Meeting the EU Regulation: Plain Language Summaries & Protocol Synopses

On January 21, 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.

Hear from CISCRP colleagues and industry experts who 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, and best practices for developing and implementing a plain language summary program.


Julie Faries-Mitchell, MS

Associate Director

Health Communication Services


Christopher Pfitzer

Associate Director

Transparency Operations Lead

UCB Biosciences, Inc.

Kim Edwards, PhD

Associate Director

Medical Writing


To access more educational content about clinical trials and clinical research participation click here. 

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