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This one-day course is intended for medical doctors, pharmaceutical professionals and researchers in the biomedical field who are involved in clinical research and need to write clinical study reports.

The course provides practical guidelines on the content of clinical study reports & appendices. You will learn what the report is used for, who are the key players, and the best practices in writing and reviewing a CSR. The full program is listed below, but the focus of this training will be on the following topics:

• Best practice in writing and reviewing a CSR
• Approval and distribution of CSR
• Changes to an approved CSR
• Guidelines on structure and content of a full CSR
• Ethics
• Study objectives & endpoints
• Investigational plan
• Statistical methods and sample size estimation
• Changes in the conduct of the study
• Synopsis
• CSR associated appendices
• Other reports than the full CSR

No prework is required for this training.

The workshop will be given by A. Dhoest. After obtaining her PhD at the University of Leuven (Belgium) and her postdoctoral research at the University of Ghent (Belgium), Dr. Dhoest has been working both in-house and freelance as a scientific writer for the pharmaceutical industry.

PharmaXL started in 2004 as a training center in order to fill the need for 'brain updates' in the pharmaceutical industry. The different workshops organized by PharmaXL have been attended by many medical and pharmaceutical professionals and students. This training is organized in cooperation with ECCRT.

This course will take place on May 16 and will be repeated on November 14, 2012 in the training facilities of ECCRT in Brussels, Belgium (Keizer Karellaan 576, 1082 Brussels).

* Students pay only 25% of the total fee. Please provide us with a document signed by the dean of your faculty as proof.

Please ask for our special group rates! If this training is combined with the training 'Protocol writing', the course fee is €950!

This subscription fee covers for the registration, coffee breaks, lunches and course material. The subscription fee does not cover for the hotel and/or travel expenses.

People who want to register for this course on clinical study report writing, please fill out the registration form.