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EC - Good Lay Summary Practice Guidance

7th October 2021

This “Good Lay Summary Practice” (“GLSP”) provides recommendations on how to prepare, write, translate, and disseminate summaries of clinical trial results in lay language. This is a mandatory requirement laid out in Regulation (EU) No. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use  (“EU CTR”) and a transparency obligation to all trial participants and the interested public.

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