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February 2023

Safety Observer 197

A new “quick guide for sponsors” has been published to support compliance with the EU Clinical Trials Regulation.

Released 06-Feb-2023
Pages 32
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Report 197 — Highlights

EU CTR milestone

The Clinical Trials Information System (CTIS) went live on 31-Jan-2022 and following the first year into the transition period, the EU Clinical Trials Regulation (CTR) has now become mandatory for all initial trial applications, which are required to go through CTIS.

EU CTR “quick guide”

The European Commission has published a new document as part of Eudralex Volume 10. This new “quick guide for sponsors” is intended to support compliance with the rules and procedures of the EU Clinical Trials Regulation.

FDA Draft Guidance

The FDA has published a new draft guidance on Externally Controlled Trials, which is the latest addition in the series of documents to support the Agency’s Real-World Evidence (RWE) Program.

Day 0 for Literature ICSRs

The EMA Pharmacovigilance Inspectors Working Group has produced a new Q&A, which presents its interpretation of the requirements regarding Day 0 for ICSRs described in local journals.

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