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Subject Narratives for Clinical Study Reports

Level:
Foundation
Area:
Drug Development
Code:
DDF11a
Duration:
03:30:00
Workshop profile:
This workshop is intended for medical writers who are familiar with the clinical development process but have no or limited experience in writing subject narratives for clinical study reports.
Objective:
Participants will acquire knowledge of the requirements and criteria for writing subject narratives within the framework of relevant ICH guidelines. They will obtain an understanding of the narrative writing process, including sources of data, presentation of information, important functional groups contributing to the narratives, and techniques for narrative generation. This will enable the writer to prepare high-quality narratives and optimise narrative writing activities.
Content:
The following topics will be discussed during the first part of the workshop: • Relevant sections of the ICH guidelines, emphasising the purpose of narratives • Definition of narrative criteria and categories • Content, including sources of information and data, the role of clinical trial and pharmacovigilance databases, recycling of information from CIOMS forms • The narrative writing process, including formats, templates, use of programmed data, coordination with other functional groups, quality control, tips for handling narratives in large studies During the second part of the workshop participants will be divided into groups and asked to write a simple narrative based on tables and listings.