Review of the European Union Clinical Trials Regulation: Key Early Learnings from the United Kingdom Drug Information Association Medical Writing Committee.

The European Union Clinical Trials Regulation (EU CTR) provides new regulatory requirements for the preparation and submission of clinical trial documents. The United Kingdom Drug Information Association Medical Writing (UK DIA MW) Committee, with members from across the pharmaceutical industry, have reviewed the EU CTR and in this report, provide expert guidance on writing documents for submission in the EU CTR Clinical Trials Information System (CTIS) portal. Medical writers should be aware that the Investigator's Brochure containing the Reference Safety Information (RSI) must align with the annual safety report, and the RSI format must comply closely with the EU CTR.