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A protocol is the most important document in a clinical study as it is the foundation for subsequent operational, regulatory, and marketing objectives for the development program. 

Developing a protocol is an extensive undertaking that requires a cross-functional team and consideration of the position and role of the study in the full product development program. Before the protocol authoring process even begins, a variety of activities and decisions are necessary to establish a strategy for success. 

The following steps provide concepts and considerations that are essential in formulating the details that will become the protocol synopsis and ultimately the clinical study protocol.


10 Steps Essential to Formulating a Clinical Study Protocol

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