January 2022: CTIS Highlights

The seventh issue of CTIS Highlights was published on January 27, 2022. It provides a brief insight about the CTIS website, the transition from clinical trials regulation to CTIS, upcoming training courses that will assist future users in preparing for CTIS.

It provides an update about a new clinical trial website that will be launched by EMA on January 31, 2022, to support the launch of CTIS. The URL for the Clinical Trials website will be made available on the EMA website and social media channels. This public website would provide information on CTIS and would also allow users to search information for clinical trials authorized by CTIS.

It also provides an update on several upcoming end-user training courses that are scheduled from February 2022 to June 2022. EMA also provides extensive online training modules to assist users in preparing for CTIS. The “CTIS Sandbox-CTIS training environment” Survey is now reopened for the sponsor who did not respond in October 2021.

The incoming Clinical Trials Regulation on January 31, 2022, would pace the implementation of Accelerating Clinical Trials in the EU (ACT EU). The joint controllership arrangement has been established that describes the processing of personal data in CTIS, in accordance with the General Data Protection Regulation and EU Data Protection Regulation.

The newsletter also describes a query management process that receives queries from associations at the EU level. Sponsors would contact their national or EU-level associations with their queries and these associations would prioritize a list of questions for sharing with EMA, the European Commission, and the Member States.