coach trial documents

Table of Content (1 through 16) (download)

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  • Instructions

  • Pocket cards (in Danish)

  • Educational materials

1) Protocol and trial synopsis

a) Approved protocol

b) Approved amendments (no amendments at present)

c) Trial synopsis

2) eCRF (for instruction, please see 9.a.iv.)

3) Trial participants

a) Delegation- and signature-log (in Danish)

b) Training log

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

4) Approvals and correspondence

a) The Danish Medicine Agency (in Danish)

b) EudraCT

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

d) The Danish Data Protection Agency (Datatilsynet in Danish) [Not avaliable online]

e) National and local approvals (site specific)

f) Annual Safety Report

5) Collaboration agreement

a) Collaboration agreement between Sponsor and site (template)

b) Approval from head of department (template)(in Danish click here)

c) Other relevant contracts (site specific)

6) Financial affairs

a) Case money (none)

b) Patient insurances (not needed for the COACH-trial)

7) Information to participants

a) Trial information to patients and relatives in Danish (templates) (in English click here)

b) Consent form in Danish (in English click here)

8) Co-enrolment and substudies

a) Co-enrolment Form (with access to Co-enrolment List)

b) Quality criteria for substudies

c) Substudy proposal form (template)

9) Trial documents

a) Trial instructions

i) Eligibility (in Danish)

ii) Screening and randomisation

iii) Trial medication (in Danish), co-interventions (in Danish) and concomitant interventions (in Danish)

iv) eCRF


b) Pocket cards, documents for a notice board in the department

i) Trial medication for notice board (in Danish)

ii) Inclusion and exclusion criteria for notice board (in Danish)

iii) Trial synopsis for notice board

iv) Pocket cards (in Danish)

v) Leaflet for clinicians/nurses (in Danish læger/plejepersonale)

vi) Sign for bed

vii) Identification log (in Danish click here)

c) Educational material (power point presentations)

i) Initiation (for nurses clik here)

ii) Screening and randomisation

iii) Trial medication dispensing

iv) Data entry

v) Withdrawal

vi) SAR/SUSAR and un-blinding

vii) Information for nurses (in Danish)

10) Trial Medication

a) Labels

b) Summary of product characteristics (in Danish)

c) Drug disposal form

d) Receipt of trial medication

e) Instruction for temperature logger

11) Laboratory tests (not applicable in the COACH-trial)

12) Primary data source (in Danish)

13) Communication

a) Contact details – Steering Committee

b) Contact details – participating countries

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) Investigator meeting

14) Serious adverse reactions ans suspected unexpected serious adverse reactions

a) SAR/SUSAR report form

b) Documentation for reporting of SAR/SUSAR (site specific)

15) GCP unit

a) Contacts (monitors/GCP units) (site specific) (in Danish)

b) Monitoring visits (template) (in Danish)

c) Monitoring reports (site specific)

d) Monitoring plan (in Danish click here)

e) Approval of trial initiation (site specific)

f) Correspondence with the monitor (e.g. GCP-unit) (site specific)

16) Trial completion

17) Appendices