Medical Writing Editing Anonymisation: A new challenge for medical writers

Volume 27, Issue 3 - Editing

Anonymisation: A new challenge for medical writers

Abstract

In its commitment to transparency, the EMA implemented Policy/0043 and Policy/0070 to make data accessible to all; however, this has given rise to the need for anonymisation of personal data in clinical reports. The analysis of the 64 submission packages containing anonymised data submitted to the EMA as of March 2018 shows that the most frequent technique to anonymise data is redaction. This is typically performed after reports are submitted to the competent authorities. The study report team, through a strong cross-functional strategy, can reduce the anonymisation required after submission of the document by proactively reducing the use of unnecessary identifiers in the initial report drafts. Therefore, the challenge for medical writers is to become involved in the anonymisation strategy and the creation of a data anonymisation plan for the clinical documents from their initial stages, focusing on the balance between scientific value and risk of re-identification.

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References

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Articles

Editing
President’s Message
EMWA News
Honing your proofreading skills
How clear is the story?
Editing for writers who have English as an additional language
Microediting – details matter Quality, authority, and reputation: The value of microediting
Revision: Parameters and practices within the translation industry
How to soften the red pen’s blow: Tips for editing a colleague’s work
Go certified – get ready for the BELS exam
Anonymisation: A new challenge for medical writers
Reports from the spring conference in Barcelona: 6th EMWA Symposium
Reports from the spring conference in Barcelona: EMWA social events programme
Reports from the spring EMWA conference. Expert seminar: Use of clinical study reports for Cochrane Reviews
News from the EMA
Profile: An interview with Richard Wheeler
Journal Watch
Medical Devices
In the Bookstores
Lingua Franca and Beyond
Regulatory Public Disclosure
Regulatory Matters
Medical Communication
Good Writing Practice
Manuscript Writing
Getting Your Foot in the Door
My First Medical Writing
Out on Our Own
Upcoming issues of Medical Writing

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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

Freelancing

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