EU Clinical Trials Regulation - EMA Publishes Clinical Trial Information System Go-live Plan
On 8 October 2021, the European Medicines Agency (EMA) provided an update on the progress in the development and preparations for the ‘go-live’ of the Clinical Trial Information System (CTIS) on 31 January 2022. EMA also published a 12-page CTIS go-live plan summarising the key steps remaining before the launch of CTIS (the Plan; see, attached copy).
According to EMA and the Plan, CTIS is currently being extensively tested to identify any potential remaining stability issues. A key priority in preparing CTIS for launch is ensuring that the sponsor workspace is fully functional. Once this has happened, the workspace for health authorities will be finished, followed by the public portal. Other priorities are to set up a dedicated helpdesk for CTIS users and to prepare materials for “extended stakeholder training”. These materials will complement the existing training materials already issued by EMA, including online training modules and a sponsor handbook (see, Van Bael & Bellis Life Sciences News and Insights of 9 August 2021). Further preparations are also necessary to allow for clinical trial safety reporting and monitoring as included in the initial scope of CTIS activities.
The Plan provides for all of the outstanding matters a chart with a timeline for their implementation. In the first quarter of 2022, EMA will publish a follow-up plan focusing on the activities post 31 January 2022 which will cover post go-live releases, CTIS operation and maintenance, continued training offerings and stakeholder support and interaction.
CTIS is the cornerstone for the application of the EU Clinical Trials Regulation (i.e., Regulation (EU) No 536/2014 of 16 April 2014). Comprising an EU Portal and EU Database, CTIS will ensure a single-entry point for the submission of data and information relating to clinical trials by sponsors, evaluation and supervision by Member State health authorities, and access to publicly available data and information relating to clinical trials by the public (see, Van Bael & Bellis Life Sciences News and Insights of 22 April 2021 and Van Bael & Bellis Life Sciences News and Insights of 9 August 2021).