Article | March 15, 2024

CTR In Focus: Handling Substantial Modifications Under The CTR

By Xandra Neuberger, Associate Director Regulatory Affairs


The transition of ongoing clinical trials to the Clinical Trials Information System (CTIS) in accordance with the Clinical Trials Regulation (CTR) has raised several questions among sponsors regarding compliance requirements. Particularly, there's ambiguity regarding when the dossier must be fully CTR compliant. Contrary to common misconceptions, sponsors aren't obligated to submit a substantial modification solely for the purpose of achieving CTR compliance post-transition. According to the commission's transition guidance, the first substantial modification under CTR triggers the obligation to update the entire dossier in line with CTR standards.

In this article, we delve into the nuances of transitioning clinical trials to CTIS and complying with CTR requirements. We explore the strategic considerations surrounding the timing and necessity of updating dossiers, especially in cases where no substantial modification is planned. Additionally, learn important points regarding substantial modifications, including the impact on ongoing reviews and system functionalities affecting submission processes.

Understanding these complexities is essential for sponsors to effectively navigate the transition process and ensure compliance with CTR standards while optimizing regulatory life-cycle management of clinical trials.

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