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Protocol - 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

Individual Case Report Form Eudravigilance - Template

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

Risk Assessment Plan - Template

Study Files – SOP 1.6.a

Tilleggsavtale med forskningsstøtte - Template

Preparing Written Information and Consent Form - SOP 1.3.a

TMF Index Divider Multicenter Trial - Template

Vurdering av monitoreringsbehov kliniske studier - Templat

International Trials - WI 1.2.d

Data Management - SOP 1.12.b

Ongoing Trial Reports and Notifications - SOP 1.9.b

CV for Investigators - Template

Trial Master File (TMF) Table of Content Muliticenter Trial - Template

Roles and responsibilities in Clinical Trials - SOP

Query List - Template

IMP Handling Checklist - Template

Database Relock Form - Template

First in Human Early Phase Clinical Trials - WI 1.10.c

IMP Accountability Form with Kit or ID-Number - Template

Identification & Enrollment Log - Template

Protocol Deviation Notification and Tracking Form - Template

Clinical Investigations with Medical Device - SOP 2.1

Sjekkliste for internkontroll - Mal

Signature Log - Template