COVID STEROID 2 Site Master File

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Trial Master File

Table of Content (1 through 17)

Please see LOG for latest uploads of new documents and/or new versions of documents in Trial Master File

1) Protocol and trial synopsis

a) Approved protocol

b) Approved amendments

c) Trial synopsis

d) Front page to be signed by Primary Investigator

2) eCRF

Not required in Site Master File

For instruction, please see 9.a.iv.

3) Trial participants

a) Delegation- and signature-log

b) Training log

c) Curriculum Vitae for all personnel (template English and Danish)

4) Approvals and correspondence

a) The Danish Medicine Agency

b) EudraCT

c) The Committees on Health Research Ethics (in Danish). Approved amendments.

d) The Capital Region Knowledge Center for Data Compliance: Approval to commence trial in the Capital Region of Denmark

e) National and local approvals (site specific)

f) Annual Safety Report

5) Collaboration agreement

a) Clinical Trial Agreement between Sponsor and site (template) for Danish sites and Clinical Trial Agreement between Sponsor and National Coordinator for international sites (template). Preliminary approval to start the trial in Denmark from the legal authorities.

b) Approval from head of department (template)

c) Collaboration Agreement between Sponsor and Primary Investigator (template)

d) 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 patient in Danish and in English

b) Consent form to first trial guardian, second trial guardian, relatives and patients in Danish and in English

c) Continued data registration form (for patients withdrawn from the trial due to no consent) in Danish and in English

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

c) Substudy proposal form

9) Trial documents

a) Trial instructions

i) Eligibility

ii) Screening and randomisation

iii) Trial medicationco-interventions and concomitant interventions

iv) eCRF

v) SAE, SUSAR and unblinding (see 9c,vi)

vi) Daily operation of trial

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

v) Leaflet for clinical staff in Danish or English

vi) Sign for bed

c) Educational material (power point presentations)

i) Initiation for investigators (slides or video)

ii) Screening and randomisation

iv) Data entry

v) Withdrawal

vi) SAE/SUSAR and unblinding

d) Procedures

i) Procedures approved by Sponsor

ii) Procedure for randomisation during system failure and screening formula for randomisation during system failure

iii) Procedure for obtaining consent in Denmark

10) Trial Medication

a) Labels

b) Summary of Product Characteristics for Saline and Dexamethasone (in Danish)

c) Trial medication log in Danish or English

d) Video instructions and guide to trial medication preparation in Danish or English, including guide to trial medication if the patient has already received dexamethasone on the day of screening

11) Laboratory tests

Not applicable in the COVID STEROID trial

12) Primary data source (template) and primary 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

a) SAE/SUSAR report form

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

16) Trial completion

17) Appendices

a) EQ-5D-5L questionnaires for 180-day follow-up