EMPRESS Site Master File

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

a) Approved protocol

b) Approved amendments

c) 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 (Danish) (English)

b) Training log (Danish) (English)

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

4) Approvals and correspondence

a) Clinical Trials Information System (CTIS) approval

b) EudraCT

c) The Committees on Health Research Ethics (Danish). 

d) The Capital Region Knowledge Center for Data Compliance (Legal department) (only in Danish)

e) National and local approvals (site specific)

f) 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Vii) Bedside worksheet (withdrawn/obsolete)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