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20th January 2021
The way clinical trials are conducted in the EU will undergo a major change when the Clinical Trial Regulation (Regulation (EU) No 536/2014) comes into application. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS). CTIS will contain the centralised EU portal and database for clinical trials foreseen by the Regulation and will be used by clinical trial sponsors as a single entry point in the EU to obtain approval for clinical trials based on applications and for monitoring clinical trials during their life cycle, including the submission of summary of results.
The system is currently under development and will have collaboration and communication tools, workflow and document management capabilities. It will include a user management tool to enable access for sponsors, Member States and the European Commission via dedicated workspaces. It will also provide general public with access to clinical trials information. CTIS will centralise the submission process for clinical trial applications and the assessment and authorisation by Member States in a single unique platform. It will facilitate day-to-day business processes of Member States and sponsors of clinical trials throughout the lifecycle of a clinical trial harmonising submission and maintenance of trial applications, assessment and supervision of trials and promoting patient safety and transparency.
The Clinical Trials Regulation, Regulation (EU) No 536/2014, will become applicable as CTIS goes live, which is anticipated in December 2021. Once launched, CTIS will be immediately available for authorities and for clinical trial sponsors, while a three-year phased transition period from the current Directive 2001/20/EC to the Regulation will apply.
To facilitate preparedness for use of CTIS users, the European Medicines Agency has developed a training programme to provide future CTIS users with the skills and knowledge to successfully use CTIS into their business. A wide array of comprehensive online training material will be made available gradually in 2021.
For Micro, Small to Medium Enterprises (SMEs) and academia, EMA is organising a targeted webinar to provide training on CTIS and its functionalities. The webinar is divided into two parts (Day 1 and Day 2) and participants are advised to attend both. This two-part event is free of charge.