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Topic: Clinical Study Report

Episode 13: Q&A with TriloTalk: Focus on CSRs
In this special session of TriloTalk, Julia and Barry answer questions sent to them by medical writers around the world. The focus of the questions in this episode is Clinical...
Do We Need to Involve Patients in Clinical Study Report Lay Summaries?
Translating complex clinical regulatory documents into versions that are understandable to patients and the general public was never going to be an easy task, but it is a very necessary, important, and now legally mandated one. This article argues that the advent of the clinical trial results lay summary requirement has highlighted the need for patient involvement in clinical trials at the very earliest stages.
Author: Lisa Chamberlain James and Barry Drees
Journal: Regulatory Rapporteur
Date: Vol. 17, Issue 9, September 2020