Site Master File
Table of Content (1 through 17)
Please see LOG for latest up-loads of new documents and/or new versions of documents in Trial Master File
1) Protocol and trial synopsis
d) Front page of protocol signed
2) eCRF (for instruction, please see 9.a.iv.)
3) Trial participants
a) Delegation- and signature-log (in Danish)
b) Training log (Danish)
c) Curriculum Vitae for all personnel (template) (in Danish)
4) Approvals and correspondence
b) EudraCT
c) The Committees on Health Research Ethics (in Danish). Approved amendments.
d) The Capital Region Knowledge Center for Data Compliance (Legal department) (only in Danish)
e) National and local approvals (site specific)
5) Collaboration agreement
a) Collaboration agreement between Sponsor and site
b) Approval from head of department (in Danish)
c) Other relevant contracts (site specific)
6) Financial affairs
b) Patient insurances (not needed for Danish hospitals)
7) Information to participants
a) Trial information to trial guardians, relatives and patient (in Danish).
b) Consent form to first trial guardian, second trial guardian, relatives and patient (in Danish).
c) The rights of the patient in clinical research (in Danish)
8) Co-enrolment and sub-studies
a) Co-enrolment Form (with access to co-enrolment list)
b) Quality criteria for sub-studies
9) Trial documents
a) Trial instructions
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)
Vii) Algorithms for trial medication and resuscitation (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 (English) (Danish)
vi) Sign for bed
Vii) Bedside worksheet (withdrawn/obsolete)
viii) Table for minimum fluid overload on inclusion and goal for fluid removal
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 (slides Danish) (slides English)
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 furosemide (in Danish)
c) Receipt of trial medication
11) Laboratory tests
Not relevant for GODIF
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
b) Documentation for reporting of SAE/SAR/SUSAR (site specific). Template for reporting SAE/SAR.
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