Spring Intro 2023

24/03/2023

Content of a CTAin EU - Part II

National and Patient Level Documentation • Patient materials. Informed consent, patient information leaflet

• Compensation arrangements • Recruitment arrangements • Investigators and facilities suitability

• Damage compensation • Data protection rules

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Conclusion in Part I and Part II

• A weighted national decision - the sponsor is notified via CTIS • The clinical trial is granted an approval, conditional approval or rejection • Also, authorisation to extend the clinical trial to additional Member States or to make significant changes to an ongoing clinical trial already granted

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