Module 5 Presentations

05/07/2024

Category 1: Phase I, Bioequivalence, Bioavailability and biosimilar trials Category 2: Phase II and III trials Category 3: Phase IV and LICT

CTR : New Transparency Rules

Source: CTIS transparency rules: quick guide for users (EMA) here

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

29

Transparency: References and guidance

• EMA website • Revised CTIS Transparency Rules (05Oct2023) ( here )

• ACT EU / CTR implementation page • Revised CTIS transparency rules & historical trials: quick guide for users Version 1.5 ( here ) • Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) Version 2 ( here ) • Annex I - Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) Version 1.1 ( here ) • Q&A on the protection of commercially confidential information and personal data while using CTIS Version 2 ( here )

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

30