COVID STEROID log for Site Master File

Print version – please notice the “download” feature is situated below the document

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