Countdown to January 2025: Transitioning to CTIS under the CTR

Introduction

As the 31 January 2025 deadline approaches, the Clinical Trials Regulation (CTR) and the Clinical Trials Information System (CTIS) are becoming critical topics for sponsors and stakeholders in the EU clinical trial landscape. The end of the three-year transition period signifies a pivotal shift towards a more streamlined and unified approach to clinical trial applications and supervision.

Why is this Transition Important?

The transition to CTIS under the CTR is not just a regulatory change — it's a critical shift that requires immediate attention. Failure to transition your ongoing studies by the 31 January 2025 deadline can have severe repercussions:

• Trial Suspension: Studies that do not transition will be suspended, halting any ongoing research and patient involvement.
• Regulatory Non-Compliance: Non-compliance with the CTR will result in significant regulatory complications, including potential fines and legal actions.
• Data Integrity Risks: Incomplete transitions can lead to data integrity issues, impacting the reliability and validity of your study results.

Ensure your trials are compliant with the new regulations to avoid these drastic consequences.

Key Steps for a Smooth Transition

To ensure a smooth transition to CTIS, sponsors should consider the following steps:

1. Familiarize with CTIS Functionality: Understand the functionalities of CTIS, including application submission, role management, and data reporting.
2. Engage in Training: Participate in training sessions and webinars offered by the European Medicines Agency (EMA) to get hands-on experience with CTIS.
3. Update Internal Processes: Align your internal processes and systems to comply with the new requirements under the CTR.
4. Seek Expert Guidance: Consult with a CTIS Sponsor Master Trainer and Study Start-Up Consultant, such as myself, to ensure your transition is seamless and compliant.

Call to Action

The clock is ticking as we approach the final phase of transitioning to CTIS under the CTR. To ensure a smooth transition, make sure your trial transition submissions are completed by 16 October 2024. This deadline is crucial to avoid any disruption in your clinical trial activities. Trials that are not transitioned by this date will not be allowed to continue under the old directive, which could result in significant delays and regulatory complications.

Feel free to share your experiences or ask questions about transitioning to CTIS in the comments below. Additionally, if you need personalized guidance, reach out to me as a CTIS Sponsor Master Trainer and Study Start-Up Consultant to ensure a seamless transition.

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