Short cut to:
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Instructions
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Pocket cards (in Danish)
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Initiation video for investigators, initation video for primary trial personnel and a video for trial medication preparation
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Video instructions for trial medication preparation
Trial 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 to be signed by Primary Investigator
2) eCRF (for instruction, please see 9.a.iv.)
3) Trial participants
a) Delegation- and signature-log
b) Training log (clean version) and training log signed by Sponsor for primary investigators and primary trial personnel
c) Curriculum Vitae for all personnel (template)
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) – Preliminary Approval
e) National and local approvals (site specific)
f) Annual Safety Report
5) Collaboration agreement
a) Collaboration agreement between Sponsor and site (template) for Danish sites and Collaboration agreement between Sponsor and National Coordinator for international sites – Preliminary approval to start the trial in Denmark from the legal authorities
b) Approval from head of department (template)
c) Other relevant contracts (site specific)
6) Financial affairs (site specific)
a) Patient insurances (not needed for Danish hospitals)
7) Information to participants
a) Trial information to trial guardian, relatives and patients in Danish (templates) (in English click here: relatives and patients)
b) Consent form in Danish to first trial guardian, second trial guardian, relatives and patients (in English click here: relatives and patients)
c) Further data registration form for relatives and patients (for patients withdrawn from the trial due to no consent) (in English click here: relatives and patients)
d) The rights of the patient in clinical research in Danish
8) Co-enrolment and substudies
a) Co-enrolment Form (with access to Co-enrolment List)
b) Quality criteria for substudies
9) Trial documents
a) Trial instructions
i) Eligibility
ii) Screening and randomisation
iii) Trial medication, co-interventions and concomitant interventions
iv) eCRF
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 in Danish or English
vi) Sign for bed
c) Educational material (power point presentations)
i) Initiation for investigators (slides or video) and for primary trial personnel (slides or video)
ii) Screening and randomisation
iii) Trial medication dispensing (slides or video)
iv) Data entry
v) Withdrawal
d) Procedures
i) Approved procedures by sponsor
ii) How to randomise a patient if system failure occur? and screening formula for randomisation during system failure
iii) Procedure for obtaining consent
10) Trial Medication
a) Labels for infusion or bolus injection (in English click here)
b) Summary of Product Characteristics for Saline and Hydrocortisone (in Danish)
d) Video instructions and guide for trial medication preparation
11) Laboratory tests
Not applicable in the COVID STEROID trial
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) News letters
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/SUSAR (site specific)
15) GCP unit
a) Contacts (monitors/GCP units) (site specific)
b) Monitoring visits (template)
c) Monitoring reports (site specific)
d) Monitoring plan and data verification plan
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
h) Training from GCP to Primary Investigators