Site Master File
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
b) Approval from head of department (Danish)
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 trial guardians, relatives and patient (Danish) (English).
b) Consent form from trial guardian, relatives and patients (Danish) (English).
c) The rights of the patient in clinical research (Danish)
8) Co-enrolment and sub-studies
a) Co-enrolment Form (with access to co-enrolment list)
b) Quality criteria for sub-studies
c) Sub-study proposal form
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)
b) Pocket cards, documents for a notice board in the department
i) Trial medication for notice board
ii) Inclusion and exclusion criteria for notice board
iii) Trial synopsis for notice board
iv) Pocket cards (Danish) (English)
v) Leaflet for clinical staff (Danish) (English)
vi) Sign for bed
Vii) Bedside worksheet (withdrawn/obsolete)
c) Educational material (power point presentations)
i) Initiation for investigators (slides) and for primary trial personnel (slides)
ii) Screening and randomisation
iii) Trial medication dispensing (Danish slides) (English slides)
iv) Data entry
v) Withdrawal
vi) SAE/SAR/SUSAR and unblinding
d) Procedures
i) Approved procedures by sponsor
ii) Procedure for obtaining consent (for Danish sites)
10) Trial medication
a) Labels for infusion or bolus injection
b) Summary of product characteristics for Meropenem and Piperacillin/Tazobactam (in Danish)
c) Receipt of trial medication (ikke nødvendig, da forsøgsmedicinen allerede er på lager)
d) Trial drug disposal form (vel ikke nødvendig for empress, når ingen lagerbeholdning)
11) Laboratory tests
Not relevant for EMPRESS
12) Primary data source (template) and data source for Sundhedsplatformen
13) Communication
a) Contact details – Management Committee
b) Contact details – participating sites
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) Newsletters
g) Correspondence to primary investigators and primary trial personnel (e-mails)
14) Serious adverse events and suspected unexpected serious adverse reactions
a) SAE/SAR/SUSAR report form
b) Documentation for reporting of SAE/SAR/SUSAR (site specific)
15) GCP unit
a) Contacts (monitors/GCP units) (site specific)
b) Monitoring visits (template)(English)
c) Monitoring reports (site specific)
d) Monitoring plan (English) and data verification plan (English)
e) Approval of trial initiation (site specific)
f) Correspondence with the monitor (e.g. GCP-unit) (site specific)
g) Collaboration agreement between sponsor and GCP-unit
16) Trial completion
17) Appendices
a) SOP for follow-up
b) EQ-5D-5L questionnaire for 6 months follow-up
c) MoCA mini test and instructions