Trial documents

Protocol

Version 02.12.25 (active) 

Data collection, REDCap instruments with overview of data variables

Case Report Form, Primary Database, Digital Consent Forms, Follow-up data, Death Outcomes, and SUSAR (current active version) 

Information, consent forms, and your rights as a participant (danish and english)

Patient information and consent form

• Danish Version 02.12.25

• English Version 02.12.25

Surrogate information and consent form (current active version)

• Danish Version 02.12.25

• English Version 02.12.25

Your rights as a participant in a clinical trial with medical products

• Danish Version 01.09.25

• English Version 01.09.25