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

Print version of log of changes

Date: 21.01.2021: Added: annual safety report 2020

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)