Topic: Clinical Study Protocol

Join Julia and Jonathan for the 2^nd part of a discussion dedicated to the development of Clinical Study Protocols as they delve into the intricacies of writing these crucial documents. In this discussion, they explore the level of involvement a writer should have to ensure a well-written protocol. Tune in to gain valuable insights and guidance on creating effective protocols that drive successful clinical studies.

In this episode, Julia and Jonathan cover how making people aware of the many new and updated regulations (such as the ICH E8(R1) and the draft ICH M11 guideline) will help ensure teams are following these, looking for ways to handle the ever more complex studies that are being designed, the importance of focusing on the regulatory objectives of a study over more academic pursuits, the value of using the Transcelerate template to get more standardization across the industry, and the importance of preparing protocols that communicate clearly and effectively not only to help users find the information they need but also to ensure teams are aligned on the full intentions of the study and for downstream use of the protocols in writing study reports and ultimately dossiers.