University of Oslo
The University Director
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Appendix 4.13 to Procedure description 4
1 of 3
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15 February 2012
Project management clinical trial of medicinal devices
CHECKLIST FOR ARCHIVING OF PROJECT DOCUMENTATION
BEFORE TRIAL INITIATION
1.1
Advance internal submission of
the project
See Procedure description 4 point 4.5 and Procedure
description 2, Appendix 2.1 , Project planning form
1.2
Insurance of trial subjects
See Procedure description 4 point 4.4
1.3
Documentation of
investigational medicinal
device
Trial protocol
Reference values
Documentation laboratories
and equipment
Labelling of investigational
medicinal device
Instructions for handling
investigational medicinal
device
Investigational medicinal
advice accountability
For example information from the producer
Case report form
(CRF)
Information to trial subjects
Informed consent form
Or electronic system
1.4
1.5
1.6
1.7
1.8
1.9
1.10
1.11
1.12
1.13
Qualifications of Principal
Investigator and coinvestigators
Application to REK
1.14
Correspondence with REK
1.15
1.16
1.17
Approval from REK
List of REK members
Application to Norwegian
Ministry of Health and Care
Services.
1.18
Correspondence with
Norwegian Ministry of Health
and Care Services.
1.19
Approval from
Norwegian Ministry of Health
and Care Services.
Approval from the Norwegian
Biotechnology Advisory Board
(if relevant)
Contracts with business
partners
Contracts with subcontractors
1.20
1.21
1.22
Final version, signed and dated
For analyses and measures
Measures of significance for the trial result
See Procedure description 4 Appendix 4.11 Investigational
medicinal devices accountability form
Version sent to REK for approval
Final version, approved by REK
CV or the equivalent.
Copy of full application with appendices or reference to
appendices
Including any appendices
At the time of REK's assessment
Copy of full application with appendices or reference to
appendices
Including any appendices
In the case of research pursuant to the Norwegian
Biotechnology Act
Final version, signed and dated
Final version, signed and dated
UiO's quality assurance system for medical and health research
1
University of Oslo
The University Director
Page:
Version:
Valid from:
Appendix 4.13 to Procedure description 4
2 of 3
1
15 February 2012
Project management clinical trial of medicinal devices
CHECKLIST FOR ARCHIVING OF PROJECT DOCUMENTATION
Form for subject identity list
and list of trial subjects
Randomisation list
See Procedure description 6 Appendix 6.3. Subject identity
list and list of trial subjects
N.B. in blinded trial design this must not be openly
accessible to project team members, including the Project
Manager
1.25
Project-specific procedure for
blinding the investigational
medicinal device
For blinded clinical trial design
1.26
Research Biobank form
1.27
Form for handling and storage
of data
If relevant
See Procedure description 5 and Appendix 5.1. Checklist
for Research Biobank
See Procedure description 6 and Appendix 6.1 Checklist for
handling and storage of data in the individual project
1.28
Appendix 3.1 Form for
documentation of Principal
Investigator and trial site
See Appendix 4.1 Form for documentation of Principal
Investigator and trial site
1.29
Initiation meeting form
See Appendix 4.4 Initiation meeting form
1.30
Form for Principal
Investigator's delegation of
tasks
See Appendix 4.2 Form for Principal Investigator's
delegation of tasks
1.23
1.24
DURING THE PROJECT
2.1
2.2
2.3
2.4
2.5
2.6
Updated documentation on the
investigational medicinal device
Signed consents
Completed case report form(s)
2.7
Completed subject identity list
Amendments to trial protocol
Amended information to trial
subjects
Amended informed consent
form
Amended applications to REK
2.8
Correspondence with REK
2.9
Approval of amendments from
REC
Applications for amendments to
Norwegian Directorate of
Health
Correspondence with
Norwegian Directorate of
Health
Approval of amendments from
Norwegian Directorate of
Health
2.10
2.11
2.12
Dated and signed by trial subjects
Or reference to electronic system. see Procedure
description 6
To be kept separately
Final version, signed and dated
Version sent to REK for approval
Final version, approved by REK
Copy of application with appendices or reference to
appendices
Including any appendices or reference to appendices
Copy of application with appendix/ices or reference to
appendix/ices
Including any appendices or reference to appendices
UiO's quality assurance system for medical and health research
2
University of Oslo
The University Director
Page:
Version:
Valid from:
Appendix 4.13 to Procedure description 4
3 of 3
1
15 February 2012
Project management clinical trial of medicinal devices
CHECKLIST FOR ARCHIVING OF PROJECT DOCUMENTATION
2.13
2.14
2.15
2.16
2.17
2.18
Updated reference values
Updated documentation
laboratories and equipment
Updated investigational
medicinal device accountability
Contracts with subcontractors
Source documentation/raw
data
Serious adverse event reports
Updated or new
See Procedure description 6
See Appendix 4.11 Form for reporting and classification of
serious adverse events to the Sponsor and
4.12 Form for reporting serious adverse device effects to
the Directorate of Health.
2.19
2.20
2.21
Monitoring reports
Completed case report forms
(CRFs)
Completed form for subject
identity list and list of trial
subjects
After completed trial
3.1
3.2
3.3
3.4
Completed case report form(s)
(CRPs)
Or reference to electronic
system
Signed consents
3.5
Notification of close-out to REK
Notification of close-out to
Norwegian Directorate of Health
Source documents/raw data
3.6
Complete subject identity list
3.7
3.8
39
3.10
Statistical calculations
Final report
Publication
Research Biobank form (if
relevant)
3.11
Form for handling and storage
of data
3.12
3.14
Serious adverse event reports
Closed out investigational
medicinal product accountability
Project completion
3.15
Complete set; See Procedure description 6
Complete set
See Procedure description 6
Complete set
See Procedure description 6
To be kept separately
See Procedure description 6 and Procedure description 4,
point 4.17
Completed
see Appendix 5.1 Checklist for research biobank
Completed
See Procedure description 6 and Appendix 6.1 Checklist
for handling and storage of data in the individual project
See Appendix 4.9 Project completion form
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