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Meeting the EU Regulation: Plain Language Summaries & Protocol Synopses

On January 31, 2022, the European Medicines Agency (EMA) launched a new clinical trials website, Clinical Trials Information System (CTIS). The new website was launched with the application of the new clinical trials regulation, Regulation (EU) No 536/2014. The regulation requests a plain language version of the protocol synopsis to be submitted as part of the initial application for a clinical trial. CISCRP Colleagues & Industry Experts will discuss : -Creating a plain language protocol synopsis that can be used for non-expert audiences -Preparing plain language summaries of trial results to meet the new regulation -Best practices for developing and implementing a plain language summary program At the end of the webinar, attendees will: -Understand the required elements in a plain language protocol synopsis -Describe the best practices CISCRP has learned to date in the development of this deliverable -Know how to develop a plan to jump start a plain language summary of results program