study documents

Study protocol and synopsis

Study protocol (version 1.7)

Study synopsis (version 1.7)

Data Monitoring and Safety Committee

Charter for the independent Data Monitoring and Safety Committee (DMSC)

Case Report Form (CRF)

eCRF in REDCap (for Danish sites)

eCRF in REDCap (for sites outside of Denmark)

Example of the 8 hour oxygen interventions

Example of the data collection sheet (version 1.0) during the 8 hour oxygen intervention

Approvals

The Danish Research Ethics Committee (H-21018062)

The Danish Medicines Agency

EudraCT (2021-000556-19)

Knowledge Center on Data Protection (in the Capital Region of Denmark)

Collaboration agreement

Collaboration agreement between sponsor and trial site (template)

Trial participants

Trial information to the study guardian (Danish; version 1.1)

Trial information to the trial participant’s next-of-kin (Danish; version 1.3)

Trial information to the trial participant (Danish; version 1.2)

Proxy consent form by the 1st study guardian before inclusion (Danish; version 1.0)

Proxy consent form by the 2nd study guardian after inclusion (Danish; version 1.0)

Proxy consent form by the trial participant’s next-of-kin (Danish; version 1.1)

Informed consent form by the trial participant’s (Danish; version 1.1)