ctd triangle - ich official web site : ich · pdf filethe ctd triangle. the common technical...
TRANSCRIPT
Module 1
Regionaladministrative
information
Not partof the CTD
The CTD
Module 3
Module 2
Quality
Module 4
Non-clinicalstudy reports
Module 5
Clinical studyreports
Quality overallsummary
Non-clinicaloverview
Non-clinicalsummary
Clinicalsummary
Clinicaloverview
The CTD triangle. The Common Technical Document is organized into five modules. Module 1is region specific and modules 2, 3, 4 and 5 are intended to be common for all regions.
CTD Triangle