Lay协议简介：要求和可行性

Q2 Health Professions

Medical Writing Pub Date : 2023-03-15 DOI:10.56012/dwxn7122

Lisa Chamberlain James

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引用次数: 0

摘要

欧盟第536/2014号法规要求公司制作一份协议概要，并建议使用非专业语言版本。除其他外，这项要求规定了最长两页的篇幅。本文概述了该法规对《议定书纲要》的要求，并根据最大页数限制讨论了其可行性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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The Lay Protocol Synopsis: Requirements and feasibility

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.

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来源期刊

Medical Writing Health Professions-Medical Terminology

CiteScore

0.40

自引率

0.00%

发文量

期刊介绍： Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.