EMA Updated Clinical Trials Information System Development

On 12 March 2021 the EMA announced updated information on the clinical trials information system (CTIS).

CTIS is planning to go live by 31 January 2022. The final go-live date will be six months after the European Commission confirms the full functioning of CTIS through an independent audit.

Training materials on how to use CTIS are available to help clinical trial sponsors, national authorities, the European Commission, and other organizations comply with their obligations under the Clinical Trial Regulation (Regulation (EU) No 536/2014), which apply once the CTIS goes live. EMA will add new modules and materials throughout 2021.

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