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

Uploaded updated Protocol ver. 4.3, Danish protocol ammendment version 5.0, approval of protocol 4.3 from Danish Medicines Agency and Comittee on Health Research Ethics, Updated EudraCT form, Updated version of ‘Forsøgspersoners rettigheder’.

Date: 2021.01.07 13:21 pm

Uploaded Newsletter November+December 2020 and Annual Safety report 2020 please print and archive in SMF section 13f and 4f

Date: 2020.12.10 13:01 pm

Uploaded presentation for Interim meeting

Revised Trial Documents Layout

Uploaded Danish version of Information til sygeplejersker

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

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

(print document(s) and place in your Site Master File)

Date: 2020.04.17 at 14:36 pm

Updated co-enrolment list #8a

(print document(s) and place in your Site Master File)

Date: 2020.03.10 at 12:57 pm

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

(print document(s) and place in your Site Master File)

Date: 2019.12.20 at 13:22 pm

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

(print document(s) and place in your Site Master File)

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

(print document(s) and place in your Site Master File)

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

(print document and place in your Site Master File)

Date: 2019.03.26 at 11.56 am

Updated version of Forsøgspersoners rettigheder (danish) #7a

(print document and place in your Site Master File)

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

(print document and place in your Site Master File)

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

(print document(s) and place in your Site Master File)

Date: 2018.11.15 at 12.45 pm

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

(print document(s) and place in your Site Master File)

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)