 19.48 pm
Added #15d Data verification plan
Date 21.04.2020 at 13.20 pm
Updated #7a Trial information for trial guardian, relatives and patients
Date 21.04.2020 at 12.58 am
Updated #7b Consent form to first trial guardian, second trial guardian, relatives and patients
Date 21.04.2020 at 10.08 am
Updated #12 Source data list
Date 21.04.2020 at 10.04 am
Updated #12 Source data list for Sundhedsplatformen
Date 17.04.2020 at 17.41 pm
Added #13f Newsletter 2
Date 16.04.2020 at 20:11 pm
Updated #8a co-enrolment list
Date 16.04.2020 at 14.27 am
Updated Table Content
Date 16.04.2020 at 14.11 am
Updated slides for infusion with placebo #9c,iii Trial medication handling
Date 16.04.2020 at 10.54 am
Added document to #9a,v SAE, SUSAR and unblinding
Date 16.04.2020 at 9.48 am
Added document to #9a,ii Screening and randomisation
Date 16.04.2020 at 9.46 am
Updated #3a Delegation- and signature-log
Date 15.04.2020 at 20:07 pm
Updated #9d,iii Procedure for obtaining consent
Date 15.04.2020 at 15.50 pm
Updated #7c Further data registration form for patients and relatives
Date 15.04.2020 at 13.28 am
Added slides to #9c,iii for dispensing trial medication
Date 15.04.2020 at 13.19 am
Updated #9d,i procedure for system failure
Date 15.04.2020 at 11.15 am
Updated #8a Co-enrolment form
Date 15.04.2020 at 10.57 am
Added Screenings formula for #9a,ii randomisation procedure if system failure occurs.
Date 15.04.2020 at 10.03 am
Updated #4b EudraCT (pdf) and xml versions
Date 14.04.2020 at 20:21 pm
Updated #8a co-enrolment list