How to Manage Clinical Trials Transitioned to the CTR?

Recommendation

5-7 November 2024
Hamburg, Germany

GMP meets Development
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

In order to help sponsors using the CTIS, the EMA has published a sponsor handbook. The EMA is continuously updating the CTIS Sponsor Handbook with further priority topics and a revised Version 3 has now been published.

Clinical Trials Information System (CTIS) - Sponsor Handbook (v. 3.00)

The Handbook is a compilation of key guidance, technical information, recommendations and references for getting ready for use of the CTIS. Amongst others, the following new sections have been added: 

• How to get a clinical trial application started in CTIS (section 4)
• How to create a transitional trial in CTIS (section 5.3)
• How to manage trials transitioned to the CTR in CTIS (section 5.4)

Only trials submitted under the CTD (EU Clinical Trials Directive) and likely to be ongoing beyond 31 January 2025 need to be transitioned if they meet these criteria:

• are interventional clinical trials in humans;
• involve at least one site in the EU/EEA where the trial is still ongoing;
• are not on hold;
• there are no substantial amendments ongoing in any Member State Concerned (MSC) under the Directive.

Sponsors need to ensure that all current approved documents under the CTD are available in electronic format in compliance with CTIS upload requirements (retrospective documents do not need to be submitted to CTIS). To transition a trial from EudraCT to CTIS, sponsors need to submit an initial CTA marked as a transitional trial. If sponsors create the trial without marking it as transitional, they cannot correct it at a later stage. They will have to create the trial from scratch, marking it this time as transitional. Once the trial has a recorded authorization in CTIS, all the requirements of the EU Clinical Trials Regulation (CTR) apply from the date of approval of the transition application. The sponsor needs to comply with their CTR obligations for the management of the trial and submit notifications as required (e.g., start of trial, start of recruitment). Moreover, any changes to the dossier need to be reflected in line with the CTR. Therefore, any subsequent substantial modifications submitted to the MSC need to comply with the CTR requirements.

More information can be found in the Clinical Trial Information System (CTIS) - Sponsor Handbook on the EMA CTIS website.