Site Master File
Table of Content (1 through 12)
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1) Protocol and trial synopsis
b) Approved amendments
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) 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 forms to trial guardian, relatives, patient and data collection (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, screening and randomisation (Danish)
iii) SAE
iv) SOP for escape procedures (Danish)
v) Instructions for obtaining consent (Danish)
b) Pocket cards, documents for a notice board in the department
i) Inclusion criteria for notice board
ii) Trial synopsis for notice board
iii) Pocket cards (Danish)
iv) Leaflet for clinical staff (Danish)
v) Sign for bed (template)
c) Educational material (power point presentations)
i) Initiation for investigators (Danish)
d) Patient folder
i) Frontpage
ii) Content
iii) Standardnotater (template)
iv) Contact information – local (template)
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)