EMPRESS – log for new documents and/or new updated versions for the Site Master File

Print version of log of changes:

DateDescription
05.08.2024Uploaded documents to Chapter 4: Authority Approvals;
a) EMPRESS Ethics Committee assessment rapport for Part II of the substantial modification application 1
05.08.2024Uploaded documents to Chapter 7: Information to Participants and section 8: Co-Enrolment And Sub-Studies;
Chapter 7:
a) Trial information to patient, relatives and trial guardian in Danish
b) Consent form to patient, relatives and trial guardian in Danish
c) The rights of the patient in clinical research
Chapter 8:
a) Co-enrolment Form and Co-enrolment list in English
b) Quality criteria for sub-studies in English
c) Sub-study proposal form in English
26.07.2024Uploaded documents to Chapter 5: Collaboration Agreement and Chapter 6: Financial Affairs;
Chapter 5:
a) Collaboration agreement between Sponsor and site for Denmark
b) Approval from head of department for Denmark
Chapter 6:
a) Case money in both Danish and English
10.07.2024Uploaded documents to Chapter 4: Approvals and Correspondence;
a) EMPRESS Medicines Agency approval for Denmark
b) EMPRESS Ethics Committee assessment rapport for Part II of the initial application for Denmark
05.07.2024Uploaded Danish and English versions of the documents to Chapter 3: Trial Participants;
a) Delegation- and signature log
b) Training log
c) Trial personnel CV
02.07.2024Uploaded Danish and English versions of the documents to Chapter 1: Protocol and trial synopsis;
a) EMPRESS protocol
b) EMPRESS trial synopsis