Article 37 of the EU Clinical Trial Regulation requires sponsors to publish a plain-language summary alongside the technical CSR. The teams that treat it as a content task end up writing twice. The teams that treat it as a clinical translation task write once and pass review.
EU CTR Article 37 made plain-language summaries mandatory. Most teams scope them as a content task. They’re a clinical translation task, and the difference matters when EMA reviews the lay summary alongside the protocol.
