Medical Writing Clinical Trial Transparency and Disclosure The 2023 CORE Reference Utility Survey: Perceptions on a best practice tool for globally applicable clinical study reporting and provision of continuing professional development resources for the regulatory medical writing community
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Volume 33, Issue 3 - Clinical Trial Transparency and Disclosure

The 2023 CORE Reference Utility Survey: Perceptions on a best practice tool for globally applicable clinical study reporting and provision of continuing professional development resources for the regulatory medical writing community

Abstract

CORE Reference offers globally applicable resources for clinical study reporting, including a user manual and a mapping tool, and continuous professional development (CPD) resources. This report presents the results of the 2023 Utility Survey conducted by the CORE Reference Project Team to measure the awareness and perceived usefulness of these resources by the regulatory medical writing community. The survey found an increased use of the CORE Reference open-access manual, compared to results of the 2017 survey. Most respondents found the resources extremely, or somewhat, useful for preparing disclosure-ready clinical study reports. Over half of the respondents were aware of the CORE Reference CPD resources. Most respondents found the bi-monthly news summary extremely, or somewhat, useful. One-third of the respondents required knowledge of the reporting and public disclosure landscape in Asia and found the updates of Asia extremely, or somewhat, useful. The survey results indicate a positive reception of the CORE Reference Project amongst regulatory medical writers.

Medical Writing. 2024;33(3):38–45. https://doi.org/10.56012/rnqo6114

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Articles

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President’s Message
EMWA News
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Making the leap: Transparency requirements for clinical trials moving from one regulatory framework to another
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Plain language summaries of clinical trial results: What is their role, and should patients and AI be involved?
The 2023 CORE Reference Utility Survey: Perceptions on a best practice tool for globally applicable clinical study reporting and provision of continuing professional development resources for the regulatory medical writing community
Creating educational materials about clinical research data for patients and the public: A multifaceted journey in the current digital age
Publisher perspectives on plain language summaries of scientific publications: An Open Pharma survey
Medical writing in Italy in 2024: Results of the first Italian business and compensation survey
News from the EMA
Digital Communication
Medical Communications and Writing for Patients
Regulatory Public Disclosure
In the Bookstores
Publications
The Crofter: Sustainable Communications
Good Writing Practice

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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