This guidance was published by the European Medicines Agency (EMA), and it serves as a comprehensive guide for sponsors on how to use the CTIS, which is a system designed to streamline the submission and management of clinical trials in accordance with the EU Clinical Trials Regulation (EU CTR). 

It covers various aspects mentioned below: 

  • The EMA CTIS sponsor handbook provides clinical trial sponsors with the information they need to navigate the Clinical Trials Information System (CTIS) and create and submit clinical trial information to the member states of the European Union
  • The handbook includes information on user registration, management, and roles, as well as data fields, documentation, and processes for clinical trial applications, safety reporting obligations, and data transparency
  • The Clinical Trials Information System (CTIS) is an electronic platform that provides a harmonized and simplified end-to-end application procedure for clinical trials across the EU/EEA, including submission to national competent authorities and ethics committees
  • CTIS offers increased transparency and searchable clinical trial information to patients, healthcare professionals, and the general public, while also enhancing patient safety through a harmonized safety assessment and electronic reporting of adverse reactions
     

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Source
https://www.ema.europa.eu/en/documents/other/clinical-trial-information-system-…
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