CTR and CTIS

The conduct of clinical trials in the European Union (EU) has changed significantly since Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use – the Clinical Trials Regulation (CTR) – entered into force on 31 January 2022. The CTR aims to standardise the submission, evaluation and monitoring processes for clinical trials in the EU through the Clinical Trials Information System (CTIS).

Using CTIS

CTIS serves as a single point of contact for submitting information on clinical trials in the European Union (EU) and the European Economic Area (EEA). CTIS includes

• a workspace for clinical trial sponsors and the organisations cooperating with them,
• a workspace for authorities from the EU Member States, the EEA states, and the European Commission, and
• a public website.

The secure workspace for sponsors acts as an aid in the preparation and compilation of clinical trial applications and the corresponding documents for submission and evaluation.

The secure workspace for authorities supports the activities of EU Member States, EEA States, and the European Commission in the evaluation and monitoring of clinical trials.

The public website allows citizens to access detailed information on all clinical trials conducted in the EU and EEA once the studies have been submitted and approved in CTIS.

EU Member States and EEA states will assess and monitor clinical trials in CTIS, while the European Medicines Agency (EMA) will set up and maintain CTIS. The European Commission ensures the correct interpretation and implementation of the Clinical Trials Regulation.

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