Table of Content (1 through 17) (download)
Site specific = each site need to add their own local or national documents to some of the Site Master File sections.
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1) Protocol and trial synopsis
b) Approved amendments (HOT-COVID)
2) CRF (for instruction, please see 9.a.iii)
3) Trial participants
a) Delegation- and signature-log (in Danish click here)
b) Training log
c) Curriculum Vitae for all personnel (template) (in Danish click here)
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)
5) Collaboration agreement
a) Collaboration agreement between Sponsor and site (site specific)
b) Approval from head of department (template) (in Danish click here)
c) Other relevant contracts (site specific)
6) Financial affairs
a) Case money (template)
b) Patient insurances (site specific)
7) Information to participants
a) Patient information (English and other languages) (in Danish click here)
b) Consent forms (site specific) (in Danish Samtykke skabelon, Samtykke log, Samtykke drejebog)
8) Co-enrolment and substudies
a) Co-enrolment Form (with access to Co-enrolment List)
b) Quality criteria for substudies
c) Substudy proposal form (template)
9) Trial documents
a) Trial instructions
i) Eligibility
ii) Screening and randomisation
iii) eCRF
iv) SUSAR
b) Pocket cards, documents for a notice board in the department
i) Oxygenation target for notice board ( in Danish click here)
ii) Inclusion and exclusion criteria for notice board (in Danish click here)
iii) Pocket cards (in Danish click here)
iv) Leaflet for all clinicians (in Danish Folder fagpersonale)
v) Sign for bed (in Danish click here)
vi) FiO2 conversion tables for open systems
vii) Identification log (drawn from the eCRF-system OpenClinica)
c) Educational material (power point presentations)
Background
Design and organisation
Screening and randomization
Adherence to oxygenation target
Trial withdrawal and SUSAR
Data entry
Discharge/transfer/death
Follow-up
ii) Information for nurses (in Danish click here)
10) Trial Medication
a) Summary of product characteristics (in Danish click here for Summary)
11) Laboratory tests (template)
12) Primary data source (in Danish click here)
13) Communication
a) HOT-ICU Contact details – Steering Committee
b) Contact details – eight countries
c) Note to file send to Sponsor (template)
d) Note to file received from Sponsor (template)
e) Other correspondences between Sponsor and site(s) (site specific)
f) News letters
g) Investigator meeting
14) Suspected unexpected serious adverse reactions
a) SUSAR form
b) Standard operating procedure for SUSAR reporting (in Danish click here)
c) Documentation for reporting of SUSAR (site specific)
15) GCP unit
a) Contacts (monitors/GCP units) (site specific) (in Danish click here)
b) Monitoring visits (template)
c) Monitoring reports (site specific)
d) Monitoring plan (in Danish click here)
e) Approval of trial initiation (site specific)
f) Correspondence with the monitor (e.g. GCP-unit) (site specific)
16) Trial completion
17) Appendices
a) Standard operating procedure (SOP) for EuroQol follow-up (in Danish click here)