Regulatory, scientific and operating requirements, concerns and objectives are contributing to: (1) increased complexity in protocol designs, clinical study report submissions, and study results reporting; (2) higher levels of planning and operating inefficiency. This symposium explores opportunities to realize substantial cycle time and cost savings through improvements in protocol design planning, standardized clinical study report authoring and the implementation of best disclosure practices.

Learning Objectives:
Summarize drivers of protocol complexity, the incidence of protocol amendments and unused and excessive clinical data
Identify new approaches to minimize protocol complexity, prevent amendments and reduce the amount of unused clincal data
Explain ICH guidelines nad discuss solutions allowing greater consistency and predictability in authoring CSRs for submission
Describe public disclosure requirements Describe best practices to achieve content disclosure consistency