Medical Writing Clinical Trial Transparency and Disclosure Protection of personal data and commercially confidential information under the Clinical Trials Regulation (EU) No. 536/ 2014 – EMA “Revised CTIS Transparency Rules"
mew-333-cover-pagepdf

Volume 33, Issue 3 - Clinical Trial Transparency and Disclosure

Protection of personal data and commercially confidential information under the Clinical Trials Regulation (EU) No. 536/ 2014 – EMA “Revised CTIS Transparency Rules"

Abstract

The Clinical Trials Regulation (EU) No 536/2014 (CTR) came in force on January 31, 2022, specifying requirements for performing clinical trials in the EU and the European Economic Area (EEA). The CTR and the Clinical Trials Information System (CTIS) harmonise the approval process of clinical trials across the EU/EEA, provide a transparent process, and increase public access to information from clinical trials. Such transparency efforts must assure protection of personal data and commercially confidential information. The CTIS transparency rules were revised and recently implemented. The revised CTIS transparency rules focus on easier and earlier access by the public to documents of primary focus for patients and researchers. This article highlights the protection of personal data and commercially confidential information in public clinical trial documents according to the revised rules and also the EMA Policy 0070, which have overlapping transparency requirements. Medical writers and other functions involved in the preparation of regulatory documents during the clinical drug development play an integral role in applying transparency principles.

 

Medical Writing. 2024;33(3):12–21. https://doi.org/10.56012/frkj6889

Download the full article

Search

Articles

Clinical trial transparency and disclosure from the medical writing perspective
From the Editor
President’s Message
EMWA News
Protection of personal data and commercially confidential information under the Clinical Trials Regulation (EU) No. 536/ 2014 – EMA “Revised CTIS Transparency Rules"
Making the leap: Transparency requirements for clinical trials moving from one regulatory framework to another
Navigating the complex landscape of clinical trial transparency: What medical writers need to know
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

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

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