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Clinical Study Report Appendices

Drug Development
Workshop profile:
Medical writers working in the clinical research organisation or pharmaceutical company environment, as either employees or as freelancers. The workshop will meet the needs of writers tasked with preparing or performing quality control checks on appendices for clinical study reports (CSRs). This is an ideal forum for writers whose organisations or clients provide little guidance on appendix requirements, beyond provision of ‘ICH Guideline E3: Structure and content of clinical study reports’ and, further, may facilitate improvement in existing analysis and reporting processes and procedures.
The integrated CSR is a multi-component document comprising a text-based report and associated appendices. The text-based sections of the CSR are often given prominence and priority over the appendices, leaving the medical writer with insufficient time and resources to complete this necessary component of a full, integrated CSR. The workshop discusses time-planning and proactivity for appendices compilation as well as all the contents of Section 14 plus Appendices 16.1 to 16.4 inclusive. After completing the workshop, participants will understand how to best schedule appendices compilation and will understand the necessary content of each individual appendix.
The following topics will be covered: • Why prepare CSR appendices? • Requirements for ICH E3 Section 14 Appendices 16.1 - 16.4, adapted for MAAs (content in theory) • Hierarchical appendix filling structure • Time-planning for appendices compilation • Managing and tracking appendices contents • Set up of a hierarchical appendix filing structure Requirements for ICH E3 Section 14 Appendices 16.1 - 16.4, adapted for MAAs (content in practice) • Communication and management • Scheduling appendices • Narratives: administrative and management aspects • Appendices for abbreviated CSRs • Electronic transfer of appendices • Appendices for device and observational study reports