How is a CTA structured?
A CTA is usually prepared in three separate Modules, which are in accordance with the International Conference on Harmonization’s (ICH) Common Technical Documentation (CTD) format:
Module 1
Administrative/Clinical Information:
This module houses the various forms, Investigator’s Brochure, protocol(s) and any information concerning the Research Ethics Boards (REB). This module is usually no longer than one volume.
Module 2
Common Technical Document Summaries:
This module summarizes, in specific forms, the chemistry and manufacturing information related to the investigated drug(s).
Module 3
Quality (Chemistry and Manufacturing):
This module contains the core data of the chemistry & manufacturing (quality) information. The extent of available supporting information may vary depending upon the stage of drug development.