December 2019: EMA Update

Clinical Trials Information System (CTIS) development

In December 2019, EMA’s Management Board endorsed to commence the audit of the system in December 2020, following an audit readiness assessment carried out by the nominated product owners, EMA and the IT supplier.

The aim of this assessment was to identify critical business blockers and resulted in an updated plan outlining items that still need to be developed or fixed for audit. The product owners will work with EMA and the IT supplier to analyse and design these items in the first few months of 2020, in a way that ensures efficient delivery.

The latest release of the system, which was validated by the nominated product owners in December 2019, enhances CTIS functionalities for processing the evaluation of clinical trial applications, data submission and view of data, management of user access, users’ oversight of activities and data transparency. These enhancements relate mainly to the authority and sponsor workspaces in the system.

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