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The Lay Protocol Synopsis: Requirements and feasibility

Authors: Lisa Chamberlain James

The EU Regulation 536/2014 included a requirement for companies to produce a Protocol Synopsis with a recommendation for a version in lay language. This requirement stated, among other things, a maximum length of two pages. This article outlines the requirements of the regulation with respect to the Protocol Synopsis, and discusses their feasibility in light of the maximum page limit. Medical Writing. 2023;32(1)34-36. https://doi.org/10.56012/dwxn7122

Medical Writing. 2023;32(1):34–36

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