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Managing the Clinical Study Protocol Writing Process

Level:
Foundation
Area:
Professional Techniques
Code:
PTF22
Duration:
03:00:00
Workshop profile:
This workshop is aimed at staff and freelance medical writers who are interested in learning how they can make an effective contribution to the protocol writing process by taking a leading role. Previous participation in the workshop on The Clinical Study Protocol is recommended.
Objective:
The objective of this workshop is to present the process of study protocol preparation to medical writers as a type of project management. The emphasis will be on the process of how the medical writer can effectively lead the preparation, review, and finalization of a clinical study protocol as a member of a multifunctional team. Study protocol writing will not be discussed in detail. Upon completion of this workshop, participants should be better prepared to work efficiently within a complex and at times quickly changing environment.
Content:
The workshop will cover the role of the medical writer in leading the protocol writing process as a member of a multifunctional team. Best practices (do’s and don’ts) will be covered showing how a medical writer can best lead the team through the different steps in the process (from the kick-off meeting with the study team to the finalisation of the document)... Useful tools and practical approaches that can make the process easier will be presented.