EMA - Survey on the Implementation of the CTR 536/2014

7th September 2023

EMA - Survey on the Implementation of the CTR 536/2014

In 2022, an EU survey was developed by the European Commission in collaboration with EMA, HMA, and the Clinical Trials Coordination Group (CTCG) to collect views from sponsors and stakeholders on the Clinical Trials Regulation (CTR) and the use of the Clinical Trials Information System (CTIS). A report was then published summarising the answers received, the identified problems and provided solutions.

Since the first survey was launched, CTIS has become mandatory for the submission of initial clinical trial applications. In parallel, CTIS functionalities have been improved, further guidance documents have been published, and CTIS user experience has improved.

EMA are now launching a second EU survey aimed at collecting further views of sponsors and stakeholders on this updated regulatory and IT environment, identifying the remaining blocking issues, in order to plan and monitor their resolution. The findings will be analysed and addressed under the ACT EU initiative, and identified issues will be tackled by the responsible entities (EMA, European Commission, Member States, Clinical Trial Coordination Group, Clinical Trials Advisory Group and Clinical Trials Expert Group).

You can access the survey using the following link: https://ec.europa.eu/eusurvey/runner/Second_Survey_CTR_implementation

You are kindly invited to complete this 20 minute survey by 4 October 2023.
Please note that a sponsor should submit only one response.

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