Medical Writing Regulatory Writing Basics Profile: An interview with Laura McMahon on the role of clinical research coordinators in Italy

Volume 23, Issue 2 - Regulatory Writing Basics

Profile: An interview with Laura McMahon on the role of clinical research coordinators in Italy

Abstract

Clinical research coordinators (CRCs) – a CRC is not a clinical research associate but one is frequently mistaken for the other – have a fundamental role in clinical research. Their work involves a wide range of activities and responsibilities in conducting clinical trials according to good clinical practice under the immediate supervision of the principal investigator.

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Articles

Regulatory writing basics
Message from the President
A guide to pre-approval regulatory documents
Effective authoring of clinical study reports: A companion guide
The clinical study protocol and medical writing: A good fit?
The Investigator's Brochure: A multidisciplinary document
An overview of the Common Technical Document (CTD) regulatory dossier
Good clinical practice (GCP): A universal call for ethics in biomedical research
Adverse event reporting: A brief overview of MedDRA
The approval process of medicines in Europe
Recommended procedures for retracting articles: Inadequate and patchily applied? Analysis of a recent article in PLoS One
The needs assessment in continuing medical education
Origin and development of English for Medical Purposes. Part II: Research on spoken medical English
Did minor flaws in a new drug reveal major flaws in company publication practices?
What every medical writer needs to know
Profile: An interview with Laura McMahon on the role of clinical research coordinators in Italy
In the Bookstores
Journal Watch: Dedicated medical writing rotation for pharmacists, publication of drug industry funded research, and evidence-based medicine for clinical decision making
Regulatory Writing: The essence of regulatory writing as defined by its jargon
Medical Communication
News from the EMA
English Grammar and Style: Points of view
The Webscout
Gained in Translation: Science at the multilingual crossroads
Out On Our Own
The Light Stuff

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Raquel Billiones

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Victoria White

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Somsuvro Basu

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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

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Lisa Chamberlain-James

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Payal Bhatia

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Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Adriana Rocha

Out on Our Own

Tiziana von Bruchhausen

Pharmacovigilance

Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

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Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

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