October 2020: Development of Clinical Trials Information System (CTIS)

The Highlights of Management Board: October 2020 meeting were published on October 05, 2020. The report provides following information with respect to the development of the CTIS:

The Board noted the progress in the development of the Clinical Trial Information System (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 prioritising 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 prioritisation exercise, as a working assumption, the go-live date of CTIS remains December 2021.

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