study documents
Study protocol and synopsis
Statistical analysis plan (SAP)
Data Monitoring and Safety Committee
Case Report Form (CRF)
Approvals
Collaboration agreement
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 (Danish; version 1.1)