This is an invitation to share your thoughts on a draft guideline for writing the “Lay Protocol Synopsis” (LPS). As you may know, the LPS is an important regulatory requirement for all clinical trials in Europe (EU/EEA) and is meant to offer a clear and accessible summary of the trial protocol for everyone – not just specialists.
A core group within the “Good Lay Summary Practice” (GLSP) working group has prepared this draft guidance with the aim of going a step further than the existing “Clinical Trials Coordination Group’s“ (CTCG) Questions and Answers (version 7.1) document. Our goal is to provide practical, detailed advice that truly helps make clinical trial information understandable to all audiences.
You can find the draft and submit your comments via the Good Lay Summary Practice website – Public Consultation: Good Lay Protocol Synopsis Practice.
The public consultation is open until April 7, 2026. Thank you in advance for contributing to this important initiative!
