Francesca Spera -

The transition of clinical trial applications from the Directive 2001/20/EC (CTD) to the Regulation EU No 536/2014 (CTR), facilitated by the Clinical Trials Information System (CTIS), is designed to streamline the application process, enhance transparency, and improve collaboration among Member States and Sponsors.

To successfully transition a clinical trial to the CTR, the study must already have authorization under the CTD, with all relevant documentation previously approved by the Member State. The European Commission’s EudraLex Vol. 10 provides comprehensive guidance on the documentation required for Parts I and II of the application. Part I documentation includes the latest authorized versions of the harmonized protocol, Investigator’s Brochure, GMP documents, Investigational Medicinal Product Dossier and documents related to non-investigational medicinal products (if applicable). Part II necessitates the submission of the most up-to-date approved versions of the patient information sheet and informed consent form, accompanied by the positive opinion of the Ethics Committee.

Following a successful transition, any documents not included in the initial CTIS submission must be provided with consequent substantial amendments, ensuring that all parts of the trial dossier are complete and up to date.

The transition process to CTIS exempts Sponsors from evaluation fees for transitioning studies. However, subsequent substantial amendments will incur relevant fees.

RPN will provide any further update and is available to provide full support for clinical trials submitted through CTIS.

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