PTF22 Managing the Clinical Study Protcol Writing Process

Description

Participant profile
This workshop is aimed at company 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.