From my understanding, all countries under the ICH define and report Adverse Events the same way. Are there any other items/ideas within clinical research that all ICH countries have the same process for?

The ICH CTD is simplified into the 5 different modules as depicted in the CTD triangle. Simplistically, Module 1 includes the administrative and labeling requirements of the submission. Module 2 a table of contents of modules 2 through 5 and an overview of the technical date in modules 3 through 5. Module 3 includes a table of contents for module 3 and data on CMC. Module 4 includes a table of contents for module 4 as well as the reports for the nonclinical data. Finally, Module 5 contains the bulk of the information whjch is the table of content and data for the clinical study reports (in human studies).

Form FDA 356h is the form that should be completed and signed. It provides the reviewer with general information about the applications such as how the applicant can be reached, a description of the investigational product under review, sections included in the application, a certification statement, and etc.

In general it is vital to understand all of the below definitions in order to successfully submit a New Drug Application (NDA). As others have said, first and foremost you must recognize the type of application you need to submit (NDA or ANDA). Many of the other definitions will help the applicant to understand what is being asked for on the NDA. For example, the NDA might ask if this is an original application or a resubmission. By understanding these two words one can correctly fill out the NDA the first time and will save themselves and the reviewer time in the long run.