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Green Light for Trial Site - Template

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

Principal Investigator Trial Oversight - SOP 1.5.b

International Trials - WI 1.5.c

Safety Reporting - SOP 1.4.b

Safety Planning - SOP 1.4.a

Statistics - SOP 1.2.b

Protocol - SOP 1.2.a

Completion, Reporting and Archiving – SOP 1.6.b

Roles and Responsibilites in Medical Device studies - SOP

Roles and responsibilities in Clinical Trials - SOP

Clinical Investigations with Medical Device - SOP 2.1

Guideline for Clinical Interventional and Observational studies (CIO)

Sponsor Trial Oversight - SOP 1.5.a

Guidance safety report form - Appendix 10

Clinical Investigation Report - Appendix 14

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

Obtaining Informed Consent - SOP 1.3.b

Monitoring for monitors - SOP 1.15.a

Quality and Risk Management - SOP 1.10.a

Statistical Analysis Plan - Template

Source Data List - Template

IMP Accountability Form Common Stock Unnumbered - Template

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

Participant ID-Log - Appendix 5

Co-Monitoring - SOP 1.15.b

Monitoring - SOP 1.14.a

Agreements - SOP 1.13.a

EudraVigilance Registration and SUSAR Reporting - WI 1.4.c

Definitions - SOP 1.1.b

CTIS Compliance with applicable rules for biological samples - Template

Application Process and Approvals - SOP 1.9.a

CTIS Site Suitability - Template

CTIS RFI Response List of Changes to the Application - template

Simplified Development Safety Update Report - Template

Checklist Initiation of Clinical Trial - Sponsor - Template

Preparing Written Information and Consent Form - SOP 1.3.a

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

Ongoing Trial Reports and Notifications - SOP 1.9.b

Modifications after Trial Start – SOP 1.9.c

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

Individual Case Safety Report Form EudraVigilance - Template

Data Management - SOP 1.12.b

Advanced Therapies – SOP 1.11.a

Study Files – SOP 1.6.a

Trial Initiation Report - Template

Monitoring Report - Template

Training Log - Template