HOT-ICU Protocols and Approvals

Copied in from Site Master File:

1) Protocol and trial synopsis

a) Approved protocol

b) Approved amendments (HOT-COVID)

c) Trial synopsis

4) Approvals and correspondence

a) The Danish Medicines Agency

b) EudraCT

c) The Committees on Health Research Ethics (in Danish click here)

d) The Danish Data Protection Agency (Datatilsynet)

e) National and local approvals (site specific)

f) Annual Safety Report