Clinical Trial Information System (CTIS) - Sponsor Handbook

On 29 July 2021 the EMA announced the availability of the handbook to help clinical trial sponsors preparing for using CTIS.

The aim of the EMA CTIS Sponsor Handbook (“Handbook”) is to provide clinical trial sponsors representing pharmaceutical industry, SME, academia, research organisations and other clinical trial sponsor organisations with the information they need for getting ready for use of the Clinical Trial Information System (CTIS) when the Clinical Trial Regulation (CTR: Regulation (EU) No 536/2014) comes into application. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via CTIS. CTIS will contain the centralised EU portal and database for clinical trials foreseen by the Regulation.

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