Dato: 24. september 2012 - 25. september 2012 Formål: This course will provide you with an in depth understanding of the requirements for skilled reporting of clinical studies, including the use of international guidelines, best practice, quality considerations and useful writing, planning and execution tips. Indhold:Effective Medical Writing provides thorough introduction to the statistical background, statistical analyses and data display. - Writing a Clinical Study Report (CSR) - Statistical basis of trial design and analysis, interim analysis and multiple testing, primary vs secondary variables and efficient data display - Understanding safety data collection and reporting - Quality awareness – best practices for reviewing and proofreading as well as quality control processes - Transforming the CSR into an accurate and persuasive publication Målgruppe: The course is aimed at employees within clinical research, who are responsible for the reporting of clinical studies and who have little or no experience with writing and compiling the clinical study report. The course is also aimed at employees who wish to improve their understanding of the interpretation and reporting of clinical data, including those who only occasionally write research documentation or scientific publications. Forudsætninger: The course is taught in English. |