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Glossary

Lay Person Summary (of a clinical trial)

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The EU Clinical Trials Regulation 536/2014 (Article 37) requires sponsors to provide summary results of clinical trials in a format understandable to laypersons. These lay person summaries will be made available in the EU Portal and Database.

Other glossary definitions

M

Market Exclusivity

The 10-year period after the marketing authorisation of an orphan medicine when similar medicines for…

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Q

Quality-by-Design(QbD)

Quality by design (QbD) is an approach that aims to ensure the quality of medicines…

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