A CTA is usually prepared in three separate Modules, which are in accordance with the International Conference of Harmonization’s (ICH) Common Technical Documentation (CTD) format: Module 1 Administrative/Clinical Information: This module houses the various forms, submission rationale, 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.