EMA update on Clinical Trials Information System

The European Medicines Agency’s (EMA) Management Board held its first meeting in Amsterdam on 21 March.  In meeting highlights released 22 March,  EMA provided the following update on the Clinical Trials Information System (CTIS):

The Board was updated on the status of the ongoing development of the Clinical Trials Information System (CTIS – formerly the EU clinical trial portal and database). The project plan has been revised to improve delivery and to ensure that stakeholders can give feedback more regularly during the process so that their expectations can be taken into account, whilst enabling the legislation to come into application as early as possible, but retaining the possibility to extend functionalities in the future.

The contract for the delivery of the system has been restructured, so that the code of the safety reporting can be merged with EU clinical trial portal and database system modules, key bug fixing can be carried out and the system can then enter a phase of iterative, agile development as of June 2019. This approach will support the further enhancement of the system, in close interaction with the user community, through the audit and until after the system has gone live and the Clinical Trial Regulation has entered into application. Further announcements will be made before user acceptance testing commences on the release that will be subject to audit. The Agency and the Member States are fully committed to ensuring the success of this project and its delivery.