Course Description

The Clinical Study Report (CSR) is a critical document in the drug development and regulatory submission process. This web seminar presents the basic tools required to generate CSRs for the pharmaceutical industry. Participants will learn the elements of the CSR and the appendices, methods for turning the protocol and statistical outputs into one cohesive document, the basics of writing and preparing a document for submission, and the guidances to follow for reference.

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Learning Objectives

• Translate protocol and data into clear concise submission documents
• Describe the elements required for the CSR and the appendices
• Differentiate the various types of statistical outputs and handling of the results
• Identify the phase of drug development differences and similarities
• Utilize style guides and templates

Who Should Attend

• Medical Directors
• Medical Writers
• Clinical Research Associates
• Clinical Scientists
• Research and Development Personnel
• Regulatory Affairs Professionals
• CRO Personnel

Instructor

Caroline Ritchie, Ph.D., M.B.A.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.