December 2020: EMA Clinical Trial Information System (CTIS) Update

EMA Management Board: highlights of December 2020 meeting were published on 18/12/2020. The section Update on the EU IT systems required by the Clinical Trial Regulation summarizes the progress with respect to CTIS.

Additionally, the EMA page for CTIS updates has been updated to include below post, which covers the key points from EMA management board meeting highlights:

In 2021, EMA plans to focus on:

  • the findings of a system audit;
  • improving usability, quality and stability of the CTIS;
  • knowledge transfer to prepare users and their organisations for CTIS.

​​​​​​​It is also working towards go-live in line with a plan developed together with the Member States and to deliver a minimum viable product (MVP). The CTIS programme governance is responsible for agreeing what the MVP will consist of.

Go live is planned in December 2021.

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