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Log for new documents and/or new versions updated:
Print version – please notice the “download” feature is situated underneath the pdf.
Date 2023.05.26 at 08.36 am.
The Danish Medicines Agency letter of acknowledgement of notification – Approval of HOT-COVID stop for new randomisations
The Danish Medicines Agency letter of acknowledgement of notification – Approval of HOT-ICU extension
The Danish Medicines Agency letter of acknowledgement of notification – Approval of HOT-ICU protocol version 2.4
Date 2023.03.06 at 09.31 am.
Date 2023.02.21 at 11.44 am.
Annual Safety Report #1 & #5, (print and place in your Site Master File)
Date 2023.01.12 at 09.20 am.
Date 2022.05.07 at 09.20 am.
Date 2022.04.05 at 01.15 pm.
Annual Safety Report #4, (print and place in your Site Master File)
Date 2022.01.21 at 10.58 am.
Co-enrolment list #8a (go to 8.a Co-enrolment Form and find a link to the list in the text)
Date 2021.11.04 at 10.36 am.
News letters (#7 & #8 #9 & #10 & #11) 13.f
Date 2021.05.12 at 11.38 am.
Date 2021.03.10 at 09.34 am.
Date 2021.02.01 at 02.19 pm.
Plan for Monitoring version 1 (in English), Data Verification Plan version 1 (in English)
Date 2021.01.15 at 11:00 am
Print and place all updated files in your Site Master File
Date 2020.12.18 at 07.39 am.
Date 2020.12.10 at 05.45 pm.
Date 2020.12.07 at 01.05 pm.
Date 2020.08.13 at 09:24 am
News letter (#32 HOT-ICU & #1 HOT-COVID) 13.f
Date 2020.11.16 at 02:35 pm
Date 2020.11.04 at 09:05 am
Co-enrolment list #8a (go to 8.a Co-enrolment Form and find a link to the list in the text)
Date 2020.10.08 at 09:30 am
Co-enrolment list #8a (go to 8.a Co-enrolment Form and find a link to the list in the text)
Date 2020.08.25 at 11:43 am
Date 2020.08.13 at 09:24 am
Print and place all updated files in your Site Master File
Date 2020.08.12 at 11:09 am.
Update with HOT-COVID related documents:
HOT-COVID protocol 1.2 (approved), EudraCT, Delagation log (English and Danish version), CV (English and Danish versions), Approval from head of department template (English and Danish versions), Case money template, Patient information template (HOT-COVID) English version, Patient Information til patient, pårørende og forsøgsværge #7.a (in Danish), Samtykke (HOT-COVID) patienten, pårørende og anden forsøgsværge, første forsøgsværge #7.b (in Danish), Samtykke drejebog (in Danish), Co-enrolment form, HOT-COVID substudy proprosal template, HOT-COVID eligibility criteria, Instructions for SUSAR reporting, Sign for bed (in Danish), Sign for board (in Danish), FiO2 conversion table for open systems, HOT-COVID pocket cards (English and Danish versions), HOT-COVID leaflet for clinicians (English and Danish versions), HOT-COVID Laboratory test template, HOT-COVID Primary data source list (English and Danish versions), HOT-COVID contact details, Note to file template, HOT-COVID monitoring visit template
Date 2020.07.07 at 10:38 am
Date 2020.07.07 at 08:30 am
News letter (#30) 13.f (print and place in your Site Master File)
Date 2020.06.22 at 01:03 am
Date 2020.06.18 at 02:48 pm
Annual Safety Report #4, (print and place in your Site Master File)
Date 2020.06.16 at 12:52 am
Co-enrolment list #8a (go to 8.a Co-enrolment Form and find a link to the list in the text)
Date 2020.06.12 at 08:46 am
News letters (#27-29) 13.f (print and place in your Site Master File)
Date 2020.06.08 at 09:10 am
Date 2020.05.25 at 11:50 am
Date 2020.04.15 at 10:30 am
Co-enrolment list #8a (go to 8.a Co-enrolment Form and find a link to the list in the text)
Date 2020.03.24 at 08:15 am
Date 2020.03.24 at 02:42 pm
Date 2020.03.06 at 02:45 pm
News letters (#25+26) 13.f (print and place in your Site Master File)
Date 2020.01.09 at 12:06 am
HOT-ICU Monitoring and Dataverification Plan (English) (version 3.1)
Date 2020.01.08 at 12:17 am
HOT-ICU Monitoring and Dataverification Plan (Danish and English) (no new files added), News letters (23+24) 13.f
Date 2020.01.07 at 08:03 am
Co-enrolment list #8a (go to 8.a Co-enrolment Form and find a link to the list in the text)
Date 2020.01.06 at 09:35 am
Co-enrolment list #8a (go to 8.a Co-enrolment Form and find a link to the list in the text)
Date 2019.12.18 at 02:49 pm
Co-enrolment list #8a (go to 8.a Co-enrolment Form and find a link to the list in the text)
Date 2019.12.17 at 09:22 am
