EMA Management Board – highlights of March 2020 meeting

On 20 March 2020 the EMA highlighted the update on the development of the Clinical Trials Information System (CTIS) for the EU Clinical Trials Regulation.

The Management Board endorsed the CTIS audit methodology enabling the process for the selection of the supplier for the audit of the system to commence. The audit is planned to begin in December 2020.

Further to the endorsement in December 2019 of the ‘audit readiness assessment’ the Board noted that a second assessment is being carried out in the first months of 2020 to further identify critical items that must be addressed prior to the audit. So far, the Union Control and Inspection modules of CTIS have been assessed by specialised users in those areas, in collaboration with the product owners. This assessment will be completed in April 2020 and will be followed by a further operational assessment including of the public portal to allow determining the full scope of the auditable version of the system.

The Board also noted the progress in the development of CTIS by the supplier, with reassurance being provided by the results of the last sprints. The supplier performance and quality will continue to be closely monitored to ensure timely delivery of a reliable audit version of CTIS.

Read more online
Copyright Widler & Schiemann AG 2020. All Rights Reserved. /