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AID-ICU LOG for new documents and/or new versions updated
Print version – please notice the “download” feature is situated underneath the pdf.
Date: 2021.06.08 12:50 pm
Uploaded AID-ICU Newsletters, please print and archive in SMF section 13e
Date: 2021.03.29 10:11 am
Uploaded approval from Danish Dataprotection Agency, please print and insert in SMF section 4c.
Date: 2021.03.24 18:31 pm
Date: 2021.01.07 13:21 pm
Date: 2020.12.10 13:01 pm
Uploaded SAR/SUSAR instructions ver. 3
Date: 2020.11.11 at 11:15 am
Uploaded Newsletters May/June/July and August/September/October
Date: 2020.09.15 at 12:55 pm
Date: 2020.05.18 at 13:38 pm
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Date: 2020.04.17 at 14:36 pm
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Date: 2020.03.10 at 12:57 pm
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Date: 2019.12.20 at 13:22 pm
Uploaded SOP Obtaining EQ-5D-5L #9avi
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(print document(s) and place in your Site Master File)
Date: 2019.09.03 at 14.00 pm
Date: 2019.08.16 at 13.00 pm
Date: 2019.07.17 at 07.40 am
Date: 2019.05.10 at 14.40 pm
Receipt of received safety report from Danish Medicines Agency and Health Research Ethics #4d, Approval of 1. amendment Danish Dataprotection Agency (danish) #4c (print document(s) and place in your Site Master File)
Date: 2019.04.12 at 13.18 pm
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Date: 2019.03.26 at 11.56 am
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Date: 2019.03.22 at 9.56 am
Date: 2019.03.19 at 1.08 pm
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Date: 2019.03.05 at 3.12 pm
Revised #13a AID-ICU Steering Committee (print document and place in your Site Master File)
Date: 2019.03.05 at 1.47 pm
Date: 2019.01.24 at 12.54 am
Date: 2019.01.08 at 14.05 pm
Date: 2018.12.12 at 10.31 am
Date: 2018.12.11 at 12.55 pm
Date: 2018.11.30 at 14.20 pm
Date: 2018.11.27 at 16.10 pm
(print document(s) and place in your Site Master File)
Date: 2018.11.15 at 12.45 pm
(print document(s) and place in your Site Master File)
Date: 2018.11.09 at 13.45 pm
Date: 2018.11.09 at 11.34 am
Date: 2018.10.31 at 4.00 pm
Date: 2018.09.28 at 1.30 pm
Drug disposal form #10.c (print document(s) and place in your Site Master File)
Date: 2018.09.26 at 5.00 pm
Date: 2018.09.20 at 8.45 am
eCRF Baseline #2 (print document(s) and place in your Site Master File)
Date: 2018.09.14 at 5.20 pm
Date: 2018.09.12 at 5.15 pm
Date: 2018.09.11 at 1.45 pm
Date: 2018.09.06 at 11.15 am
The Danish Medicine Agency (in Danish, the top three documents are new) #4.a, Videnskabsetisk komité (in Danish, the top two documents are new) #4.c. (print document(s) and place in your Site Master File)
Date: 2018.08.30 at 12.00 am
Approval of amendments from ethic committee has mistakenly been misplaced as amendments for the protocol – There are no amendments for the protocol #1.b., and the amendments – The committees on health research ethics and Den videnskabsetiske komité (in Danish) are moved to their right environment # 4.c. – apologize for the inconvenience.
Deltagerinformation forsøgsværge, pårørende og patienten (in Danish) #7.a., Samtykke drejebog (in Danish) #7.b. (print document(s) and place in your Site Master File)
Date: 2018.07.26 at 2.45 pm
Samtykke patienten, Samtykke 1. forsøgsværge, Samtykke 2. forsøgsværge, og Samtykke pårørende (all in Danish) #7.b and for national investigators only the .xml file for EudraCT is now available in “National Investigator Documents” (print document(s) and place in your Site Master File)
Date: 2018.07.02 at 9.15 am
Lommekort (in Danish) #9.b.iv (print document(s) and place in your Site Master File)
Date: 2018.06.20 at 1.00 pm
Date: 2018.05.04 at 4.00 pm
Date: 2018.04.24 at 3.40 pm
Godkendelse af tillægsprotokol VEK, #4.c (in Danish) (print document(s) and place in your Site Master File)
Date: 2018.04.23 at 12.30 pm
AID-ICU trial documents are now accessible at the homepage. Access to “Documents for National investigator” will still require a password to get access (you may e-mail to contact@cric.nu to get password) (print document(s) and place in your Site Master File)
