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1) Quality management
1.1) Approval from department
1.2) Trial specific guidelines
1.2.1 Short guideline to staff
1.2.2 Operational guideline, including local procedure about consent
1.2.3 Guideline for data entry
1.2.4 Guideline for obtaining 180-day consent
1.2.5 Additional documents to patient folder
1.3 Template for protocol deviations (note to file)
1.4 Approved documents, forms etc.
1.5 Other
1.5.1 Co-enrolment (list and forms)
2) Approval from authorities
2.1 Report for the Application Evaluation Decision
2.1.1 Initial application
2.1.2 Substantial and non-substantial modifications
2.2 Documentation for reporting to sponsor of serious breach, unexpected events and Urgets Safety Measure
Table of Content (1 through 17)
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1) Protocol and trial synopsis
c) Trial synopsis (Danish) (English)
2) eCRF (for instruction, please see 9.a.iv.)
3) Trial participants
a) Delegation- and signature-log (Danish) (English)
b) Training log (Danish) (English)
c) Curriculum Vitae for all personnel template (Danish) (English)
4) Approvals and correspondence
b) The Capital Region Knowledge Center for Data Compliance (Legal department)
c) National and local approvals (site specific)
d) Annual Safety Report
5) Collaboration agreement
a) Collaboration agreement between Sponsor and site (Denmark)
b) Approval from head of department (Denmark)
c) Other relevant contracts (site specific)
6) Financial affairs
a) Case money (Danish) (English)
b) Patient insurances (not needed for Danish hospitals)
7) Information to participants
a) Trial information to patient, relatives and trial guardian (Danish) (English).
b) Consent form to patient, relatives and trial guardian (Danish) (English).
c) The rights of the patient in clinical research (Danish)
8) Co-enrolment and sub-studies
a) Co-enrolment Form (English) (with access to Co-enrolment list)
b) Quality criteria for sub-studies (English)
c) Sub-study proposal form (English)
9) Trial documents
a) Trial instructions
i) Eligibility (Danish)
ii) Screening and randomisation
iii) Trial medication dispensing system and co-interventions
iv) Instructions for the eCRF and for sites providing their own trial drug
v) SAE, SAR, SUSAR and unblinding
vi) SOP for trial medication (Danish), SOP for escape procedures (Danish)