Home » EMA Says Clinical Trial Regulation to Go Live in January 2022
EMA Says Clinical Trial Regulation to Go Live in January 2022
The EU’s long-delayed Clinical Trial Regulation (CTR), a sweeping set of new rules, will take effect in early 2022 now that its new clinical trials database has been proven ready for launch.
Originally scheduled to go live in September 2018, the Clinical Trials Information System (CTIS) had been held up by technical problems, but an independent audit has now confirmed the database and its submission portal are fully functional (CenterWatch Weekly, Jan. 4, 2021).
Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials
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