The summary of results and layperson summary of results are generally expected to be submitted within one year from the trial’s completion unless the trial includes paediatric participants, in …

The CT Regulation8 establishes an overall timeline of 50 days for the Member States to evaluate a substantial modification. This deadline may be extended in case that Requests for …

By January 30, 2025, all ongoing clinical trials in the EU must be transferred to the CTIS. This deadline marks the end of the three-year transition period that started when the CTR took effect.

The revised CTIS transparency rules became applicable on 18 June 2024, with the launch of a new version of the CTIS public portal. The quick guide for users provides a summary of what …

Aug 12, 2025 · Under Regulation (EU) No. 536/2014, all interventional trials conducted in the EU must include a lay summary submitted through the Clinical Trials Information System (CTIS). …

With the January 31, 2025 deadline fast approaching, all ongoing clinical trials must be transitioned to CTIS to comply with the EU Clinical Trials Regulation (CTR).

Where a clinical trial has had to close early, the information included in the summary should explain the reason for this, for example, evidence of lack of efficacy, safety events, poor …

In 2014, the EU introduced a new regulation: EU CTR 536/2014.1 This regulation replaced the previous Clinical Trials Directive 2001/20/EC,2 and became mandatory with the opening of the …

Jan 31, 2022 · The Clinical Trials Information System (CTIS) supports the flow of information between clinical trial sponsors, European Union (EU) Member States, European Economic …

Apr 11, 2022 · Sponsors must upload a lay summary that will then be publicly accessible through the Clinical Trials Information System (CTIS). After a transition period of 3 years, the …