Table of Content (download)
Please see LOG for latest up-loads of new documents and/or new versions of documents in Site Master File
1) Protocol and trial synopsis
b) Approved amendments (in Danish click here)
2) CRF (for instruction, please see 9.a.iv.)
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
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 (template)
b) Approval from head of department (template)(in Danish click here)
c) Other relevant contracts (site specific)
6) Financial affairs
a) Case money (international) and Case money (DKK)
b) Patient insurances (site specific)
7) Information to participants
a) Patient information (template) (in Danish click here)
b) Consent form (site specific) (in Danish click here)
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) Trial medication
iv) eCRF
v) SAR/SUSAR
vi) SOPS
b) Pocket cards, documents for a notice board in the department
i) Trial medication for notice board (in Danish click here)
ii) Inclusion and exclusion criteria for notice board (in Danish click here)
iii) Trial synopsis for notice board
iv) Pocket cards (in Danish læger/sygeplejersker)
v) Leaflet for clinicians/nurses (in Danish læger/sygeplejersker)
vi) Sign for bed
c) Educational material (power point presentations)
i) Initiation
ii) Screening and randomisation (see initiation)
iii) Trial medication dispensing (in Danish click here)
iv) Data entry (see initiation and trial instructions eCRF)
v) Withdrawal (see initiation and trial instructions SAR/SUSAR)
vi) SAR/SUSAR and un-blinding
vii) Information for nurses (in Danish click here)
10) Trial Medication
a) Labels
b) Summary of product characteristics (in Danish click here)
d) Receipt of trial medication
e) Instruction for temperature logger
11) Laboratory tests (not relevant for AID-ICU)
12) Primary data source (in Danish click here)
13) Communication
b) Contact details – Denmark – Finland – UK – Italy – Spain
c) Note to file (template)
d) Other correspondences between Sponsor and site(s) (site specific)
e) Newsletters
14) Serious adverse reactions ans suspected unexpected serious adverse reactions
b) Documentation for reporting of SAR/SUSAR (site specific)
15) GCP unit
a) Contacts (monitors/GCP units) (site specific) (in Danish click here)
b) Monitoring visits (template) (in Danish click here)
c) Monitoring reports (site specific)
d) Monitoring plan and Plan for data-verification (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
Site specific = each site need to add their own local or national documents to some of the Site Master File sections.