June 2020: EMA Update – Development of Clinical Trials Information System

The EMA Management Board Meeting took place on June 11, 2020. Following updates were provided on the development of the Clinical Trials Information System (CTIS) for the EU Clinical Trials Regulation:

The Board endorsed the methodology and next steps to further develop the Clinical Trials Information System (CTIS) ‘go-live’ plan. A group will be responsible for prioritising all outstanding issues to the CTIS governance and matching the items remaining after the audit to the capacity available before go-live and thereafter. This group will include representatives of the Member States product owners, sponsors product owners, as well as representatives from EMA and the European Commission. For the purpose of the prioritisation exercise, as a working assumption, it is proposed to fix the go-live date of CTIS to December 2021.

The Board noted that further operational assessments of various elements of CTIS were carried out in May, including the public portal and the publication of documents. This allows finalisation of the scope of the audit version of the system.

The Board also noted the progress in the development of CTIS made by the supplier. In view of the upcoming start of the audit in December 2020, a key milestone for CTIS, the Board decided to extend the monitoring of agreed key performance indicators until after the CTIS audit and to monitor the delivery of the items selected for audit and go-live.

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