This session will provide an overview of the ICH M11 initiative for a harmonized protocol with a focus on the data models to ensure consistency using an open, nonproprietary standard to enable electronic exchange of clinical protocol information.
Learning Objectives
Describe the current deliverables and the latest developments on ICH M11 guideline, protocol template, and technical specification; Explain content and information models supporting the exchange and storage of clinical data and content in a protocol; Describe the Standards Development Organization (SDO) engagement process to enable electronic information exchange.
Tuesday June 27, 2023 8:30am - 9:30am CDT
TBDBoston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
