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Writing a Clinical Study Protocol

Drug Development
Workshop profile:
This workshop is aimed at new medical writers and experienced writers who are new to writing clinical study protocols. Other relevant workshops are “The Clinical Study Protocol: Content and Structure”, “Basic Concepts of Study Design in Clinical Development” and “Managing the Clinical Study Protocol Writing Process”.
The purpose of this workshop is to introduce medical writers to the components and concepts of a protocol, and to provide instruction on protocol writing. On completion of the workshop package, participants should feel confident about how to develop and write a protocol and how to manage the process.
The workshop will explain how to develop a protocol with practical examples and exercises. Participants will be introduced to the role of the study team in protocol writing. An outline will be given of regulations, guidelines, and sources of information. The pre-workshop assignment will be reviewed and used to build up a picture of the study. The influence of the study design on the protocol will be discussed. Development of the protocol synopsis will then be examined in detail, including discussion of study design and the relationship of the protocol with the Case Report Form. The workshop will then focus on the body of the protocol, i.e. filling in the details, including how to ensure that the study will be conducted as intended. This will be supplemented by the interactive workshop exercises, which are designed to get participants thinking in logical, practical sequence. The last part of the workshop will describe the ‘standard’ and administrative sections, appendices, and the ‘When, Why and How?’ of protocol amendments.