Overview of the Preparation Requirements for the ICH Common Technical Document

This course is an overview of how completed research studies are organized and summarized to be in compliance with the International Conference on Harmonisation (ICH) Common Technical Document (CTD – M4) guideline. Topics in this course include: Organization, QOS, Nonclinical Sections, Clinical Sections, and Modules 3, 4, and 5. After completing this course, learners will be able to identify the purpose of the CTD and ICH recommendations for summarizing and reporting data for completed research studies. Learners will also be able to recognize where to find more detailed information about the recommended CTD format for the three primary scientific areas (Quality, Safety, and Efficacy) that are part of a CTD.

After this course learners will be able to identify the purpose of the ctd and ich recommendations for summarizing and reporting data for completed research studies. recognize where to find more detailed information about the recommended ctd format for the three primary scientific areas (quality, safety, and efficacy) that are part of a ctd.