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1) Quality management
1.1) Approval from department
1.2) Trial specific guidelines
- 1.2.1 Short guideline to staff (folder) (danish) (english)
- 1.2.2 Operational guideline, including local procedure about consent
- 1.2.3 Guideline for data entry
- 1.2.4 Guideline for obtaining 180-day consent
- 1.2.5 Additional documents to patient folder
1.3 Template for protocol deviations (note to file)
1.4 Approved documents, forms etc.
1.5 Other
- 1.5.1 Co-enrolment (list and forms)
- 1.5.2 Quarterly quality check
- 1.5.3 Training certificate R3
- 1.5.4 GAP-analysis for site-investigator
2) Approval from authorities
2.1 Report for the Application Evaluation Decision
- 2.1.1 Initial application
- 2.1.2 Substantial and non-substantial modifications
2.2 Documentation for reporting to sponsor of serious breach, unexpected events and urgent safety measures
2.3 Other
3) Data legislation
3.1 Documentation for registration in the institutions internal register
3.2 Data processing agreements
3.3 Other
4) Protocol, substantial and non-substantial modifications
4.1 Protocol
4.2 Protocol change log
4.3 Protcol adherence (note to file)
4.4 Other
- 4.4.1 National appendix
- 4.4.2 Substudy proposals
5) Trial participants
5.1 Screeninglog of potential trial participants
5.2 Identification log of trial participants
5.3 Information sheet
5.4 Consent forms
5.5 Signed consent forms
5.6 Participant rights
5.7 Recruitment letter
5.8 Participant cards
5.9 Diaries
5.10 Standard letter to trial participants
5.11 Questionnaires
- 5.11.1 EQ-5D-5L
5.12 Other
6) Agreements on collaboration
6.1 Sponsor and investigator (clinical trial agreement)
6.2 Investigator and local pharmacy
6.3 Investigator and local laboratory
6.4 Investigator and local departments
6.5 Other
- 6.5.1 Co-authorship
7) Electronic case report form (eCRF)
7.1 Copy of all eCRF-versions
7.2 Guideline in the use of the eCRF
7.3 Completed eCRFs
7.4 Other
- 7.4.1 Site user list
8) Electronic systems aside from eCRF
8.1 Documentation for validation of electronic systems
8.2 Documentation for validation of data transmission between local electronic systems
8.3 Other
9) Source data
9.1 Source data lists
9.2 Source data/source documents
9.3 Other
10) Project staff
10.1 List of investigators delegation of tasks
10.2 Curriculum Vitae and GCP course certificates
10.3 Documentation of training
10.4 Signature list
10.5 Other
- 10.5.1 Educational material
11) Trial medication
11.1 Summary of product characteristics
11.2 Copy of labels
11.3 Receipts of conveyance
11.4 Documentation for acceptance testing
11.5 Code envelopes
11.6 Procedure for code violation
11.7 Documentation for eventual unblinding
11.8 Documentation for treatment allocation
11.9 Overall trial medication report
11.10 Individual trial medication report
11.11 Documentation for destruction of trial medication
11.12 Temperature log for trial medication
11.13 Other
14) Correspondance
14.1 Relevant correspondance (arranged by date)
14.2 Relevant minutes
14.3 News letters
14.4 Other
15) Registration of serious events and reactions
15.1 SAE-SUSAR form
15.2 Completed SAE-SUSAR forms
15.3 Documentation for reporting SAE from investigator to sponsor
15.4 SAE log excepted from “immediately reporting”
15.5 Annual safety reports, including SUSAR list
15.6 Safety updates from sponsor to investigator
15.7 Other
16) Financial affairs
16.1 Documentation of financial agreements
- 16.1.1 Case money
16.2 Documentation of insurance cover
16.3 Other
17) Monitoring
17.1 Initiation report
17.2 Approval for trial start
17.3 Reports from on-site monitoring
17.4 Final monitoring report
17.5 Other
18) Data processing
18.1 Other
19) Trial completion
19.1 Documentation for completion of trial in CTIS
19.2 Information to collaborators about trial completion
19.3 Summary of results
19.4 Lay person summary of results
19.5 Other
1) Protocol and trial synopsis
c) Trial synopsis (Danish) (English)
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
b) The Capital Region Knowledge Center for Data Compliance (Legal department)
c) National and local approvals (site specific)
d) Annual Safety Report
5) Collaboration agreement
a) Collaboration agreement between Sponsor and site (Denmark)
b) Approval from head of department (Denmark)
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 patient, relatives and trial guardian (Danish) (English).
b) Consent form to patient, relatives and trial guardian (Danish) (English).
c) The rights of the patient in clinical research (Danish)
8) Co-enrolment and sub-studies
a) Co-enrolment Form (English) (with access to Co-enrolment list)
b) Quality criteria for sub-studies (English)
c) Sub-study proposal form (English)
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)