When preparing a proposal to an open Health Horizon call, be aware that the template for clinical studies has been revised. The Clinical Trials annex was updated in order to include complex trials and a reference to the mandatory use of Clinical Trials Information System (CTIS) (as per the Clinical Trials Regulation 536/2014).

In practice, from 31 January 2023, all initial clinical trial applications in the EU must be submitted via CTIS, which is now the single-entry point for sponsors and regulators of clinical trials for the submission and assessment of clinical trial data.

Transition period: The Clinical Trials Regulation foresees a three-year transition period, from 2022 to 2025. By 31 January 2025, all ongoing trials that were approved under the Clinical Trials Directive will be governed by the new Regulation and will have to be transitioned to CTIS.

The new version of the template for clinical studies will be used in the submission system of forthcoming topics and is currently published on the F&T portal under the following link.

Sources: EC, Euresearch