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. We have outlined the concepts and considerations that are essential in formulating the details that will become the protocol synopsis and ultimately the clinical study protocol.