HOT-ICU & HOT-COVID The Danish Medicines Agency Approval

To download document find link just below document.

In total 16 documents

 

Letter of acknowledgement of notification – Approval of HOT-COVID stop for new randomisations

Letter of acknowledgement of notification – Approval of HOT-ICU extension

Letter of acknowledgement of notification – Approval of HOT-ICU protocol version 2.4

Letter of acknowledgement of notification – Approval of HOT-ICU protocol version 2.3

Letter of acknowledgement of notification – Approval of HOT-ICU protocol version 2.2

Letter of acknowledgement of notification – Approval of HOT-COVID amendment

Letter of acknowledgement of notification – Extension of trial

Letter of acknowledgement of notification

Letter of acknowledgement of notification

Letter of acknowledgement of notification

Letter of acknowledgement of notification

Letter of acknowledgement of notification

Letter of acknowledgement of notification

The Danish Medicines Agency approval – “Letter of Approval, Condition met” and “Letter of Conditional Approval” – combined into one document (pdf) just below (see also supplementary mail further down).

Supplementary mail receipt of revised participant information and informed consent.

Receipt of notification, 2017-000632-34, July 5, 2017