Co-enrolment list #8a (go to 8.a Co-enrolment Form and find a link to the list in the text)
Date 2019.12.06 at 10:30 am
Co-enrolment list #8a (go to 8.a Co-enrolment Form and find a link to the list in the text)
Date 2019.11.19 at 10:14 am
HOT-ICU_monitorerings- og dataverifikationsplan , Monitoreringsplan version 2, 1. Tillæg til Monitorerings plan verison 2 and Plan for dataverifikation version 7 (Danish only) #15.d
Print and place all updated files in your Site Master File
Date 2019.11.07 at 10:10 am
Co-enrolment list #8a (go to 8.a Co-enrolment Form and find a link to the list in the text)
Date 2019.09.04 at 09:19 am
Co-enrolment list #8a (go to 8.a Co-enrolment Form and find a link to the list in the text)
Date 2019.14.08 at 1.05 pm
Contact details #13.a, (print and place in your Site Master File)
Annual Safety Report #4, (print and place in your Site Master File)
Date 2019.11.07 at 8.35 am
Co-enrolment list #8a (go to 8.a Co-enrolment Form and find a link to the list in the text)
Date: 2019.01.07 at 1.35 pm
Date: 2019.18.06 at 11.15 am
News letter 13.f, (print and place in your Site Master File)
Date: 2019.06.06 at 3.49pm
Date: 2019.05.22 at 10.35 am
Date: 2019.04.10 at 03:50 pm
Contact details #13.a, (print and place in your Site Master File)
Date: 2019.04.02 at 02:59 pm
and News letter #13.f, (print and place in your Site Master File)
Date: 2019.03.20 at 12.50 pm
News letters #13.f, (print and place in your Site Master File)
Date: 2019.02.01 at 09.50 am
Date: 2018.12.19 at 02.20 pm
Date: 2018.11.22 at 02.00 pm
Co-enrolment list #8.a (go to 8.a Co-enrolment Form and find a link to the list in the text)
Date: 2018.11.16 at 01.30 pm
Date: 2018.11.07 at 09.30 am
and News letters #13.f, (print and place in your Site Master File)
Date: 2018.11.01 at 11.10 am
Co-enrolment list #8.a (go to 8.a Co-enrolment Form and find a link to the list in the text)
Date: 2018.10.22 at 1.30 pm
Date: 2018.10.05 at 1.50 pm
Date: 2018.09.26 at 12.15 am
Annual Safety Report #4, (print and place in your Site Master File)
Date: 2018.09.12 at 1.15 pm
Date: 2018.09.04 at 9.15 am
News letters #13.f, (print and place in your Site Master File)
Date: 2018.08.29 at 3.15 pm
Date: 2018.08.21 at 10.45 am
Date: 2018.07.03 at 8.45 am
News letters #13.f, (print and place in your Site Master File)
Date: 2018.06.13 at 4.10 pm
Co-enrolment list #8.a (go to 8.a Co-enrolment Form and find a link to the list in the text), News letters #13.f (print and place in your Site Master File)
Date: 2018.04.17 at 12.15 pm
Date: 2018.02.09 at 6.45 pm
News letters #13.f, (print and place in your Site Master File)
Date: 2018.02.02 at 2.00 pm
IF you want to print at whole new set of all CRF documents then your find them here:
Date: 2018.01.05 at 5.15 pm
Date: 2017.12.06 at 4.40 pm
Table of content (print and place in your Site Master File)
Date: 2017.11.17 at 4.15 pm
News letters #13.f, (print and place in your Site Master File)
Date: 2017.11.16 at 12.00 am
The Co-enrolment list is no longer part of the Site Master File – to get access to the list a link is to be found in the Co-enrolment Form document #8.a (remove Co-enrolment list from the Site Master File), Table of content (print and place in your Site Master File)
Date: 2017.11.08 at 3.30 pm
Date: 2017.11.08 at 8.30 am
Date: 2017.11.02 at 11.30 am
Date: 2017.10.24 at 1.00 pm
Co-enrolment list #8a (print and place in your Site Master File)
Date: 2017.10.17 at 8.00 pm
Case money #6 (print and place in your Site Master File)
Date: 2017.10.03 at 3.45 pm
Date: 2017.09.20 at 0.15 am
News letters #13.f, (print and place in your Site Master File)
Date: 2017.09.08 at 3.45 pm
Date: 2017.08.31 at 12.30
Date: 2017.08.28 at 3.00 pm
Date: 2017.08.21 at 4.15 pm
Patient information (template), #7.a, Table of content (print and place in your Site Master File)
Date: 2017.08.16 at 11.15 am
Date: 2017.08.14 at 2.00 pm
CRF – all in one document (Swiss version) #2(1), Screening form (Swiss Screening form) #2 (2), Baseline form #2(2), Daily form #2(2), Table of content (print and place in your Site Master File)
Date: 2017.08.11 at 12.00 am
Remove: Collaboration agreement between Sponsor and site,#5.a (remove from Site Master File)
Date: 2017.07.18 at 9.00 pm
Receipt of notification #4.a (print and place in your Site Master File)
Date: 2017.07.03 at 18.00 pm
Date: 2017.06.19 at 8.00 am
