E3 Structure and Content of Clinical Study

E3 Structure and Content of Clinical Study Reports Dose-Response Studies... 

In guidance document ICH E3, Structure and Content of Clinical Study Reports, the FDA defines treatment-emergent signs and symptoms (TESS) as events not seen at baseline and events that worsened even if present at baseline. As simple as that may sound, it can sometimes be quite difficult to program. The important data variables that come into play are dosing record dates and times, adverse event start and stop times, and adverse event severity. All of these data variables need to be completed accurately for TESS to be calculated properly. 

ICH E3, Structure and content of clinical study reports. Geneva, International Conference on Harmonisation (ICH) Secretariat IFPMA, 1995. 

International Conference on Harmonization. Guideline for Industry—Structure and Content of Clinical Study Reports, ICH E3, 1995. http //www.ich.org/LOB/media/ MEDIA479.pdf [accessed October 10, 2007]. 

International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH). Topic E3 Note for Guidance on Structure and Content of Clinical Study Reports, CPMP/ICH/137/95. London European Agency for the Evaluation of Medicinal Products, 1996. 

ICH E3(1995) Structure and Content of Clinical Study Reports sets down the structure, down to the numbering of the sections and precisely what goes in each of those sections, required within the regulatory setting for reporting each study. Medical writers will work with statisticians to put these reports together. 

The last section of a Clinical Summary is recommended to contain a table entitled Listing of Clinical Studies (ETA). This table is also to be included in Module 5. Following the table are to be individual clinical study synopses organized in the same sequence as the clinical study reports in Module 5. The ICH E3 guideline on Structure and Content of Clinical Study Reports provides an example of a format for a clinical study report synopsis, which can be used for marketing applications in all ICH regions. 

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