GODIF – log for new documents and/or new updated versions in site master file.

Print version of log of changes

Date: 10.05.2021: Added an approved GODIF protocol version 2.6 (site master file #1a), approval from The Committees on Health Research Ethics (#4c) and the Danish Medicine Agency (#4a), new EudraCT (#4b), consent forms (#7b) and trial information with up-dated protocol version (#7a), updated SOP for trial medication (#9avi), pocket cards (#9biv), leaflet for clinical staff (#9bv), and eligibility (#9ai), GODIF algorithms (#9avii), GODIF trial medication for notice board (#9bi). Table for ideal body weight and 5% fluid overload according to height (#9bviii) – has changed name to: Table for minimum fluid overload on inclusion and goal for fluid removal – an up-dated document is added. Bedside worksheet is withdrawn/obsolete (#9bvii).

Date: 21.01.2021: Added: annual safety report 2020 (site master file #4f)

Date: 08.01.2021: Added: an updated Trial medication dispensing system (site master file #9aiii)

Date: 05.01.2021: Added: data verification plan (site master file #15d) and Front page of protocol signed (site master file #1d).

Date: 04.01.2021: Added: protocol 2,5 (site master file #1a), Approval from The Danish Medicine Agency (site master file #4a), EudraCT (site master file 4b), Approval from The Committees on Health Research Ethics (site master file #4c), Trial information (site master file #7a), Consent forms (site master file #7b), Eligibility (site master file #9ai), SAE,SAR,SUSAR and unblinding (site master file #9av), SOP for trial medication (site master file #9avi), Algorithms for trial medication and resuscitation (site master file #9avii), Inclusion and exclusion criteria for notice board (site master file #9bii), Pocket cards (Danish) (site master file #9biv), Leaflet for clinical staff (Danish) (site master file #9bv), Initiation for investigators and primary trial personnel (slides) (site master file #9ci), Primary data source (template and for Sundhedsplatformen) (site master file #12)

Date: 10.12.2020: Added an updated co-enrolment list (site master file #8a)

Date: 13.10.2020: Added a new plan for data verification from the GCP-unit and a new template for the day form to the eCRF (site master file #15d and #2)

Date: 28.09.2020: Added SOP for trial medication, SOP for escape procedures, and GODIF algorithms in Danish (site master file #9vi and 9vii)

Date: 15.09.2020: Added an updated co-enrolment list (site master file #8a)

Date: 27.08.2020: Added: new EudraCT file and up-dated approvals and correspondence from The Danish Medicine Agency and The Committees on Health Research Ethics (site master file #4b, #4a, #4c)

Date: 19.08.2020: Added: Instructions in the eCRF (site master file #9aiv)