Medical Writing Public Disclosure Preparing clinical study reports for external sharing

Volume 27, Issue 2 - Public Disclosure

Preparing clinical study reports for external sharing

Abstract

As the EMA refines its requirements for the external publishing of clinical study reports, the workload of medical writing teams is increasing to include robust processes for clinical study report anonymisation. Until now, life sciences firms have played this safe by using heavy content redaction (covering up identifying information with a blue box), but now EMA is encouraging anonymisation over redaction to help maximise data utility while simultaneously mitigating the risk of patient identification. (Anonymisation involves changing identifiers, but they are still readable, such as placing an age of 27 into a band of 20–29). This article explores the issues and considers companies’ options.

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Articles

Editorial
President’s Message
EMWA News
The Regulatory Public Disclosure Special Interest Group
Clinical trial disclosure and transparency
Navigating the EMA clinical data website
Anonymisation reports from 2016 to 2017: A preliminary analysis
Preparing anonymisation reports in general and for an orphan drug in particular
Policies 0070 and 0043: Juggling different requirements
Clinical data publication by the EMA: The challenges facing the pharmaceutical industry
Clinical trial results disclosure on ClinicalTrials.gov and EudraCT
Writing lay summaries: What medical writers need to know
Lay titles for clinical trials: A balancing act
Why clinical study reports really matter
CORE Reference – a tool for modern clinical study reports in an era of increasing transparency and disclosure
Preparing clinical study reports for external sharing
Harmonising format and style requirements for scientific and medical publications
News from the EMA
Winners of the Geoff Hall Scholarship Essay Competition
Creative medical writing: An oxymoron?
Creative medical writing - An oxymoron?
An interview with Chris Winchester
Journal Watch
In the Bookstores
Good Writing Practice
Medical Devices
Getting Your Foot in the Door
Out on Our Own
Upcoming issues ofMedical Writing

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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 Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Clare Chang

Barbara Grossman

Joselita T. Salita

Amy Whereat

Section Editors

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News       

Aurélie Gobet / Paolo Rega

Gained in Translation

Raquel Billiones

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh / Stephen Gilliver

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

Manuscript Writing

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Namrata Upadhyay

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Jennifer Clemens

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Karim Montasser

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Lay out Designer

Chris Monk