How To Write A Protocol For A Clinical Study

This course will provide a structured approach to writing protocols and is intended for ths who are new to this area. Protocols are the cornerstones of clinical studies. A protocol that is not well written can lead to many protocol amendments or event failure of the study. This course is about how to write good protocols. The rules and regulations governing protocols will be reviewed and practical advice will be given to delegates aboutwhat information should be included in each section of the protocol. What appendices to include in a protocol will also be discussed, as well as the benefits and drawbacks of each. The day will finish with a session of hints and tips on how to handle protocol amendments. By the end of this course, you will be able to: - write a protocol that is clear - write a protocol that is complete and compliant with regulations and guidelines.

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