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:
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.
Common Technical Document Summaries:
This module summarizes, in specific forms, the chemistry and manufacturing information related to the investigated drug(s).
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.