The Lay Protocol Synopsis: Requirements and feasibility

Autor: Lisa Chamberlain James
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