Modified: May 20, 2020 at 1:51 pm

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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

a) Approved protocol 

b) Approved amendments

c) 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

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 (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) – Preliminary approval to start the trial from the legal authorities

b) Approval from head of department (template)

c) Other relevant contracts (site specific)

 

6) Financial affairs

a) Case money (none)

b) 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)

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

c) Further data registration form for relatives and patients (for patients withdrawn from the trial due to no consent)

d) The rights of the patient in clinical research

 

 

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

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

v) Leaflet for clinical staff

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

vi) SAE/SUSAR and unblinding

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

b) Summary of product characteristics for Saline and Hydrocortisone (in Danish)

c) Trial Medication log

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 – Mangament 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 questionnaire for 1-year follow-up and by proxy