Medical Writing Clinical Trials The Lay Protocol Synopsis: Requirements and feasibility
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Volume 32, Issue 1 - Clinical Trials

The Lay Protocol Synopsis: Requirements and feasibility

Abstract

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

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Articles

Editorial
President's Message
EMA Foreword
EMWA News
Bringing decentralised clinical trial protocols to life
Peer review of a clinical trial protocol: Practical tips for regulatory medical writers, clinicians, and clinical scientists
Transition to the EU Clinical Trials Regulation: Trick or treat?
The Lay Protocol Synopsis: Requirements and feasibility
Lay titles for clinical trials: Is industry achieving the balance?
To bias or not to bias in oncology clinical trials: Perspectives on design, endpoint selection, and reporting
The unique challenges of clinical trials in rare disease: A regulatory writer’s perspective
Clinical Investigations for Medical Devices
Clinical Trials in the Eurasian Economic Union
Clinical study reports: A snapshot for aspiring medical writers
Overview of the European General Data Protection Regulation (GDPR) impact on medical writing for clinical trials
Connecting the dots across the writing continuum
Trial Trivia
News from the EMA
Teaching Medical Writing
Regulatory Public Dislcosure
In the Bookstores
Veterinary Medical Writing
Lingua Franca
Good Writing Practice
Pharmacovigilance
Regulatory Matters
The Crofter: Sustainable Communications

Links

The Write Stuff Archive Contact Instructions for Authors Article Template (Word) Journal Policies

Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Associate Editors

Anuradha Alahari

Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

Sampoorna Rappaz

Amy Whereat

Section Editors

Daniela Kamir

AI/Automation

Jennifer Bell

Biotechnology

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News 

Ana Sofia Correia 

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh 

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Maddy Dyer

Publications

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Adriana Rocha

Out on Our Own

Tiziana von Bruchhausen

Pharmacovigilance

Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Layout Designer

Chris Monk