The Lay Protocol Synopsis: Requirements and feasibility
Autor: | Lisa Chamberlain James |
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Rok vydání: | 2023 |
Předmět: | |
Zdroj: | Medical Writing. 32:34-36 |
ISSN: | 2047-4814 2047-4806 |
Popis: | 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. |
Databáze: | OpenAIRE |
Externí odkaz: |