Medical Writing Clinical Trials Peer review of a clinical trial protocol: Practical tips for regulatory medical writers, clinicians, and clinical scientists
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Volume 32, Issue 1 - Clinical Trials

Peer review of a clinical trial protocol: Practical tips for regulatory medical writers, clinicians, and clinical scientists

Abstract

Protocol development is a critical milestone in the clinical drug development process for all pharmaceutical companies conducting clinical trials. A regulatory medical writer (RMW) plays a crucial role in the protocol development and peer review processes along with different stakeholders. Poor peer review leads to protocol amendments, which delay regulatory submission and increase project costs. Thus, there is a strong need for RMWs and stakeholders to work together during the peer review process to highlight the specific issues that should be addressed before finalisation, which helps in creating effective, efficient, and high-quality protocols. The suggested protocol peer review steps described in this article will help an RMW to plan, coordinate, and deliver this highly important document for global and local clinical trials.

Medical Writing. 2023;32(1)20-27. https://doi.org/10.56012/fbfu9448

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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

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Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Deputy Managing Editor

Alicia Brooks Waltman

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 

Adriana Rocha

Freelancing

Ana Sofia Correia 

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Pablo Izquierdo / 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

Tiziana von Bruchhausen

Pharmacovigilance

Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Jeff Blair / Luiza Ventura

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Layout Designer

Chris Monk