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A compilation of key guidance, technical information, recommendations and references for getting ready for the use of CTIS

Executive summary

The aim of the EMA CTIS Sponsor Handbook (‘Handbook’) is to provide clinical trial (CT) sponsors representing pharmaceutical industry, SME (small and medium-sized enterprises), academia, research organisations and other clinical trial sponsor organisations with the information they need to navigate the Clinical Trials Information System (CTIS) – to create and submit clinical trial information to the member states of the European Union as required by the Clinical Trial Regulation [CTR: Regulation (EU) No 536/2014]. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU/EEA, via CTIS. CTIS contains the centralised EU portal and database for clinical trials foreseen by the Regulation.

The Handbook addresses key questions on CTIS and provides a compilation and references to key guidance, technical information, recommendations, training materials, and supportive documentation to facilitate the submission and assessment of CTAs and additional information during the lifecycle of a trial.

It has been developed by the European Medicines Agency (EMA) in collaboration with representatives of industry stakeholders.

The Handbook will be revised as more information becomes available, or system functionalities are updated. It is best used in conjunction with the many references to which it points, for example, Volume 10 of the publication ‘The rules governing medicinal products in the European Union’ that contains guidance documents applying to clinical trials (EudraLex – Volume 10 – Clinical trials guidelines).