A Master Format for Clinical Reports
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Drug lrfomrurion Joimud. Vnl. 3 3 . pp. 7XS-7XX. I999 Printed in the USA. All rights rererved.
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A MASTER FORMAT FOR CLINICAL REPORTS BARBARAWARNER, MD Institut de Recherche Pierre Fabre. Labege Innopole, France
The objective cf the tnnster report is to obtain the same high-quality imnge and te.rt f o r all clinical reports in conformity with Internutional Conjerence Jbr Harmonization (ICH) recommendations, as wrll as to sirnplifv titid shorten the process of mediccil writing. The suggested ICH format j i r c~liriicalstudy reports. guidelines developed by the Food and Drug Administrution (FDA), and recently published articles were integrated, providing a model clinical report including sample ubbreviations and references, suggested text jbr all chapters. and prototype tables. The master report was then formatted according to the electronic classijcution scheme used by the sponsor The master report is a 64page document in English that includes u guide f o r thr use of the master report and prefortnatted text cind tables in conji~rtnitynith ICll guidelines. Prefortnatted text, tables, and a diskette in ICH style were developed. Training has been prepared to facilitute the report :s use. Key Words: Master clinical report; Preformatted text; Clinical study report; ICH E3, FDA requirements
INTRODUCTION THE GOAL OF A CLINICAL study report is to fulfill the technical requirements for the registration of pharmaceutical products. The ICH guideline E3 (1 ) is intended to provide a suggested outline for an integrated full report of an individual clinical study. The report itself provides a clear explanation of the design, plan, methods, conduct, and results of the study. The structure and content of clinical reports, in the widest sense, are based on the writing of reports and scientific articles in general. The content (1,2) and specific conceptualization for particular reports have been described in detail elsewhere (3,4).The goal of drafting a master clinical report,
Presented at the DIA Workshop “Medical/Technical Wrihng and Associated Technologies.” September 2& 25. 1998. Paris, France. Reprint address: Barbara W m e r . MD. 7, rue de I’Altenbach. 68730 Michelbach-le-Bas, France.
which can be used as the general format for all clinical reports, is to standardize a highquality report for use in electronic classification systems in conformity with ICH recommendations; to simplify and shorten the writing process; and to clarify and strengthen the scientific phrasing in the introduction and discussion of the report.
MATERIALS AND METHODS A format was developed according to ICH ( 1) and FDA (2) guidelines using a literature
search (3-6) and adapting to requirements for biomedical journals, for example, using the Vancouver convention (7) for reference lists (section 15). Ideas from the literature were combined with the ICH outline to create a sample text for each ICH section and a flow of ideas was developed for each paragraph. A title page and model synopsis, already i
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