The Common Technical Document
The Common Technical Document (CTD) defines the format and structure of the data for submission and organises the data into modules at the highest level, through nodes, to individual documents at the detailed level. The modules that comprise the CTD are Modules 2–5 of the submission and contain the scientific data and summaries. Module 1 of any submission is not part of the CTD and contains region-specific administrative information. The organisation of the data into modules and nodes is referred to as the 'granularity' of the submission and is tightly defined in published guidelines.
- ICH Guidelines
- Eudralex Volume 2B
- FDA Guidelines
- Japanese CTD specifications
- Canadian Revised Draft Guidance Document
The electronic CTD (eCTD)
Information about the electronic Common Technical Document can be found on our e-submissions page.