Abstract
The clinical study report describes the results of a single human study and thus represents the most fundamental building block in a drug product’s argument for use in humans. The results of all human trials conducted by a drug or biologics company must be recorded in some type of report, although the type of reporting may vary. This chapter describes a clinical study report as defined by the International Conference on Harmonisation (ICH) in the E3 Guideline [1], which is the type of report used for most clinical studies conducted in the three major geographic regions (Europe, Japan, and the United States) and is referred to as a “full” clinical study report in this chapter.
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References
ICH E3, Guideline for Industry, Structure and Content of Clinical Study Reports, July 1996.
Guidance for Industry, Submission of Abbreviated Reports and Synopses in Support of Marketing Applications, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) August 1999. http://www.fda.gov/cber/gdlns/abbrev.htm. (Accessed 15 April 2008).
International Committee of Medical Journal Editors. Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication. Updated October 2005. Available at http://www.icmje.org. (Accessed 11 January 2006).
The World Medical Association, Policy, World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. http://www.wma.net/e/policy/b3.htm (Accessed 27 March 2007).
Title 21 — Food and Drugs Chapter I — Food and Drug Administration Department of Health and Human Services. Subpart B — Investigational New Drug Application (IND) §312.30 IND safety reports. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm. (Accessed 30 March 2008)
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© 2009 Birkhäuser Verlag Basel/Switzerland
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Wood, L.F. (2009). Clinical study reports. In: Wood, L.F., Foote, M. (eds) Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics. Birkhäuser, Basel. https://doi.org/10.1007/978-3-7643-8362-6_6
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DOI: https://doi.org/10.1007/978-3-7643-8362-6_6
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