The Clinical Trial Regulation harmonizes the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS). CTIS will contain the centralized EU portal and database for clinical trials foreseen by the Regulation. The CTIS's go-live date has been postponed due to technical difficulties with the development of the IT system.
The Management Board noted the progress in the development of the CTIS audit version which is on schedule for audit starting in November 2020. The first meetings with the independent audit team have taken place in preparation for the audit.
The group responsible for prioritizing all outstanding issues to the CTIS governance and matching the items remaining after the audit to the capacity available before and after go-live has been established and has made good progress. This group includes representatives from Member States and sponsors, as well as EMA and the European Commission. For the purpose of the prioritization exercise, as a working assumption, the go-live date of CTIS remains December 2021.
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