RGA 6207 — Global Impact of Electronic Common Technical Document (eCTD) Submissions
4 semester hoursGraduateLecture
Examines the structure of the Common Technical Document (CTD) format through study of both regulatory requirements as well as example submissions. Offers students an opportunity to develop an understanding of FDA's geographically specific eCTD submission requirements. Students review and receive didactic instruction in the basic structure and technical format of an eCTD submission, the use of statistical models to present data, and the differences between the electronic format and former paper-based CTD submissions.