Site Master File
Table of Content (1 through 12)
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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 8.a.iii.)
3) Trial participants
a) Delegation- and signature-log (in Danish)
b) Training log (Danish)
4) Approvals and correspondence
a) The Committee on Health Research Ethics in the North Denmark Region (in Danish)
b) Local approvals (site specific)
c) Annual Safety Report
5) Collaboration agreement
a) Collaboration agreement between Sponsor and site
b) Approval from head of department (in Danish)
c) Other relevant contracts (site specific)
6) Information to participants
a) Trial information to trial guardian, relatives and patient (in Danish).
b) Consent form to trial guardian, relatives and patient (in Danish).
c) The rights of the patient in clinical research (in Danish)
7) Co-enrolment and sub-studies
a) Co-enrolment Form (with access to co-enrolment list)
b) Sub-study proposal form
8) Trial documents
a) Trial instructions
i) Eligibility (Danish)
ii) Screening and randomisation
iii) Instructions for the eCRF
iv) SAE
v) SOP for escape procedures (Danish)
vi) Instructions for obtaining consent (Danish)
b) Pocket cards, documents for a notice board in the department
i) Inclusion and exclusion criteria for notice board
ii) Trial synopsis for notice board
iii) Pocket cards (Danish)
iv) Leaflet for clinical staff (Danish)
v) Sign for bed
c) Educational material (power point presentations)
i) Initiation for investigators (slides) and for primary trial personnel (slides)
9) 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)