GLOSSARY: Electronic Common Technical Document (eCTD)

Electronic Common Technical Document (eCTD) is a message specification for the transfer of files and metadata from a submitter to a receiver. The content is based on the Common Technical Document (CTD) format. It was developed by the International Conference on Harmonization (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). The eCTD has five modules: Administrative Information and Prescribing Information, Common Technical Document Summaries, Quality, Nonclinical Study Reports and Clinical Study Reports.