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WorksheetsCLPT 804 ET CTD
Total questions: 10
Worksheet time: 5mins
Which module of ICH provides the guidelines for CTD?
M4
M3
M2
M8
ICH CTD modules categorized into______ types?
5
4
3
2
Module 1 of ICH CTD deals with?
Regional administrative information
Quality overall summary
Non-clinical study reports
Clinical study reports
Module 2 of ICH CTD deals with?
Regional administrative information
Quality overall summary
Non-clinical study reports
Clinical study reports
Module 3 of ICH CTD deals with?
Regional administrative information
Quality
Non-clinical study reports
Clinical study reports
Module 4 of ICH CTD deals with?
Regional administrative information
Quality
Non-clinical study reports
Clinical study reports
Module 5 of ICH CTD deals with?
Regional administrative information
Quality
Non-clinical study reports
Clinical study reports
Which module is not part of the ICH CTD?
Module 1
Module 2
Module 3
Module 4
What is meant by CTD?
The Common Technical Document
The Common Technical Dossier
The Common Terminology Document
The Common Technical Disaster
Module 1 is __________ and Modules 2, 3, 4 and 5 are intended to be common for all regions.
Region specific
Local specific
Region Isolation
Local Isolation
