Siste 50 endringer

Simplified Development Safety Update Report - Template

Safety Reporting - SOP 1.4.b

Safety Planning - SOP 1.4.a

Checklist Initiation of Clinical Trial - Sponsor - Template

Sponsor Trial Oversight - SOP 1.5.a

Obtaining Informed Consent - SOP 1.3.b

Preparing Written Information and Consent Form - SOP 1.3.a

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

Quality and Risk Management - SOP 1.10.a

Ongoing Trial Reports and Notifications - SOP 1.9.b

Modifications after Trial Start – SOP 1.9.c

International Trials - WI 1.5.c

Protocol - SOP 1.2.a

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

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

Individual Case Safety Report Form EudraVigilance - Template

Monitoring - SOP 1.14.a

Data Management - SOP 1.12.b

Agreements - SOP 1.13.a

Advanced Therapies – SOP 1.11.a

Training and Qualification – SOP 1.7.a

Study Files – SOP 1.6.a

Trial Initiation Report - Template

Monitoring Report - Template

Training Log - Template

Safety Information Review Log – Template

Risk Assessment - Template

Query List - Template

Protocol Version Tracking Log - Template

Protocol Deviation Notification and Tracking Form - Template

Protocol Deviation Handling Plan - Template

Protocol Deviation Handling - SOP 1.10.b

Informed Consent Document Version Tracking Log - Template

Completion, Reporting and Archiving – SOP 1.6.b

Close-out Monitoring Report - Template

Checklist Conduct of Clinical Trial - Sponsor - Template

EudraVigilance Registration and SUSAR Reporting - WI 1.4.c

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

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

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

Protocol Synopsis - Template

Principal Investigator Trial Oversight - SOP 1.5.b

Definitions - SOP 1.1.b

Monitoring for monitors - SOP 1.15.a

Co-Monitoring - SOP 1.15.b

*** ICH-GCP R3 compliance ***

Application Process and Approvals - SOP 1.9.a

Power of Attorney - Template

TMF/ISF Table of Content Single Center Trial - Template

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