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Oral presentation

This workshop addresses specific topics related to medical writing and particular aspects of the integrated clinical report. Throughout the workshop active participation of delegates will be encouraged to allow identification of day-to-day difficulties.

Common mistakes in grammar, aspects of good style like effective paragraphing and clear wording, as well as typical medical terminology will be covered. Choice of active or passive voice, proper use of tenses, common spelling errors, punctuation, capitalization, use of hyphens, quotation marks, apostrophies, and differences between British and American English will be discussed. Techniques presented to improve simplicity and clarity of style will include linking of passages and construction of paragraphs, building of strong sentences and use of thought-assisting parallelisms. Commonly encountered mistakes in medical English will be pointed out. Theoretical knowledge will be underscored by practical exercises.

Common types of reports and papers will be briefly mentioned. The main emphasis of the afternoon session will be focused on the ICH Guideline on Structure and Content of Clinical Study Reports (E3, CPMP/ICH/137/95). The report structure and possible modifications, the synopsis, the body of the report, preparation of in-text and appended tables and figures, the statistical plan and actual analyses, the presentation of adverse events including case narratives, and the organization of the appendices will be detailed. Important points to consider when finalizing the report will be discussed including checks for completeness, consistency, and cross-references as well as correct grammar. Checklists will be assembled to avoid time-consuming and unnecessary errors and their corrections.

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