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…
