Siste 50 endringer

*** ICH-GCP R3 compliance ***

Definitions - SOP 1.1.b

Application Process and Approvals - SOP 1.9.a

Power of Attorney - Template

Protocol Version Tracking Log - Template

Investigator’s Site File (ISF) Table of Content - Template

TMF/ISF Table of Content Single Center Trial - Template

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

Monitoring Report - Template

Principal Investigator (PI) Site Risk Evaluation Checklist Prior to Study Initiation - Template

Data Monitoring Committee Charter - Template

Co-Monitoring - SOP 1.16.b

Monitoring for monitors - SOP 1.16.a

Monitoring - SOP 1.14.a

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

Agreements, Information Routines and Delegation of Tasks - SOP 1.13.a

Data Management - SOP 1.12.b

Case Report Form and Patient Reported Outcome - SOP 1.12.a

Study Files – SOP 1.6.a

Advanced Therapies – SOP 1.11.a

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

Protocol Deviation Handling - SOP 1.10.b

Quality and Risk Management - SOP 1.10.a

Ongoing Trial Reports and Notifications - SOP 1.9.b

Investigational Medicinal Product (IMP) Management at Clinical Trial Completion - SOP 1.8.c

Investigational Medicinal Product (IMP) Management During Trial - SOP 1.8.b

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

Training and Qualification – SOP 1.7.a

Completion, Reporting and Archiving – SOP 1.6.b

Principal Investigator Trial Oversight - SOP 1.5.b

EudraVigilance Registration and SUSAR Reporting - WI 1.4.c

Safety Reporting - SOP 1.4.b

Safety Planning - SOP 1.4.a

Preparing Written Information and Consent Form - SOP 1.3.a

Obtaining Informed Consent - SOP 1.3.b

International Trials - WI 1.2.c

Statistics - SOP 1.2.b

Protocol - SOP 1.2.a

Checklist Completion of Clinical Trial - Sponsor - Template

Checklist Initiation of Clinical Trial - Sponsor - Template

Checklist Conduct of Clinical Trial - Centre - Template

Protocol Deviation Log Single Center Study - Template

Protocol Deviation Log Multicenter Study - Template

Labels for Archiving - Template

Database Unlock Form - Template

CTIS Cover letter initial application - Template

Risk Assessment - Template

Sponsor Trial Oversight - SOP 1.5.a

User Acceptance Testing (UAT) - Template

Green Light for Trial Site - Template