AID-ICU LOG for Site Master File

AID-ICU LOG for new documents and/or new versions updated

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Date: 2020.09.15 at 12:55 pm

Uploaded updated version of co-enrolment list.

Date: 2020.05.18 at 13:38 pm

Uploaded ammendment (danish) Godkendelse for VEK no. 7 COVID-19 #4b

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Date: 2020.04.17 at 14:36 pm

Updated co-enrolment list #8a

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Date: 2020.03.10 at 12:57 pm

Uploaded Newsletter November/December 2019, Newsletter January/February 2020 and Safety Report for 2019.

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Date: 2019.12.20 at 13:22 pm

Uploaded SOP Obtaining EQ-5D-5L #9avi

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Date: 2019.11.04 at 14:06 pm, uploaded newsletter no. 7 #13f

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Date: 2019.09.03 at 14.00 pm

Uploaded Approval from Danish Ethics Committee #4b, SOP Acute Hepatic Failure #9avi, Newsletter no. 6 #13f  (print document(s) and place in your Site Master File)

Date: 2019.08.16 at 13.00 pm

Uploaded Newsletter 4 and Newsletter 5 #13e

Date: 2019.07.17 at 07.40 am

Updated Protocol version 4.2 dated 7 June 2019 and #1a, Approval from Danish Medicines Agency #4d

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

Updated versions of Pocket cards Læger ver. 5, Pocket Cards Sygeplejersker ver. 4 (danish) #9bv and updated Folder Læger ver. 2.0 (danish), Folder sygeplejerske ver. 2.0 (danish) #9bv

Updated version of educational material on Trial medication dispensation #9ciii

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Date: 2019.03.26 at 11.56 am

Updated version of Forsøgspersoners rettigheder (danish) #7a

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Date: 2019.03.22 at 9.56 am

Revised #9 a (i) Eligibility

Date: 2019.03.19 at 1.08 pm

1-year follow-up protocol cognitive function #1b and Newsletter_2  #13e and Newsletter_3 #13e

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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

Edit #13b contact details of national investigators (print document and place in your Site Master File)

Date: 2019.01.24 at 12.54 am

AID-ICU Case Money (DKK) #6a

Date: 2019.01.08 at 14.05 pm

Annual Safety Report 2018 #4f (print document(s) and place in your Site Master File)

Date: 2018.12.12 at 10.31 am

Revideret Godkendelse fra Datatilsynet #4c and Lommekort_Læger_v4 #9b (print document(s) and place in your Site Master File)

Date: 2018.12.11 at 12.55 pm

AID-ICU Protocol 4.1 #1b and Approval of Protocol 4.1 from Danish Medicine Agency #4a and Danish Committee on Health Research Ethics #4b (print document(s) and place in your Site Master File)

Date: 2018.11.30 at 14.20 pm

AID-ICU Trial Medication #9a and 1_Newsletter #13e (print document(s) and place in your Site Master File)

Date: 2018.11.27 at 16.10 pm

Delegation- and signature-log_v.1.2 #3a and Opgavefordelingsliste v.1.2 #3a and Forsøgspersoners_Rettigheder 2018 #7a

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Date: 2018.11.15 at 12.45 pm

Patient information template (english)_v2 #7a and Table of Content updated

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Date: 2018.11.09 at 13.45 pm

Samtykke-log_template_v2.0_09Nov2018.xlsx #7b (print document(s) and place in your Site Master File)

Date: 2018.11.09 at 11.34 am

Approved amendment ‘Protocol follow-up EQ-5D-5L #1.b (print document(s) and place in your Site Master File)

Date: 2018.10.31 at 4.00 pm

Protocol version 4.0 #1.a, SOPs #9.vi and Table of Content (print document(s) and place in your Site Master File)

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

Deltager information patienten, pårørende, forsøgsværge #7.a, Co-enrolment list #8.a, Lommekort for læger og sygeplejersker (for Danes only) #9.b.iv, and Sign for bed #9.b.vi (print document(s) and place in your Site Master File)

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

eCRF Discharge form #2, SAR/SUSAR #9.a.v, and SAR/SUSAR report form #14 (print document(s) and place in your Site Master File)

Date: 2018.09.12 at 5.15 pm

Guideline to notes and discrepancies in OpenClinica (in Danish click here) #2, CV template (Danish only), #3.c (print document(s) and place in your Site Master File)

Date: 2018.09.11 at 1.45 pm

Protocol amendment (for Danes only) #1.b., Collaboration agreement between Sponsor and site #5.a, Lommekort for læger og sygeplejersker (for Danes only) #9.b.iv, Contact information for GCP (for Danes only) #15.d, Table of content  (print document(s) and place in your Site Master File)

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

Table of content, Monitoring plan (in English) and Plan for data-verification (in English) #15.d (print document(s) and place in your Site Master File)

Date: 2018.05.04 at 4.00 pm

Table of content, CRF (Screening, Baseline, Day form, 90 days follow-up, 1 year follow-up, Discharge and readmission, Withdrawal) #2, EudraCT #4b, Etisk komite (Danish), #4.c, Approval head of department (in Danish Tilladelse afdelinsledelsen) #5.b, Primay data source (in Danish Kildedata) #12, Contact details #13.b, Monitoreringsplan (Danish) #15.d (print document(s) and place in your Site Master File)

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)