EU Directive: Layperson Summary
For those of you involved in global clinical trials, specifically including participants from Europe, you may have seen an increase in the activity related to lay person summaries.
The key reason for this relates to EU regulation 536/2014, which must be in place by 2020.
This regulation requires Sponsors to provide both a summary of clinical trial results and a layperson summary for all Phase I-IV interventional trials, when at least one site is in the EU.
Annex V of the regulation details the 10 essential elements of a layperson summary
For more information the following links may be useful
health/sites/health/files/ files/eudralex/vol-1/reg_2014_ 536/reg_2014_536_en.pdf
transceleratebiopharmainc.com/ wp-content/uploads/2017/02/ Implementation- Recommendations_20Jan17_Final. docx
This article has been written and provided to NZACRes by Zoe Breeze, Roche Products NZL