Module 4 Non-Clinical Study Reports

Module 4 Non-clinical study reports Table of contents Study reports Literature references... 

Module 4 - Non-clinical Study Reports covers reports on animal and in vitro tests, which must be presented in the order described in Guideline M4S... 

C. Key Literature References Module 4 Non-clinical Study Reports... 

CTD consists of four modules, preceded by a Module 1 that is region-specific and includes administrative and prescribing information. Module 2 comprises of CTD summaries and overviews of the quality, non-clinical and clinical data. Module 3 contains data on quality. Module 4 consists of the non-clinical study reports and Module 5 comprises the clinical study reports. There are guidelines on the details to be included in each module and these are summarised in Box 17.2. The non-clinical and clinical overviews and summaries are equivalent to the previous Expert Reports submitted under sections IC2 and IC3 respectively of part I, data. 

M4 is another very important multidisciplinary guideline, which combines information for the 3 disciplines within the ICH Process for Quality, Safety and Efficacy. The following section focuses predominantly on the preclinical safety issues. The total document is divided into 5 modules Module 1 contains regional specific aspects, it provides for the European Union e.g. the European Community specific data. This module therefore is not harmonized but region-specific. Module 2 provides the Summaries for Quality, for Safety and Efficacy. The quality part uses as a headline Quality Overall Summary , for safety and efficacy the terms Non-Clinical or Clinical Overview . The different names signal that the quality part is a clear summary, while the non-clinical and clinical part should be critical evaluations. Module 3 provides chemical, pharmaceutical and biological information. Module 4 contains the non-clinical reports and Module 5 provides clinical study reports. 

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