Medical Writing Regulatory Writing Basics Effective authoring of clinical study reports: A companion guide

Volume 23, Issue 2 - Regulatory Writing Basics

Effective authoring of clinical study reports: A companion guide


Why write a clinical study report (CSR)? What are the guidance documents? Can I interpret them? Can I deliver my CSR on time?’ This article addresses these questions – and others, provides a companion guide to CSR authoring for preregistration drug trials intended for regulatory submission in the EU, provides links to applicable regulatory guidance documents, and offers experience-based insights. Between 2008 and 2013, the authoring timeline for a medium complexity first draft (mean [SD]: 16.9 [8.2]; range: 5–45 working days) and final CSR from the first draft (mean [SD]: 25.7 [21.1]; range: 3–120 working days) varied widely across the industry. Understanding regulatory requirements and utilising project intelligence leads to informed CSR authoring and scheduling, thereby assuring a high-quality, on-time, final CSR.

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  1. ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice E6(R1). Step 4, 10 June 1996. Available from:
  2. ICH Harmonised Tripartite Guideline: Structure and Content of Clinical Study Reports E3. Step 4, 30 November 1995. Available from:
  3. Official Journal of the European Union. II Information. Communication from the Commission. Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1) (2010/C 82/01). Available from:
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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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Lingua Franca and Beyond

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My First Medical Writing

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News from the EMA

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Regulatory Matters

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Regulatory Public Disclosure

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