Medical Writing Regulatory Writing Basics Effective authoring of clinical study reports: A companion guide
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Volume 23, Issue 2 - Regulatory Writing Basics

Effective authoring of clinical study reports: A companion guide

Abstract

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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References

  1. ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice E6(R1). Step 4, 10 June 1996. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf
  2. ICH Harmonised Tripartite Guideline: Structure and Content of Clinical Study Reports E3. Step 4, 30 November 1995. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf
  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: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2010:082:0001:0019:en:PDF
  4. European Medicines Agency Press Release ‘European Medicines Agency launches a new version of EudraCT’ [2013 October 11]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fnews_and_events%2Fnews%2F2013%2F10%2Fnews_detail_001918.jsp
  5. Publication and access to clinical-trial data. London: European Medicines Agency. Policy 0700. Draft for public consultation [2013 June 24]. Available from: http://www.ema.europa.eu/ema/doc_index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500144730&murl=menus/document_library/document_library.jsp&mid=0b01ac058009a3dc
  6. ICH E3 Guideline: Structure and Content of Clinical Study Reports Questions & Answers (R1) [2012 July 6]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_QAs_R1_Step4.pdf
  7. ICH Topic M4E. Common Technical Document for the Registration of Pharmaceuticals for Human Use. Clinical Overview and Clinical Summary of Module 2. Module 5: Study Reports. (CPMP/ICH/2887/99 – Efficacy) [July 2003]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002723.pdf
  8. Seiler W. The clinical study protocol and medical writing: A good fit? Medical Writing 2014;22(2):93–95.
  9. ICH Harmonised Tripartite Guideline: Statistical Principles for Clinical Trials E9. Step 4, 5 February 1998. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf
  10. CHMP Note for Guidance on the Inclusion of Appendices to Clinical Study reports in Marketing Authorisation Applications. CHMP/EWP/2998/03/Final 23 June 2004. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003638.pdf
  11. Alfaro V, Cullell-Young M, Tanovic A. Abbreviated clinical study reports with investigational medicinal products for human use: Current guidelines and recommendations. Croat Med J 2007;48(6):871–77.
  12. FDA CDER and CBER. Guidance for Industry: Submission of abbreviated reports and synopses in support of marketing applications. August 1999. Available from: http://www.fda.gov/downloads/Drugs/Guidances/ucm072053.pdf
  13. Hamilton S. Effective scheduling of clinical study reports. The Write Stuff 2008;17(3):133–34.

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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?
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An overview of the Common Technical Document (CTD) regulatory dossier
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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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