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Modifications after Trial Start – SOP 1.9.c

DSUR - Template

Individual Case Report Form Eudravigilance - Template

CTIS Compliance Norwegian Requirements on Data Protection - Template

CTIS Statement on compliance Regulation (EU) 2016/679 - Template

CTIS Financial and Other Arrangements - Template

CTIS CV for Investigators - Template

CTIS Cover letter initial application - Template

CTIS Compliance with applicable rules for biological samples - Template

CTIS Recruitment and Informed consent procedure - Template

CTIS Site Suitability - Template

CTIS Modification description - Template

Screening Log - Template

CTIS Declaration of Interest - Template

Simplified Development Safety Update Report - Template

CTIS RFI Response List of Changes to the Application - template

CTIS Cover letter Substantial Modification - template

Protocol - Template

Statistics - SOP 1.2.c

Data Monitoring Committee Charter - Template

Statistical Analysis Plan - Template

Monitoring Report CIO - Appendix 12

Initiation Report CIO - Appendix 11

Table of Content ISF/TMF - Single Centre Study Clinical Intervention and Obsevational Studies - Appendix 10

Table of Content TMF - Multicentre Study - Appendix 9

Table of Content ISF - Appendix 8

Subject ID-Log - Appendix 5

Screening Log - Appendix 4

Accountability of Intervention - Appendix 3

Delegation Log - Appendix 2

Close-Out Report CIO - Appendix 13

Investigational Medicinal Product (IMP) at Trial Start - SOP 1.8.a

Reference Safety Information review Log – Template

Application Process, Approvals - SOP 1.9.a

Safety Reporting - SOP 1.4.b

Data Processing Agreement for Monitoring Services - Template

Quality and Risk Management - SOP 1.10.a

Monitoring Report Biobank - Template

Co-Monitoring - SOP 1.16.b

Monitoring for monitors - SOP 1.16.a

Risk Assessment - Template

Power of Attorney - Template

Contact Information Study Team - Template

Prescreening Log - Template

Legislation and Guidelines - 2.3

Agreement for Transfer of Clinical Trial Tasks in Decentralised Trials - Template

Transfer of Clinical Trial Tasks to other Hospitals (decentralised trials) - SOP 1.13.b

Study Files – SOP 1.6.a

Tilleggsavtale med forskningsstøtte - Template

Preparing Written Information and Consent Form - SOP 1.3.a