Module 5 Presentations

05/07/2024

Clinical Trial Information System

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

15

CTR – Single entry point for submissions ( CTIS Clinical Trial Information System)

Prepare CT application

Finalize CTA submissions and upload documents (Part I / Part II) in CTIS (electronic only)

Submit via CTIS

Country Decision(s)

Start clinical trial

Select investigator sites required in CTA submission

Site contract negotiation and execution

Account for country confirmation, investigators’ selection and essential documents collection in the preparation timelines (interaction with Clinical Operations / CROs)

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

16