What is CTD?
CTD is the acronym for Common Technical Document. It was created by the ICH in an attempt to harmonize the format of applications. Essentially, there are five major parts of the CTD called Modules. Module 1 is region specific; in general administrative documentation and labeling is included here. Module 2 is a summary section; a summary of Modules 3, 4 and 5 are included here. Module 3 contains CMC (Chemistry Manufacturing Controls), Module 4 contains nonclinical/preclinical information (animal studies) and Module 5 contains clinical information (human studies). Visit the ICHs website for CTD for additional information. Each section is standardized to ease the location of information for reviewers and those creating the submissions.
Related Questions
- I am ordering a CTD and want to use auxiliary sensors. Should I order them from Sea-Bird also, or deal directly with the sensors’ manufacturers?
- I want to integrate a moored CTD with some auxiliary sensors (transmissometer, fluorometer, etc.). Which CTD should I use?
- How Metcon TMT Bars are resistant to earth quake compared to ordinary CTD bars?
