University of Oslo
The University Director
Page:
Version:
Valid from:
Appendix 3.13 to Procedure description 3
1 of 3
1
15 February 2012
Project management clinical trial of medicinal products
CHECKLIST FOR ARCHIVING OF PROJECT DOCUMENTATION
BEFORE TRIAL INITIATION
1.1
Advance internal submission of
the project
See Procedure description 3 point 4.5 and Procedure
description 2, Appendix 2.1 , Project planning form
1.2
Insurance of trial subjects
See Procedure description 3 point 4.4
1.3
Documentation of quality,
safety and efficacy of
investigational medicinal
product
Trial protocol
Reference values
Documentation laboratories
and equipment
Labelling of investigational
medicinal product
Instructions for handling
investigational medicinal
product
Investigational medicinal
product accountability
For example Investigator's Brochure or approved summary
of product characeristics (SPC)
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 REC
1.14
Correspondence with REC
1.15
1.16
1.17
Approval from REC
List of REC members
Application to NoMA
1.18
1.19
1.20
Correspondence with NoMA
Approval from NoMA
Approval from the Norwegian
Biotechnology Advisory Board
(if relevant)
Contracts with business
partners
Contracts with subcontractors
Form for subject identity list
and list of trial subjects
Randomisation list
1.21
1.22
1.23
1.24
Final version, signed and dated
For analyses and measures
Measures of significance for the trial result
See Procedure description 3 Appendix 3.11 Investigational
medicinal product accountability form
Version sent to REC for approval
Final version, approved by REC
CV or the equivalent.
Copy of full application with appendices or reference to
appendices
Including any appendices
At the time of REC'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
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
UiO's quality assurance system for medical and health research
1
University of Oslo
The University Director
Page:
Version:
Valid from:
Appendix 3.13 to Procedure description 3
2 of 3
1
15 February 2012
Project management clinical trial of medicinal products
CHECKLIST FOR ARCHIVING OF PROJECT DOCUMENTATION
1.25
Project-specific procedure for
blinding the investigational
medicinal product
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 3.1 Form for documentation of Principal
Investigator and trial site
1.29
Initiation meeting form
See Appendix 3.4 Initiation meeting form
1.30
Form for Principal
Investigator's delegation of
tasks
See Appendix 3.2 Form for Principal Investigator's
delegation of tasks
DURING THE PROJECT
2.1
2.2
2.3
2.4
2.5
2.6
Updated documentation quality,
safety and efficacy of
investigational medicinal
product
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 REC
2.8
Correspondence with REC
2.9
Approval of amendments from
REC
Applications for amendments to
NoMA
Correspondence with NoMA
Approval of amendments from
NoMA
Updated reference values
Updated documentation
laboratories and equipment
Updated investigational
medicinal product
accountability
Contracts with subcontractors
2.10
2.11
2.12
2.13
2.14
2.15
2.16
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 REC for approval
Final version, approved by REC
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
Updated or new
UiO's quality assurance system for medical and health research
2
University of Oslo
The University Director
Page:
Version:
Valid from:
Appendix 3.13 to Procedure description 3
3 of 3
1
15 February 2012
Project management clinical trial of medicinal products
CHECKLIST FOR ARCHIVING OF PROJECT DOCUMENTATION
2.17
2.18
2.19
2.20
2.21
Source documentation/raw
data
Serious adverse event reports
See Procedure description 6
See Appendix 3.12
Form for reporting and
classifying serious adverse events / adverse reactions
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 REC
Notification of close-out to
NoMA
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
Serious adverse event reports
3.14
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 3,
point 4.18
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 2.6 Form for reporting serious adverse
events
See Appendix 3.10 Project completion form
UiO's quality assurance system for medical and health research
3