eCTD Module 5

CTD Module 5, also known as Module 5 eCTD, refers to the fifth module within a “common technical document” (or an “electronic common technical document” in the case of the “eCTD” acronym). The overall purpose of the CTD is to provide a common format for pharmaceutical companies submitting and registering a new or altered drug. Specifically, Module 5 refers to the presentation of clinical study reports, and within the “CTD triangle” image, is one of the base modules. CTD Module 5 is the same regardless of geography so companies from any area of the world would submit clinical study reports information using the same format.